[Translation] A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Range Study to Evaluate the Efficacy and Safety of Rocatinlimab in Adult Subjects with Moderate to Severe Asthma

主要目的：评估Rocatinlimab 减少哮喘加重（急性发作）的有效性次要目的：评估Rocatinlimab 的安全性和免疫原性

[Translation]

Primary objective: To evaluate the effectiveness of Rocatinlimab in reducing asthma exacerbations (acute attacks) Secondary objectives: To evaluate the safety and immunogenicity of Rocatinlimab

Start Date11 Dec 2024

Sponsor / Collaborator

Amgen, Inc.

[+1]

NCT06438263

/ Active, not recruitingPhase 1

An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects

The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.

Start Date06 Aug 2024

Sponsor / Collaborator

Amgen, Inc.

NCT06527404

/ RecruitingPhase 3

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Start Date18 Jul 2024

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Rocatinlimab

100 Translational Medicine associated with Rocatinlimab

100 Patents (Medical) associated with Rocatinlimab

Literatures (Medical) associated with Rocatinlimab

22 Jan 2025·Immunotherapy

ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis

Article

Author: Hercogová, Janá Tresnak ; Eichenfield, Lawrence F. ; Charuworn, Prista ; Simpson, Eric ; Mano, Hirotaka ; Arai, Takahiro ; Kabashima, Kenji ; Wang, Andrea ; Luna, Paula C. ; Esfandiari, Ehsanollah ; Spelman, Lynda ; Bissonnette, Robert ; Worm, Margitta ; Guttman-Yassky, Emma ; Kricorian, Gregory

Atopic dermatitis (AD) is a chronic inflammatory disease affecting ~ 10% of adults and ~ 20% of children globally. Many patients with moderate-to-severe AD receiving systemic therapies, including biologics and Janus kinase (JAK) inhibitors, fail to reach or maintain treatment goals due to lack of durable response or safety/tolerability issues. Rocatinlimab is a T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. ROCKET, a large, global phase 3 program of eight clinical trials (NCT05398445; NCT05651711; NCT05724199; NCT05899816; NCT05704738; NCT05633355; NCT05882877; NCT06224192), will evaluate the efficacy, durability of response, and long-term safety of rocatinlimab as monotherapy and combination therapy in adult and adolescent patients with moderate-to-severe AD with or without prior exposure to biologics or systemic JAK inhibitors.

01 Dec 2024·Dermatology and Therapy

A Narrative Review of the OX40-OX40L Pathway as a Potential Therapeutic Target in Atopic Dermatitis: Focus on Rocatinlimab and Amlitelimab

Review

Author: Abdelhalim, Asaad ; Torres, Tiago ; Yilmaz, Orhan ; Elshaikh Berair, Mohamed

Atopic dermatitis (AD) is a common chronic inflammatory skin disease involving complex immune dysregulation, including the OX40-OX40L pathway. Rocatinlimab and amlitelimab, monoclonal antibodies targeting OX40 and OX40L, respectively, have shown promise in treating moderate-to-severe AD. Both therapies have demonstrated significant efficacy in reducing disease severity, with favorable safety profiles and no serious treatment-related adverse events. Both treatments outperformed placebo across key clinical endpoints, including skin clearance and symptom reduction, highlighting their potential as effective AD therapies. Although initial results are promising, further research is needed to evaluate the long-term effects, durability of response, and safety of these treatments. These findings support the therapeutic potential of targeting the OX40-OX40L pathway in AD, providing new options for patients with moderate-to-severe disease, with ongoing trials necessary to confirm their sustained benefits.

01 Dec 2024·Dermatology and Therapy

Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study

Article

Author: Dent, Jennifer E. ; Nixon, Annabel ; Guttman-Yassky, Emma ; Rylands, Angela J ; Williams, Angela ; Esfandiari, Ehsanollah ; Dent, Jennifer E ; Kabashima, Kenji ; Simpson, Eric ; Rylands, Angela J. ; Igawa, Ken ; Gooderham, Melinda

INTRODUCTIONIn adults with moderate-to-severe atopic dermatitis (AD), rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo. This post hoc analysis of a phase 2b study was undertaken to understand the disease burden and to assess the impact of rocatinlimab on patient-reported outcomes (PROs).METHODSThis analysis used baseline data from a multicenter, randomized, double-blind study of adults with moderate-to-severe AD, who completed a Worst Pruritus numerical rating scale (NRS), Sleep Disturbance NRS, and the Dermatology Life Quality Index (DLQI). A mixed model for repeated measures was used to estimate changes in PRO scores from baseline; scores were also compared with clinically meaningful change benchmarks.RESULTSThe analysis included 267 subjects, mean (SD) age 37.9 (14.7) years, 40.8% female; 55.1% grade 3 and 44.9% grade 4 Investigator Global Assessment for AD. Mean (SD) scores were: Worst Pruritus NRS 7.5 (1.9), Sleep Disturbance NRS 5.5 (2.9), DLQI total score 12.6 (7.1). Worst Pruritus and Sleep NRS scores had low positive correlations with SCORing AD (SCORAD) score (r = 0.44, r = 0.45 respectively) and negligible correlations with Eczema Area and Severity Index (EASI) score and area affected (r < 0.30). DLQI score varied by sex, study country, race, age, longer disease duration, disease severity (EASI and SCORAD), presence of asthma, and Worst Pruritus NRS, Sleep disturbance NRS, and DLQI scores. Rocatinlimab showed benefit on all three PROs, with significant improvements from baseline at the end of the double-blind period (week 18) and active treatment extension (week 36). Benefits were maintained over 20 weeks' post-treatment follow-up. The benefit of rocatinlimab treatment on PROs is rapid and maintained for at least 20 weeks following treatment completion.CONCLUSIONThis analysis demonstrates the importance of characterizing the burden of moderate-to-severe AD from the patient's perspective, alongside clinical disease measures, to develop a fuller picture of treatment benefit.TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT03703102.

News (Medical) associated with Rocatinlimab

14 Mar 2025

·www.prnewswire.com

Weekly Roundup: 15 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including business acquisition news from Sun Pharma and Labcorp as well as new research from the National Sleep Foundation. NEW YORK, March 14, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, March 10-14, 2025. Sun Pharma to Acquire Checkpoint Therapeutics "We are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC [metastatic cutaneous squamous cell carcinoma] patients in need of a differentiated immunotherapy treatment option," said James Oliviero, President and Chief Executive Officer of Checkpoint. Labcorp Announces Acquisition of Select Assets of BioReference Health's Innovative Oncology and Related Clinical Testing Services Businesses Labcorp will acquire BioReference Health's laboratory testing businesses focused on oncology and oncology-related clinical testing services across the United States. The assets that Labcorp will be acquiring currently generate approximately $85 million to $100 million in annual revenue. National Sleep Foundation Research Reveals Nearly 1/3 of Americans Diagnosed with Sleep Apnea are Not Receiving Treatment Despite Health Risks Findings revealed 78% of Americans aren't aware of all the treatment options available for sleep apnea and only 1 in 4 Americans can identify the health consequences of untreated sleep apnea. Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 Ignite Study in Adults with Moderate to Severe Atopic Dermatitis The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. Celebrating the Best in Patient Safety: Healthgrades Announces 2025 Top Hospitals for Patient Safety This year's recipients include 442 hospitals from 40 states and represent the top 10% of hospitals in the nation for patient safety. Patient safety is a vital component of achieving the best possible health outcomes, ensuring that serious injuries and complications are minimized for patients during hospital stays. U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases. Make-A-Wish Receives $250,000 Grant from U.S. Bank Foundation to Help Support Life-Changing Wishes Nationwide "Together with the U.S. Bank Foundation, we look forward to granting wishes that can replace fear with hope and transform the lives of wish kids and their families," said Leslie Motter, president and CEO of Make-A-Wish America. Health is Wealth: MyFitnessPal's Third Annual Nutrition IQ Survey Exposes Americans' Nutritional Blind Spots Amid Rising Food Prices While the new year traditionally inspires health-oriented resolutions, current economic pressures are adding a layer of complexity. Rising food prices further complicate efforts to prioritize nutrient-dense options in grocery carts, creating a substantial barrier for many. Clayman Thyroid Center Launches Inaugural Hashimoto's Disease Awareness Day on March 12 Hashimoto's Disease Awareness Day, to be observed annually on the second Wednesday in March, is designed to bring much-needed attention to Hashimoto's thyroiditis, an autoimmune condition that affects millions yet remains misunderstood, underdiagnosed, and often dismissed. The American Diabetes Association Announces the 2025 National Scientific and Health Care Achievement Award Winners "The diligent work of these passionate professionals is moving us closer to a world free of diabetes. Their contributions to research, prevention, and treatment are creating lasting change and improving the lives of people affected by diabetes," said Charles "Chuck" Henderson, the ADA's chief executive officer. Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. Informa Connect Celebrates Successful HIMSS25, Announces Dates for HIMSS26 The conference featured 600+ educational sessions, 950+ exhibitors, numerous networking opportunities and a highly attended hosted buyer program that facilitated crucial conversations about the future of healthcare technology and delivery models. Data Shows Quality of Life Improves for Spouses of Hip and Knee Replacement Patients When spouses were surveyed about their own quality of life compared to before their spouse's surgery, 70% said their quality of life was slightly or significantly better, 28% noted no change and 2% reported a slightly worse quality of life. Sesame Place Philadelphia Is First Theme Park in North America to Launch Hidden Disabilities Sunflower Program Part of a global initiative designed to support people with non-visible disabilities and conditions, the program consists of a wearable Sunflower-branded tool that discreetly signals to Sesame Place Ambassadors that a guest may need extra help, understanding, or time due to a disability or condition that may not be immediately apparent. Count Me In Launches New Patient-Partnered Research Project for Translocation Renal Cell Carcinoma tRCC is a unique type of kidney cancer caused by specific genetic changes called translocations, where parts of chromosomes s or rearrange. Due to its rarity, research on tRCC has historically been limited, leaving patients and families with few therapeutic options and many unanswered questions. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultAcquisitionPhase 3Drug Approval

14 Mar 2025

·www.echemi.com

2024 Revolution in Atopic Dermatitis Treatments with $14.179 Billion Sales

In 2024, Dupilumab has emerged as the "king of autoimmune drugs" with a staggering $14.179 billion in sales. Despite its approval for seven indications, its dominance is primarily rooted in atopic dermatitis (AD). As the pharmaceutical industry scrambles to innovate in this lucrative market, a wave of new AD therapeutics is on the horizon, all vying to dethrone Dupilumab. Among these contenders, OX40 inhibitors have captured attention due to their unique mechanism. By blocking upstream pathways involved in AD and reducing the production of memory T cells, they hold the potential for longer-lasting effects and extended dosing intervals. Early clinical results have further fueled market expectations. However, reality presents challenges. Recently, Amgen’s OX40 inhibitor, Rocatinlimab, achieved success in two Phase III trials, positioning it as the first OX40 monoclonal antibody likely to enter the market. Yet, despite its four-week dosing cycle advantage, it struggles to match the efficacy of Dupilumab and faces stiff competition from similar products. Currently, Rocatinlimab is viewed as a potential second-line treatment following Dupilumab, indicating that the anticipated AD revolution led by OX40 inhibitors may not yet disrupt the status quo. The true impact of these new therapies remains to be seen as additional clinical data emerges. This situation underscores that the race for innovation in the atopic dermatitis market is far from over. New entrants must navigate three critical hurdles: surpassing the clinical efficacy of existing therapies, optimizing patient adherence, and addressing safety concerns. The battle for this billion-dollar market is poised to reshape the innovation landscape in AD treatment. Even Dupilumab must remain vigilant.

Phase 3Clinical ResultDrug Approval

12 Mar 2025

·pmlive.com

Amgen/Kyowa Kirin share promising phase 3 results for rocatinlimab in atopic dermatitis

Amgen and Kyowa Kirin have shared promising results from a phase 3 programme of their investigational T-cell rebalancing therapy rocatinlimab in atopic dermatitis (AD). The 24-week IGNITE study, which met its co-primary endpoints and all key secondary endpoints, evaluated two doses of the candidate in more than 760 adults with moderate-to-severe AD, including those previously treated with a biologic or systemic Janus kinase inhibitor medication. At the end of the trial, 42.3% of patients receiving the higher dose of rocatinlimab achieved at least a 75% reduction from baseline in their Eczema Area and Severity Index score (EASI-75), representing a 29.5% difference against placebo. In the lower dose group, 36.3% of rocatinlimab-treated patients achieved EASI-75, a 23.4% difference versus placebo. Additionally, 23.6% of patients being treated with higher dose rocatinlimab and 19.1% of those in the lower dose group achieved a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of zero or one (clear or almost clear skin) with at least a two-point reduction from baseline at week 24, representing a 14.9% and 10.3% difference versus placebo, respectively. AD, the most common form of eczema, affects up to 20% of children and 10% of adults worldwide. The inflammatory disease causes excessively dry, itchy skin that can be painful, and patients with moderate-to-severe cases experience chronic symptoms and unpredictable flare-ups that can be painful and disruptive to everyday life. Rocatinlimab is designed to target the OX40 receptor, which is responsible for driving systemic and local inflammatory responses in AD and other conditions, including asthma and prurigo nodularis. Jay Bradner, executive vice president of research and development at Amgen, said: “Many patients with moderate-to-severe AD struggle with chronic, life-disrupting symptoms. Even with currently available therapies, they may fail to reach or maintain treatment goals. “We’re pleased with ROCKET programme results to date, which support the potential of rocatinlimab as a new treatment option.” The ROCKET programme is also informed by positive results from the SHUTTLE and VOYAGER studies, the companies said. The ASCEND trial will now investigate the effects of rocatinlimab beyond 24 weeks, and the ASTRO and ORBIT trials will evaluate the drug in adolescents. “These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells,” said Takeyoshi Yamashita, senior managing executive officer and chief medical officer at Kyowa Kirin.

Clinical ResultPhase 3Cell Therapy

100 Deals associated with Rocatinlimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 3	Argentina	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	United Kingdom	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	Australia	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	Hong Kong	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	United States	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	Canada	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	Turkey	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	Brazil	Amgen, Inc.	30 Jan 2023
Moderate Atopic Dermatitis	Phase 3	South Korea	Amgen, Inc.	30 Jan 2023
Dermatitis, Atopic	Phase 3	United States	Kyowa Kirin Co., Ltd.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05651711 (ROCKET HORIZON, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	726	Rocatinlimab	(gpyfdmojrj) = acfdkbpkwu nvidaswphm (yikahgisgj ) Met View more	Positive	25 Sep 2024
				Placebo	(gpyfdmojrj) = tzsawghhzo nvidaswphm (yikahgisgj ) Met View more
NCT05651711 (ROCKET HORIZON, Company_Website) Manual	Phase 3	Severe Atopic Dermatitis	726	Rocatinlimab	(ukmglanyac) = zawhhvrsnh ojwcigbhil (kixgdlwvlu ) Met View more	Positive	25 Sep 2024
				Placebo	(ukmglanyac) = olqnfoegwp ojwcigbhil (kixgdlwvlu ) Met View more
NCT03703102 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	274	KHK4083 (KHK4083 150 mg SC Q4W)	ggzeviwksq(qaodatppjg) = ppozstqtgm hfxnqojbmd (uqmsetcgzf, revswufcfu - umvchlwdxd) View more	-	09 Jun 2022
				KHK4083 (KHK4083 600 mg SC Q4W)	ggzeviwksq(qaodatppjg) = ospgprcdjh hfxnqojbmd (uqmsetcgzf, rplayxczqh - flkntdvdzp) View more
NCT02647866 (CTgov)	Phase 2	Abdominal Pain \| Colitis, Ulcerative	66	KHK4083 (KHK4083 Cohort 1)	qnrtjffqag(phnpmhxghl) = zsrfmvjhfy lmvlpdlpzm (fukwgslxof, ryiipvvrli - udyykzxkdm) View more	-	05 Mar 2020
				KHK4083 (KHK4083 Cohort 2)	qnrtjffqag(phnpmhxghl) = cmoousqruq lmvlpdlpzm (fukwgslxof, hrxnaxdqgf - qzkeaclmdt) View more

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