A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.
Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.
Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date01 Aug 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06880744

/ RecruitingPhase 3

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Na?ve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are na?ve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Start Date17 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT07007091

/ RecruitingPhase 1

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

Start Date12 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Risankizumab-RZAA

100 Translational Medicine associated with Risankizumab-RZAA

100 Patents (Medical) associated with Risankizumab-RZAA

649

Literatures (Medical) associated with Risankizumab-RZAA

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Switching biologic agent in patients with psoriasis: a systematic review and meta-analysis

Review

Author: Sun, YuanQiang ; Zhao, XiTong ; Li, WenChao ; Liu, Hong ; Zhang, LiHong

BACKGROUND:

Multiple biologics are available for psoriasis treatment, but switching treatments is often necessary at some point. The choice between intraclass or interclass biologic switching has not been extensively investigated.

METHODS:

Two independent authors searched the databases PubMed and EMBASE for studies reporting on biologic switching in psoriasis patients. Our study was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines.

RESULTS:

A total of 19 publications, comprising 679 patients, were included. The intraclass switching group consisted of 519 patients, while the interclass switching group included 139 patients. For intraclass switching, there are respectively 160, 326 and 33 patients switched of TNF-α, IL-17, IL-23. For interclass switching, 11 patients switched from TNF-α to IL-17, 6 from IL-17 to IL-23, 41 from IL-17 to IL-12/23, 29 from IL-17 to TNF-α, 15 from IL-12/23 to IL-17, 8 from IL-12/23 to IL-23. After 12 weeks, the proportion of patients achieving Psoriasis Area and Severity Index (PASI)75 was significantly higher in the intraclass switching group compared to the interclass switching group. However, after 16-52 weeks, the PASI75 proportions were comparable between the groups.

CONCLUSION:

Intraclass switching shows better short-term efficacy than interclass switching. However, in the long term, both switching strategies are effective and safe. This study also shows that adalimumab, ixekizumab, and risankizumab are the preferred agents for intraclass switching, whereas guselkumab serves as the primary agent for interclass transitions.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Interleukin-23p19 inhibitors for the treatment of moderate-to-severe psoriasis: an expert opinion of real-world evidence studies in Europe

Review

Author: Thaçi, D. ; Ständer, S.

Background: Psoriasis is a chronic inflammatory disease affecting about 2% of the global population, with moderate-to-severe forms requiring systemic treatment for successful disease management. By targeting the interleukin (IL)-23p19 subunit of IL-23, the master cytokine of psoriasis pathogenesis, guselkumab, tildrakizumab, and risankizumab offer improved risk-benefit profiles.Objective: While randomized clinical trials (RCTs) provide controlled data, real-world evidence (RWE) offers insights into the performance of these therapies in diverse patient populations, including those with comorbidities or difficult-to-treat areas affected. With RWE on these inhibitors constantly emerging, a comprehensive overview and expert interpretation are essential for providing key insights into psoriasis management in clinical practice.Methods: This review, therefore, examined RWE on the effectiveness and safety of IL-23p19 inhibitors compared to their pivotal RCTs.Results: Despite some gaps between RCT and RWE outcomes, particularly in underrepresented subpopulations, IL-23p19 inhibitors show strong effectiveness and favorable safety across both settings in the short- and especially in the long term, accompanied by an improvement in health-related quality of life and reduction of the main symptoms.Conclusion: Altogether, these factors make these medicines ideal treatment options. Future research should focus on improving patient-reported outcomes, specifically addressing psychological and quality-of-life aspects, to further optimize psoriasis management.

01 Aug 2025·Lancet Gastroenterology & Hepatology

Development and validation of a novel Endoscopic ulcer Activity Score for Evaluation of Crohn's Disease (EASE-CD) using data from two randomised controlled trials

Article

Author: Mosli, Mahmoud ; Shackelton, Lisa M ; Maguire, Bryan R ; Peyrin-Biroulet, Laurent ; Rubin, David T ; Danese, Silvio ; Panaccione, Remo ; Sands, Bruce E ; Ma, Christopher ; Leong, Rupert W ; Khanna, Reena ; Rémillard, Julie ; Sparrow, Miles P ; Hindryckx, Pieter ; Jairath, Vipul ; Bressler, Brian ; Feagan, Brian G ; Hart, Ailsa L ; Zou, Guangyong ; D'Haens, Geert R

BACKGROUND:

Endoscopy is essential for measuring luminal disease activity in Crohn's disease. Existing indices for evaluating endoscopic Crohn's disease activity are only modestly correlated with clinical disease activity, contain items with ambiguous definitions and poor interobserver reliability, and do not have validated thresholds for defining clinically relevant changes. To address these issues, we conducted a multiphase study to develop and validate a novel endoscopic index for Crohn's disease.

METHODS:

Paired baseline and post-induction ileocolonoscopy videos from a phase 3b adalimumab trial (NCT00348283) and phase 2 risankizumab trial (NCT02031276) were assessed by multiple central readers using candidate endoscopic items with face validity derived using modified RAND/UCLA appropriateness methods. The four readers were masked to all clinical information, including treatment assignment and patient symptom scores. A total of 112 and 99 paired ileocolonoscopy videos with treatment assignment were available from the adalimumab trial and risankizumab trial, respectively; after the four readers assessed the 112 videos, two readers then reassessed 44 post-treatment videos to assess inter-rater reliability in index development. Items with acceptable inter-rater reliability (with an intraclass correlation coefficient [ICC] of ≥0·41) and responsiveness (win probability [WinP], the probability that a patient receiving active treatment has a better endoscopy score than a patient receiving placebo, of ≥0·56) were included as covariables in regression for model building with internal validation with bootstrapping. External validation was conducted using the paired videos from the risankizumab trial.

FINDINGS:

Ten endoscopic items met ICC and WinP thresholds and were considered for novel index development. They included items from the SES-CD (presence and size of ulcers, extent of ulcerated surface, and extent of affected surface) and CDEIS (percentage of surface involved by Crohn's disease, percentage of ulcerated surface, deep ulceration, and superficial ulceration) and exploratory items (presence of Crohn's disease-related lesions, Crohn's disease-related lesion severity, and Crohn's disease-related lesion involvement). The final model, Endoscopic ulcer Activity Score for Evaluating CD (EASE-CD), included the presence and size of ulcerations measured on an ordinal scale of 0 (none), 1 (ulcers <5 mm), 2 (ulcers between 5 mm and 20 mm), and 3 (ulcers >20 mm); the presence or absence of deep ulcerations measured dichotomously, with 0 for absent and 1 for present; and the proportion of ulcerated surface area, expressed as a continuous proportion from 0-1, with each item evaluated and averaged across visualised bowel segments. The total score ranges from 0-100 with higher scores indicating greater endoscopic activity. The r² and optimism adjusted r² of EASE-CD in internal validation were 0·608 and 0·554, and the index was well calibrated with a slope of 0·983. In external validation, the adjusted r² was 0·565 and the calibration slope was 0·997. EASE-CD also demonstrated substantial inter-rater reliability (ICC 0·798 [95% CI 0·711-0·836]) and a large degree of responsiveness (WinP 0·769 [95% CI 0·658-0·851], p<0·001) in external validation. A 10-point reduction in EASE-CD had 82·4% specificity (95% CI 78·6-86·0) and 69·9% sensitivity (63·3-76·4) for endoscopic response, defined by at least 50% reduction in SES-CD or CDEIS. Ulcer-free endoscopic remission results in EASE-CD score of 0.

INTERPRETATION:

EASE-CD is a novel, internally and externally validated continuous measure of endoscopic ulcer activity in Crohn's disease that is reliable and responsive to treatment.

FUNDING:

None.

364

News (Medical) associated with Risankizumab-RZAA

21 Jul 2025

·www.globenewswire.com

Oruka Therapeutics Announces IND Clearance for EVERLAST-A Phase 2a Trial of ORKA-001 in Psoriasis with Phase 1 Data to be Presented at EADV in September

IND cleared for the EVERLAST-A Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis, with initial data expected 2H 2026 Interim Phase 1 data and further details on EVERLAST-A study design to be shared in an oral presentation at EADV in September MENLO PARK, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- 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 the U.S. FDA cleared its investigational new drug (IND) application for its Phase 2a trial of ORKA-001 (the Company’s long-acting anti-IL-23p19 antibody) in moderate-to-severe psoriasis, called EVERLAST-A. “We’re thrilled by this rapid progress into Phase 2 development, and very excited to start our first psoriasis study,” said Lawrence Klein, PhD, CEO of Oruka. “We think that ORKA-001 can redefine the standard of care in this important disease with potential for once per year dosing, off-treatment remissions and higher rates of disease clearance.” The U.S. FDA cleared the Company’s IND submission to initiate EVERLAST-A. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI 100 at Week 28 will receive ORKA-001 every six months. Additional details on the EVERLAST-A design, as well as interim data from the ORKA-001 Phase 1 study, will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September. The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. "We have made great strides in our ability to treat psoriatic disease, but many patients are still seeking improved treatment options. I’m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications. There is evidence now that these improvements could be within reach, and they would be a significant step forward for both patients and the field,” commented Bruce Strober, MD, PhD, the lead Principal Investigator on the EVERLAST-A study on behalf of Oruka’s Scientific Advisory Board. Oruka’s Scientific Advisory Board played a key role in designing the EVERLAST clinical program. Other SAB members include Drs. Andy Blauvelt, Joel Gelfand, Johann Gudjonsson, Mark Lebwohl, James Kreuger, and Joe Merola, all leading physicians whose work has underpinned advances in the psoriasis treatment landscape over the last 25 years. About ORKA-001 ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab. 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. Financial Disclosures Oruka’s SAB members receive compensation as scientific advisors. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including timelines to clinical and data release milestones, the details of its clinical studies, the potential half-life and exposures of ORKA-001 and its potential dosing interval as well as the potential of ORKA-001 treatment to lead to off-treatment remissions and/or higher rates of disease clearance than other treatments. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein 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 in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 alan.lada@orukatx.com

Phase 2Phase 1IND

02 Jul 2025

·endpoints.news

AbbVie cans oral ulcerative colitis drug from Landos buyout

AbbVie terminated work on the main drug from last year’s $137 million buyout of Landos Biopharma . It’s an abrupt end for ABBV-113, formerly known as NX-13, in ulcerative colitis. AbbVie culled a Phase 2 trial of the drug this week, per the federal trials database. The move was “not safety-related,” the drugmaker said in the trial update. In an emailed statement, an AbbVie spokesperson said the decision was “due to an inadequately differentiated benefit-risk assessment.” The spokesperson declined to say anything about future development “at this time.” The experimental anti-inflammatory drug is an NLRX1 agonist. Activation of NLRX1 is thought to impact “multiple mechanisms” that drive inflammatory bowel disease, AbbVie said at the time of the Landos deal. “This will be a robust Phase 2 with a placebo comparator, and we’ll get objective data from centralized review of endoscopic data,” AbbVie chief scientific officer Roopal Thakkar said in January, according to an AlphaSense transcript of the company’s fourth-quarter earnings call. “If it looks good, [it] definitely would be a Phase 3 asset for us.” The Chicago-area pharma giant bought Landos with the aim of making a first-in-class oral small molecule for the autoimmune condition, as well as studying the drug in other indications, like Crohn’s disease. An oral drug would be a more convenient option for patients. Much of AbbVie’s work in I&I is concentrated on injectable or infused drugs, including the world’s once top-selling medicine Humira, and Skyrizi, initially approved in 2019. It now also markets Rinvoq, an oral medicine approved for multiple inflammatory conditions. AbbVie has staked much of its mid-term future on Skyrizi and Rinvoq, expecting $31 billion in combined sales in 2027 from the two medicines. AbbVie also saw potential in combining ABBV-113 with its other drugs. If ABBV-113 had succeeded, the company planned to test it in combination with Rinvoq, according to Thakkar’s remarks in January. Meanwhile, AbbVie has padded its longer-term autoimmune pipeline with multiple collaborations and two small I&I acquisitions last year for Celsius Therapeutics and Nimble Therapeutics . It’s also working on oral medicines.

AcquisitionDrug ApprovalPhase 2Phase 3

01 Jul 2025

·www.pharmaceutical-technology.com

AbbVie buys $2.1bn Capstan, adding new in vivo CAR-T to pipeline

Shares in NYSE-listed AbbVie closed 1.7% higher following the deal. Valeriya Zankovych via Shutterstock. AbbVie has agreed to acquire Capstan Therapeutics for up to $2.1bn, adding a “high-risk, high-reward” clinical-stage in vivo CAR-T candidate to its pipeline. Capstan is developing a new type of CAR-T therapy that overcomes limitations with current options. Currently approved therapies of this kind act by upgrading patient-extracted T cells’ ability to fight cancer cells, but this method has financial and scalability hurdles, along with a lymphodepleting chemo requirement, curbing uptake. Capstan’s lead asset, CPTX2309, is an in vivo targeted lipid nanoparticle (LNP) anti-CD19 CAR-T therapy that could solve these issues. AbbVie certainly sees the promise in the drug, paying $2.1bn upfront to take control of the CAR-T therapy alongside other preclinical programmes and the RNA payload-delivering technology used to create them. CPTX2309, being developed for the treatment of B-cell-mediated autoimmune diseases, is already being evaluated in a Phase I study (NCT06917742) with healthy volunteers. A preliminary look at the data from Capstan has revealed strong B-cell depletion – the aim of the treatment is to achieve an ‘immune reset’ by repopulation of healthy B cells. Investors shared positive sentiment in the acquisition, with shares in NYSE-listed AbbVie closing 1.7% higher at $185.62 on 30 June, the day the announcement was made. The big pharma has a market cap of $327.9bn. This is not the first in vivo CAR-T relationship that AbbVie has fostered, with a collaboration with Umoja Biopharma in January 2024. This partnership allows AbbVie to develop in-situ generated CAR-T cell therapy candidates in oncology using Umoja’s VivoVecplatform. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “High-risk, high-reward” potential, says analysts William Blair analyst Matt Phipps said in a research note: “While CPTX2309 is still in early clinical development, we believe the acquisition shows a strategic effort by AbbVie to further strengthen its immunology franchise through novel, disease-modifying mechanisms. “Given the stage of development, this asset clearly comes with clinical risk, but given the potential of in vivo CAR-T, which does not require lymphodepletion and has potential for greater manufacturing scalability, it offers significant long-term upside if successful.” Phipps, who described AbbVie’s new asset as “high-risk, high-reward,” said the purchase consolidates AbbVie’s strong trading. The big pharma company has already shrugged off the loss of market exclusivity for its blockbuster Humira (adalimumab) by rolling out Skyrizi (risankizumab) and Rinvoq (upadacitinib). According to William Blair, forecast revenue rate from 2024 to 2029 growth rate for AbbVie trails only Eli Lilly and Sanofi, representing an “attractive opportunity” for long-term investors. Capstan’s CEO Laura Shawver said: “In vivo CAR-T represents a potential new treatment modality in medicine – embodying the transformative power of cell therapy with the accessibility and scalability of an off-the-shelf biologic. This technology has the potential to become a first-in-class platform to treat a wide range of autoimmune diseases.” Interius BioTherapeutics and Umoja Biopharma are two biotechs in the in vivo CAR-T arena that have assets in clinical trials targeting oncological indications. These assets also use lentiviral vectors to generate the cells in vivo, whereas Capstan is using mRNA. CPTX2309 is built on Capstan’s targeted LNP platform to enable in vivo delivery of RNA payloads to target cells. CPTX2309 is made up of an anti-CD19 CAR mRNA payload inside an LNP. AbbVie’s purchase comes just a few days after the US Food and Drug Administration (FDA) removed an access barrier for currently approved CAR-T therapies, regarded as a boost to the sector’s outlook. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Navigating cell therapy process development The cell therapy manufacturing sector is rapidly evolving, driven by the need to balance innovative process development with rigorous GMP standards. This eBook, brought to you by industry leaders Cytiva, explores how biotech firms can address common challenges — including minimizing contamination risks from manual processes, overcoming resource limitations, and creating scalable, robust designs. Industry experts discuss strategies including automation, strategic outsourcing, and flexible equipment selection to streamline processes and reduce regulatory risks. To unlock expert insights on optimizing your cell therapy pathway from clinical development to commercialization, fill in your details now. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic You have a right to withdraw your consent at any time, by clicking here . We may still continue to send you service-related and other non-promotional communications. For more information relating to our privacy practices, we invite you to review our privacy policy . Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

ImmunotherapyCell TherapyAcquisitionPhase 1

100 Deals associated with Risankizumab-RZAA

External Link

KEGG	Wiki	ATC	Drug Bank
-	Risankizumab-RZAA	L04AC18	DB14762

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	China	AbbVie, Inc.	04 Mar 2025
Crohn's disease, active severe	China	AbbVie, Inc.	04 Mar 2025
Colitis, Ulcerative	Japan	AbbVie, Inc.	26 Sep 2022
Crohn Disease	Australia	AbbVie Pty Ltd.	16 Jul 2019
Ulcerative colitis, active moderate	Australia	AbbVie Pty Ltd.	16 Jul 2019
Ulcerative colitis, active severe	Australia	AbbVie Pty Ltd.	16 Jul 2019
Plaque psoriasis	Canada	AbbVie, Inc.	17 Apr 2019
Arthritis, Psoriatic	Japan	AbbVie, Inc.	26 Mar 2019
Erythrodermic psoriasis	Japan	AbbVie, Inc.	26 Mar 2019
Psoriasis vulgaris	Japan	AbbVie, Inc.	26 Mar 2019
Pustular psoriasis	Japan	AbbVie, Inc.	26 Mar 2019
Pustulosis of Palms and Soles	Japan	AbbVie, Inc.	26 Mar 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	Phase 3	United States	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Australia	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Canada	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	France	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Germany	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Italy	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Poland	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Spain	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	United Kingdom	AbbVie, Inc.	08 Jul 2024
Keratoderma, Palmoplantar	Phase 3	United States	AbbVie, Inc.	26 Feb 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04435600 (OptIMMize-1, CTgov)	Phase 3	Plaque psoriasis \| Chronic large plaque psoriasis	139	Risankizumab (Part 1: Risankizumab)	govnavhhkz = cryiymhigx fnomwjgvzz (pzgndtjrbu, lmfkughjpx - jxzizkyevs) View more	-	20 May 2025
				Ustekinumab (Part 2 Period A: Ustekinumab)	govnavhhkz = uvuudqynhq fnomwjgvzz (pzgndtjrbu, uokhgbfojp - goktedusxi) View more
ADVANCE, MOTIVATE, FORTIFY (Pubmed \| J Crohns Colitis)	Phase 3	Perianal fistula due to Crohn's disease Maintenance high-sensitivity C-reactive protein (hs-CRP) \| fecal calprotectin (FCP)	748	Risankizumab 600 mg	kruqqwionm(iyhgxpgxye) = ihbkpnzuqn wxipuhcpvp (ncumnqjhjg ) View more	Positive	04 Apr 2025
				Risankizumab 180 mg	kruqqwionm(iyhgxpgxye) = xqcssvowml wxipuhcpvp (ncumnqjhjg ) View more
NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	Phase 3	Perianal fistula due to Crohn's disease anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	licsqrtkrq(lyiiuvacly) = pdodwpfeqi joicgiunsn (onexhhkdeq ) View more	Positive	01 Feb 2025
				Risankizumab 180 mg SC	licsqrtkrq(lyiiuvacly) = lnmzchpnna joicgiunsn (onexhhkdeq ) View more
FORTIFY (Pubmed \| Gastro Hep Adv)	Phase 3	Crohn Disease Maintenance	-	Risankizumab	vxutxwhygd(xtnzzrmfco) = jbulhfzmjg wcbvnskvqg (mejvugespf )	Positive	01 Jan 2025
NCT03047395 (LIMMitless, CTgov)	Phase 3	Plaque psoriasis \| Chronic large plaque psoriasis	2,170	Risankizumab	ategetllfx = mzngtskbqv divbahtogy (xawltsyggq, tlnvuelycw - lvptnfhvyd) View more	-	11 Dec 2024
UEGW2024	Not Applicable	Perianal fistula due to Crohn's disease	-	Risankizumab	qzrwfvkjha(gzxyubkgiq) = documented in 12.6% (32/253) of patients, including fatigue, pruritus, nausea, joint pain, and upper-respiratory tract infection txlscwlpks (nhxbyffshi ) View more	-	13 Oct 2024
				Risankizumab (Ustekinumab-naïve patients)
NCT03105102 (FORTIFY, UEGW2024)	Phase 3	Crohn's disease, active moderate Maintenance interleukin-23 p19 subunit	710	Risankizumab 180 mg	latpniygds(lqnlbiabbg) = mocvdfehlw bcwipbcwgi (dozmuwvtwf ) View more	Positive	13 Oct 2024
				Risankizumab 360 mg	latpniygds(lqnlbiabbg) = yjagttpvff bcwipbcwgi (dozmuwvtwf ) View more
RISANCROHN STUDY (UEGW2024)	Phase 3	Refractory sprue C-reactive protein (CRP) \| faecal calprotectine (FC)	417	Risankizumab	mgmkvblcek(foacrqtbue) = 23 patients (5.5%) presented adverse events including 6 infections uxucgwjxot (laishfvsqb ) View more	Positive	13 Oct 2024
NCT04524611 (SEQUENCE, UEGW2024)	Phase 3	Crohn Disease	-	Risankizumab	uvopwkbybr(vrmuytzhbc) = mmunabpzxu azapbnqicr (dzyochxvoj ) View more	Positive	13 Oct 2024
				Ustekinumab	uvopwkbybr(vrmuytzhbc) = jtlxlbztoo azapbnqicr (dzyochxvoj ) View more
NCT03398148 \| NCT03398135 (INSPIRE \| COMMAND, UEGW2024)	Phase 3	Colitis, Ulcerative Maintenance high-sensitivity C-reactive protein	650	Risankizumab 1200 mg IV	prxdansbrq(ealtcokoqb) = mlsjjaefvc mbzpvhlbej (frweqpmwho, 18.4 - 26.8) View more	Positive	13 Oct 2024
				Placebo IV	prxdansbrq(ealtcokoqb) = ovflygoyqq mbzpvhlbej (frweqpmwho, 4.1 - 11.9) View more

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