The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is:
What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index.

Start Date01 May 2025

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

NCT06786936

/ Not yet recruitingNot ApplicableIIT

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

The investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
Glutamate concentration in the NAcc will be positively correlated with the magnitude of the inflammatory response and will be attenuated by IL-17A inhibition. Ultimately, this will be associated with an improvement in depressive symptoms.
The strength of coupling between early and late systems will be attenuated in the context of IL-17A-driven inflammation and will be correlated with less frequent switching behaviour following negative outcomes and ultimately depressive symptoms. This coupling will be re-established following IL-17 antagonism.
Patients whose depressive symptoms benefit most from IL-17A antagonism will exhibit greatest resting-state and task-specific functional connectivity between Th-NAcc.

Start Date28 Feb 2025

Sponsor / Collaborator

NHS Greater Glasgow & Clyde

[+2]

NCT05309616

/ RecruitingPhase 2IIT

Effects of IL-17A Inhibition on Idiopathic Subglottic Stenosis

The purpose of this phase 2 study is to examine if inhibiting IL-17A activation using the biologic drug Taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries.

Start Date20 Feb 2025

Sponsor / Collaborator

Yale University

100 Clinical Results associated with Ixekizumab

100 Translational Medicine associated with Ixekizumab

100 Patents (Medical) associated with Ixekizumab

1,101

Literatures (Medical) associated with Ixekizumab

01 Jun 2025·RHEUMATOLOGY

Incidence rates of tuberculosis and inflammatory bowel disease in patients with ankylosing spondylitis treated with biologics in Korea

Article

Author: Park, Min-Chan ; Paul, Thomas ; Yang, Juyeon ; Kwon, Oh Chan ; Lee, Youkyung ; Lee, Hye Sun ; Jin, Hyerim

Abstract:

Objective:

To describe the incidence rates of inflammatory bowel disease (IBD) and tuberculosis (TB) in Korean patients with ankylosing spondylitis receiving biologics.

Methods:

Data from a Korean claims database between 2010 and 2021 was used to calculate crude incidence rates of TB and IBD using number of events and total patient-years (PYs).

Results:

Overall, 43 643 and 43 396 patients were included in TB and IBD cohorts, respectively. Exposure-adjusted incidence rates (EAIRs) of TB for non-exposure, TNF inhibitors (TNFis), and IL-17 inhibitors (IL-17is) were 0.14, 0.25 and 0.12 and of IBD were 0.18, 0.19 and 0.44 per 100 PYs, respectively. Incidence rates during biologic DMARD (bDMARD) non-exposure, adalimumab, etanercept, golimumab, infliximab, secukinumab and ixekizumab exposures for TB were 13.96, 27.79, 14.28, 21.19, 33.62, 12.74 and 0.00 and for IBD were 18.29, 19.98, 22.41, 18.85, 15.73, 44.99 and 0.00 per 10 000 PYs, respectively. Compared with bDMARD non-exposure, adalimumab, golimumab and infliximab exposures were associated with a significantly higher risk of TB. Etanercept and secukinumab exposure showed no significant increase in risk of TB. Compared with bDMARD non-exposure, exposure to biologics did not show a significant difference in risk of IBD.

Conclusion:

EAIRs of TB and IBD with use of IL-17is in patients with AS were within anticipated low range. IL-17is had numerically lower incidence of TB, and numerically higher incidence of IBD compared with TNFis. Notably, secukinumab showed no increased risk of TB compared with bDMARD non-exposure. Neither TNFis nor IL-17is showed increased risk of IBD compared with bDMARD non-exposure.

30 May 2025·MEDICINE

Psoriasis complicated with polymyositis successfully treated with Ixekizumab: A case report.

Article

Author: Liu, Jifeng ; Chen, Shengli

RATIONALE:

Psoriasis is an immune-mediated chronic inflammatory skin disease that is rarely complicated by polymyositis in clinical practice. Here, we report a patient with psoriasis, following treatment with Etanercept, who exhibited an increase in creatine kinase (CK) levels and a decline in muscle strength. After combined treatment with methylprednisolone, methotrexate, and Ixekizumab, the psoriasis rash completely subsided and CK levels returned to normal.

PATIENT CONCERNS:

The patient was a 22-year-old female with systemic erythema and scale itching for 3 months, and her serum CK level was 1711 U/L without muscle pain and muscle weakness. She was diagnosed with psoriasis and myositis awaiting investigation and was then treated with Etanercept at 50 mg weekly. At the 6-month follow-up with ongoing Etanercept treatment, her serum CK level was elevated to 3465 U/L. Electromyography and thigh magnetic resonance imaging revealed myositis. After methylprednisolone and methotrexate tablet treatment for polymyositis, she developed pulmonary pneumonia, and methotrexate and methylprednisolone tablets were withdrawn. Although the pneumonia was controlled, the facial erythema, plaques, scales, and rash gradually increased and spread all over the body. Moreover, gastrocnemius pain and fatigue persisted. The patient was treated with subcutaneous injection of 160 mg of Ixekizumab combined with methylprednisolone tablet (8 mg/d), after 2 weeks, the dosage was reduced to 80 mg once every 2 weeks, and the patient's psoriastic rash had completely disappeared after 4 weeks. The patient continued to receive subcutaneous injections of Ixekizumab 80 mg once a month and methylprednisolone tablet 6 mg every day. Six months later, no rash recurrence was noted and her CK level was within the normal range.

DIAGNOSES:

The patient was diagnosed with psoriasis with polymyositis.

INTERVENTIONS:

After combined treatment with methylprednisolone, methotrexate, and Ixekizumab, the psoriasis rash completely subsided and CK levels returned to normal.

OUTCOMES:

Our case shows that Ixekizumab is an effective treatment for psoriasis complicated with polymyositis, which is worth clinical application.

LESSONS:

Although Etanercept can be used to treat psoriasis and dermatomyositis, it can also aggravate the myositis. Ixekizumab is an effective treatment for psoriasis complicated by polymyositis.

23 May 2025·CLINICAL AND EXPERIMENTAL DERMATOLOGY

Safety of interleukin-17A inhibitors in 306 patients with psoriasis with or without latent tuberculosis: a dual-centre retrospective study in China

Article

Author: Lv, Chengzhi ; Liu, Yizhang ; Duan, Yongfang ; Zhang, Mi ; Hu, Kun ; Jian, Lu ; Sha, Yang ; Kuang, Yehong

Abstract:

Background:

New interleukin (IL)-17A inhibitors seem to demonstrate smaller effects on tuberculosis (TB) reactivation than expected.

Objectives:

To evaluate the risk of TB reactivation, to assess serial interferon (IFN)-γ levels, and to weigh up the risks and benefits of TB chemoprophylaxis in patients with psoriasis treated with IL-17A inhibitors.

Methods:

This dual-centre study included patients with psoriasis who were treated with IL-17A inhibitors. The incidence of active TB, serial IFN-γ levels tested by IFN-γ release assays (IGRAs), adverse events (AEs) and effectiveness were evaluated through 1 year in patients with psoriasis treated with IL-17A inhibitors. According to the chemoprophylaxis treatment regimen, patients with latent TB infection (LTBI) were classified into three groups: a complete chemoprophylaxis dose regimen (CCP), an incomplete chemoprophylaxis (ICCP) or no chemoprophylaxis (NCP).

Results:

In 220 IGRA-negative patients, 17 of 220 (7.3%) became IGRA positive after receiving a mean of 69.1 weeks of IL-17A inhibitor treatment. Only one case of new-onset TB was observed after 52 weeks of ixekizumab therapy. Significant changes in IFN-γ levels were observed in IGRA-negative patients. Similarly, IFN-γ levels [listed as the mean (SD)] significantly increased at 1 year compared with baseline among IGRA-positive patients in the NCP [105 (68.7) vs. 236 (80.8) pg mL−1, P < 0.01] and ICCP [75.3 (48.3) vs. 608 (249) pg mL−1, P < 0.001] groups, whereas the changes were not significant [125 (26.6) vs. 131 (21.7) pg mL−1, P = 0.70] in the CCP group.

Conclusions:

During IL-17A inhibitor therapy, there is a need for increased awareness of annual screening and assessment of individual risk for early detection of TB infection. LTBI treatment is generally well tolerated and is effective in preventing increased IFN-γ responses in patients with psoriasis treated with IL-17A inhibitors.

108

News (Medical) associated with Ixekizumab

28 May 2025

·www.einpresswire.com

Alvotech and Advanz Pharma Extend Strategic Partnership to Commercialize Three Additional Biosimilars in Europe

Advanz Pharma secures exclusive rights from Alvotech to commercialize three biosimilar candidates in Europe in addition to previously partnered programs The agreement includes proposed biosimilars to Ilaris ® (canakinumab), Kesimpta ® (ofatumumab) and an additional early-stage undisclosed biosimilar candidate REYKJAVIK, Iceland and LONDON, May 28, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates. The new agreement covers the supply and commercialization in Europe of biosimilar candidates to Ilaris ® (canakinumab), a human antibody interleukin-1β blocker indicated for the treatment of various inflammatory diseases, and Kesimpta ® (ofatumumab), a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis, in addition to a third undisclosed biosimilar candidate. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe. The agreement includes development and commercial milestones for the three products, totaling up to US$180 million at current exchange rates (EUR 160 million). In addition, the partners will participate in a revenue share. "We are very pleased to expand our partnership with Advanz Pharma. We now have agreed to launch proposed biosimilars to more than ten reference products in Europe, starting in 2025 and reaching beyond 2030. This new agreement demonstrates the business development potential and value of Alvotech’s growing biosimilars pipeline, that is unrivalled by any other biosimilars developer,” said Róbert Wessman, chairman and CEO of Alvotech. “By adding canakinumab, ofatumumab and another early-stage program to our strategic partnership with Alvotech, Advanz Pharma now holds European commercial rights to proposed biosimilars referencing more than ten originator biologics. Importantly, two of these three new candidates address rare-disease indications, reinforcing our commitment to broaden access to rare disease and specialty medicines. Biosimilars are a cornerstone of our growth strategy and this expanded collaboration positions us to deliver sustainable value for patients and healthcare systems alike,” said Steffen Wagner, CEO, Advanz Pharma. Alvotech and Advanz Pharma previously entered into partnership agreements, signed in 2023, to commercialize proposed biosimilars to Xolair ® (omalizumab), Simponi ® (golimumab), Entyvio ® (vedolizumab), Eylea ® (aflibercept) and Eylea ® HD (aflibercept), Dupixent ® (dupilumab), Taltz ® (ixekizumab) and Tremfya ® (guselkumab). The supply and commercialization agreements cover all 30 member countries of the European Economic Area, as well as the UK and Switzerland. For omalizumab, the agreement additionally includes Canada, Australia, and New Zealand. According to IQVIA, the current addressable market for the proposed biosimilars covered by the partnership agreements between Alvotech and Advanz Pharma in the countries in scope is now at least US$13.8bn. Use of trademarks Simponi ® and Tremfya ® are registered trademarks of Johnson & Johnson Inc. Xolair ® , Ilaris ® and Kesimpta ® are registered trademarks of Novartis AG. Eylea ® is a registered trademark of Regeneron Pharmaceuticals, Inc. Entyvio ® is a registered trademark of Millennium Pharmaceuticals, Inc. Dupixent ® is a trademark and brand of Sanofi Biotechnology. Taltz ® is a registered trademark of Eli Lilly and Company. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Alvotech Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech’s manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech’s pipeline products. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech’s ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Alvotech’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. Advanz Pharma Forward Looking Statements Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although ADVANZ believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz’s markets, and other factors beyond the control of Advanz. Neither ADVANZ nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. MEDIA CONTACTS Alvotech Global Communications and Investor Relations Benedikt Stefansson alvotech.ir@alvotech.com Advanz Pharma Global Corporate Communications Courtney Baines Tel: +44 7776 516979 courtney.baines@advanzpharma.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

License out/inBiosimilar

21 May 2025

·pipelinereview.com

Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-002, its Novel Half-life Extended Anti-IL-17A/F Antibody

Pharmacokinetic and safety data from healthy volunteers anticipated around YE 2025 On track to initiate a Phase 2 study in 1H 2026 ORKA-002 preclinical data demonstrate the potential for dosing two to three times per year in psoriasis, a significant improvement over standard of care MENLO PARK, CA, USA I May 20, 2025 I Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F). “With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.” The ORKA-002 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of ORKA-002 in approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study around year end 2025. Pending data from the Phase 1 trial, Oruka plans to initiate a Phase 2 study of ORKA-002 in moderate-to-severe psoriasis in the first half of 2026. The planned study design will evaluate the safety and efficacy of multiple dose levels and regimens of ORKA-002, with a primary endpoint of PASI 100 at week 16. “ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.” About ORKA-002 ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing <120 kg, where Q8W maintenance dosing is recommended. In contrast, ORKA-002 has the potential to be dosed just two to three times per year in PsO and PsA, which we believe could allow ORKA-002 to become the leading therapy in the IL-17 class. Data from studies in non-human primates and other preclinical assays show that ORKA-002 binds to a similar epitope with similar affinity as bimekizumab and has a significantly extended half-life over three times longer than bimekizumab. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. SOURCE: Oruka Therapeutics

Phase 1Phase 3Clinical Result

21 May 2025

·pipelinereview.com

Zura Bio Launches Global Phase 2 TibuSHIELD Study to Evaluate Tibulizumab in Adults with Hidradenitis Suppurativa

HENDERSON, NV, USA I May 20, 2025 I Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio” or the “Company”), a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs, today announced the launch of TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS. “Hidradenitis suppurativa remains a difficult condition to manage, with many patients experiencing persistent disease activity despite currently available treatments,” said Alexa B. Kimball, MD, MPH, Professor of Dermatology at Harvard Medical School, and President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. “Studying tibulizumab represents an important opportunity to evaluate an investigational therapy designed to target multiple aspects of the inflammatory process in HS. We look forward to investigating this approach for individuals living with this challenging disease.” TibuSHIELD is designed to enroll approximately 180 adults with moderate to severe HS across the United States, Canada, and Europe. The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with an optional OLE. Topline results for the primary efficacy endpoint at Week 16 are expected in the third quarter of 2026. “The initiation of TibuSHIELD marks a key milestone in our mission to advance potentially differentiated therapies for patients with severe inflammatory diseases, ” said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. “Tibulizumab’s dual mechanism of action, targeting both BAFF and IL-17A, offers a novel approach for the potential treatment of hidradenitis suppurativa. We remain committed to advancing clinical development with investigators, clinical sites, and the HS community.” The launch of this HS study follows the December 2024 initiation of TibuSURE, a global Phase 2 study evaluating tibulizumab in adults with systemic sclerosis. Tibulizumab remains an investigational product and has not been approved by any regulatory authority. Its safety and efficacy have not yet been established. ABOUT TibuSHIELD TibuSHIELD is a global, Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, and efficacy of tibulizumab in approximately 180 adults with moderate to severe HS. Participants are randomized 1:1:1 to receive two different doses of tibulizumab or placebo. The study includes a 16-week efficacy assessment period followed by a 12-week safety follow-up and an optional OLE. The primary endpoint of the study is the percent change from baseline in total abscess and nodule (AN) count at Week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in AN count without an increase in abscesses or draining fistulas at Week 16. Key safety assessments include the assessment of tolerability, and monitoring for adverse events. ABOUT HIDRADENITIS SUPPURATIVA Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic, progressive, and debilitating inflammatory skin disease affecting approximately 1% of the global population. HS primarily involves follicular occlusion, rupture, and secondary inflammation of hair follicles, leading to painful nodules, abscesses, sinus tracts (also referred to as draining tunnels), and scarring. Lesions typically occur in areas where skin rubs together, such as the armpits, groin, and under the breasts. HS is associated with several comorbidities, including inflammatory arthropathies, metabolic syndrome, increased cardiovascular risk, inflammatory disorders, lymphedema, squamous cell carcinoma, and depression. The chronic pain, visible scarring, and disease burden contribute significantly to physical disability, stigmatization, unemployment, and reduced quality of life. Currently, there is no cure for HS. Despite its relatively high prevalence and disease burden, treatment options remain limited, and many patients fail to achieve adequate disease control. ABOUT TIBULIZUMAB Tibulizumab is an investigational, humanized, tetravalent dual-antagonist antibody engineered by fusing Taltz® (ixekizumab) and tabalumab to bind to and neutralize both IL-17A and BAFF. It is currently being evaluated in two Phase 2 clinical studies in adults with systemic sclerosis and hidradenitis suppurativa. Prior to in-licensing, Phase 1/1b studies were conducted in patients with Sjögren’s syndrome and rheumatoid arthritis. Tibulizumab is an investigational compound and has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs. The Company’s pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two separate Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com . SOURCE: Zura Bio

Phase 2Immunotherapy

100 Deals associated with Ixekizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10071	Ixekizumab	L04AC13	DB11569

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Axial Spondyloarthritis	China	Eli Lilly & Co.	26 Jul 2022
Ankylosing Spondylitis	Canada	Eli Lilly & Co.	11 Aug 2016
Non-radiographic axial spondyloarthritis	Canada	Eli Lilly & Co.	11 Aug 2016
Spondylarthritis	Canada	Eli Lilly & Co.	11 Aug 2016
Erythrodermic psoriasis	Japan	Eli Lilly Japan KK	04 Jul 2016
Psoriasis	Japan	Eli Lilly Japan KK	04 Jul 2016
Psoriasis vulgaris	Japan	Eli Lilly Japan KK	04 Jul 2016
Pustular psoriasis	Japan	Eli Lilly Japan KK	04 Jul 2016
Arthritis, Psoriatic	European Union	Eli Lilly & Company (Ireland) Ltd.	25 Apr 2016
Arthritis, Psoriatic	Iceland	Eli Lilly & Company (Ireland) Ltd.	25 Apr 2016
Arthritis, Psoriatic	Liechtenstein	Eli Lilly & Company (Ireland) Ltd.	25 Apr 2016
Arthritis, Psoriatic	Norway	Eli Lilly & Company (Ireland) Ltd.	25 Apr 2016
Plaque psoriasis	United States	Eli Lilly & Co.	22 Mar 2016

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	United States	Eli Lilly & Co.	24 Sep 2024
Obesity	Phase 3	Puerto Rico	Eli Lilly & Co.	24 Sep 2024
Enthesitis-Related Arthritis	Phase 3	Argentina	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	Belgium	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	Czechia	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	Denmark	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	France	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	Germany	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	Italy	Eli Lilly & Co.	13 Apr 2021
Enthesitis-Related Arthritis	Phase 3	Mexico	Eli Lilly & Co.	13 Apr 2021

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04979910 (CTgov)	Phase 2	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	7	Ixekizumab	yxnkkvpdzp = larwdxhoty pvsuzdoqea (qgbeibbhos, ebvhnsblfe - epzgtfmmcf) View more	-	20 May 2025
NCT04285229 (Pubmed \| Rheumatol Ther)	Phase 3	Axial Spondyloarthritis C-reactive protein level	147	Ixekizumab 80 mg every 4 weeks	ngdeqlweec(odepnopyvp) = ezcxedexfd nfmwzpblfc (imyqpapqnt )	Positive	09 May 2025
				Placebo	ngdeqlweec(odepnopyvp) = shbguhgutx nfmwzpblfc (imyqpapqnt )
NCT03364309 (Phase 3 Trial, Pubmed \| Adv Ther)	Phase 3	Psoriasis	289	Ixekizumab	kgjenlrvwf(zunajdoqab) = AEs were comparable in patients who received continuous treatment and retreatment nbsclajxuv (teeealifrt )	Positive	13 Nov 2024
NCT02696785 (COAST-V, Pubmed) Manual	Phase 3	Axial Spondyloarthritis bDMARD-naïve \| r-axSpA	81	Ixekizumab 80 mg every 4 weeks	yhqpgsxbhg(nmlnaosxbh) = ownrxkoyzu wmcltuqkqv (izadhinoce ) View more	Positive	01 Jul 2024
NCT04527380 (COSPIRIT-JIA, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Enthesitis-Related Arthritis \| Juvenile Idiopathic Arthritis	101	Ixekizumab (All IXE)	dajvezkmjz(tycjebvket) = rwfijeblal axvpkrouqx (qngqqouhqt ) View more	Positive	12 Jun 2024
				Ixekizumab (Bio-Naive)	dajvezkmjz(tycjebvket) = kqgkdvjwvh axvpkrouqx (qngqqouhqt ) View more
EULAR2024	Not Applicable	Axial Spondyloarthritis First line HLA-B27	-	Ixekizumab	trfzkeiqwo(yqfozfwryl) = bbatrnbdyy nvmyouykwm (mzhwtxrgxx ) View more	Positive	05 Jun 2024
				Secukinumab	trfzkeiqwo(yqfozfwryl) = wwwnfjocqz nvmyouykwm (mzhwtxrgxx ) View more
NCT02696785 (COAST-V, EULAR2024)	Phase 3	Axial Spondyloarthritis	341	Ixekizumab Q4W	sptouxfsya(ljkqxbmxjt) = wejectwhnl wgyelwqtuq (jdnkuhmzvk ) View more	Positive	05 Jun 2024
				Ixekizumab Q2W	sptouxfsya(ljkqxbmxjt) = miqcimvndj wgyelwqtuq (jdnkuhmzvk ) View more
EULAR2024	Not Applicable	Axial Spondyloarthritis	-	Ixekizumab 80mg every 4 weeks	mgkhzeuyrj(wcbyuhceox) = ggcslphwnm iupawymzqq (nthqlzcmet )	-	05 Jun 2024
EULAR2024	Not Applicable	Non-radiographic axial spondyloarthritis	-	Ixekizumab 80 mg every 4 weeks	sxmmfwnjxa(dhwjgdljzx) = rbnrfvjejs wurpfnrpgy (ykpqtwfzjz ) View more	-	05 Jun 2024
				Placebo	sxmmfwnjxa(dhwjgdljzx) = parowcxacc wurpfnrpgy (ykpqtwfzjz ) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic \| Axial Spondyloarthritis interleukin 17A (IL17A)	335	Ixekizumab	fxlqxhlccf(kyzlydmgge) = itwlhkyfny zfnjtgqaun (qwjumnebys, 64.0 - 74.3)	Positive	05 Jun 2024

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