Rocatinlimab for Atopic Dermatitis

(ROCKET-ASTRO Trial)

Recruiting at 313 trial locations

Overseen By Amgen Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Biologics, Corticosteroids, Immunosuppressants, others

Disqualifiers: Biological treatment, Phototherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

532 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of rocatinlimab (also known as KHK4083 or AMG-451) for treating atopic dermatitis, a chronic skin condition that causes itchy and inflamed skin. Participants will receive different doses of the medication or a placebo to determine which works best, either alone or with other topical treatments. This study may suit teens aged 12 to 18 who have had atopic dermatitis for at least a year and haven't found success with certain creams or ointments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop using systemic corticosteroids, certain immunosuppressants, and some topical treatments for a specified period before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining the safety of rocatinlimab for individuals with atopic dermatitis, a condition that causes itchy and inflamed skin. Earlier studies have tested rocatinlimab on adults and teenagers with moderate-to-severe atopic dermatitis. These studies aim to assess treatment tolerance and potential side effects.

While long-term safety data remains limited, ongoing research continues to investigate this aspect. The advanced stage of the current study suggests some evidence that rocatinlimab is generally well-tolerated. However, participants in trials often experience some side effects, which researchers closely monitor to ensure safety. Prospective participants should discuss any concerns and possible side effects with the study team. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for atopic dermatitis?

Rocatinlimab is unique because it targets the OX40 receptor, a key player in the immune response involved in atopic dermatitis. Unlike standard treatments like topical corticosteroids and calcineurin inhibitors, which mainly address symptoms, Rocatinlimab directly influences the immune pathways that cause inflammation. Researchers are excited about this treatment because it offers a more targeted approach, potentially leading to longer-lasting relief and fewer side effects. Additionally, the possibility of adjusting dosing intervals could provide flexibility and improved patient outcomes over time.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research shows that rocatinlimab might be a promising treatment for atopic dermatitis, a skin condition causing itchy and inflamed patches. Participants in this trial will receive either rocatinlimab or a placebo. Earlier studies found that patients taking rocatinlimab improved more than those on a placebo. By Week 16, improvements were noticeable, especially in sensitive areas like the head and neck. The treatment provided lasting benefits across various body parts. This evidence suggests that rocatinlimab may effectively manage symptoms of moderate to severe atopic dermatitis. ^{2 4 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Adolescents aged 12-17 with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to certain creams and ointments can join. They must weigh at least 40 kg, have a significant area of their body affected, and experience notable itchiness. Those who've used strong medications or therapies for eczema in the month before the trial starts cannot participate.

Inclusion Criteria

Your vIGA-AD score is 3 or higher.

Over 10% of my skin is affected by atopic dermatitis.

I have severe itching rated 4 or higher on a scale.

Exclusion Criteria

I haven't used any strong skin medications or therapies in the last week.

I haven't taken steroids, immunosuppressants, had phototherapy, or used Janus kinase inhibitors recently.

I haven't taken any biological medicines for the last 12 weeks or 5 half-lives, whichever is longer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment Period

Participants receive Rocatinlimab or Placebo every 4 weeks for 24 weeks, with a loading dose at Week 2. Topical corticosteroids or calcineurin inhibitors may be used in combination therapy cohorts.

24 weeks

Maintenance Period

Part 1 Responders are rerandomized to continue Rocatinlimab or Placebo every 4 or 8 weeks for 28 weeks. Non-responders and relapsed participants receive open-label Rocatinlimab.

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Rocatinlimab

Trial Overview The study is testing Rocatinlimab's effectiveness and safety as a solo treatment or combined with other treatments for adolescents with severe skin inflammation due to eczema. Some participants will receive Rocatinlimab while others will get a placebo (a substance with no active drug).

How Is the Trial Designed?

Group I: Arm D: Open-Label Dose 1 Experimental Treatment 1 Intervention

Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.

Group II: Arm C: Placebo Experimental Treatment 2 Interventions

Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Group III: Arm B: Dose 2 Experimental Treatment 1 Intervention

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Group IV: Arm A: Dose 1 Experimental Treatment 1 Intervention

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

Ruxolitinib cream showed effective long-term disease control in atopic dermatitis, with 74.1% to 77.8% of patients achieving low disease severity scores after 52 weeks of treatment.

The cream was well-tolerated, with most adverse events being mild and unrelated to the treatment, suggesting a favorable safety profile and minimal systemic absorption of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. Papp, K., Szepietowski, JC., Kircik, L., et al.[2023]

In a phase 2b study involving 274 adults with moderate-to-severe atopic dermatitis, rocatinlimab significantly reduced Eczema Area and Severity Index (EASI) scores compared to placebo, with reductions of up to 61.1% observed at week 16 for the highest dose.

Rocatinlimab was generally well tolerated, with common side effects including pyrexia and nasopharyngitis, but no deaths were reported, indicating a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Guttman-Yassky, E., Simpson, EL., Reich, K., et al.[2023]

In a study involving 261,855 patients with atopic dermatitis (AD), the safety profile of Janus Kinase Inhibitors (JAK-Is) was assessed by comparing health outcomes to a rheumatoid arthritis (RA) cohort of 5,296 patients, revealing that the incidence rates of health outcomes in the AD cohort were 13-50% lower than in the RA cohort.

The findings suggest that while the absolute risks of health outcomes in the AD population are higher than in the general population, JAK-Is may still present a safer profile for AD patients compared to those with RA, indicating a need for further validation in similar populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. Montez-Rath, ME., Lubwama, R., Kapphahn, K., et al.[2022]

Abrocitinib, an oral Janus kinase 1 inhibitor, provided significant itch relief in patients with moderate-to-severe atopic dermatitis as early as day 4, outperforming both dupilumab and placebo in a phase III trial with adult patients.

Early improvement in itch relief (measured by the Peak Pruritus Numerical Rating Scale) at week 2 was predictive of better overall skin clearance and severity outcomes at week 12 for patients treated with abrocitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Ständer, S., Kwatra, SG., Silverberg, JI., et al.[2023]

Topical treatments like corticosteroids and calcineurin inhibitors, along with systemic options such as Janus kinase inhibitors and interleukin inhibitors, have shown significant efficacy in treating moderate-to-severe atopic dermatitis (AD).

The review compiles pivotal clinical trial data and real-world experiences to assess the safety and efficacy of these treatments, helping to guide optimal therapy choices for patients with AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated Review on Treatment of Atopic Dermatitis. Armario-Hita, JC., Galán-Gutiérrez, M., Dodero-Anillo, JM., et al.[2023]

In a phase 2a study involving 113 adults with moderate to severe atopic dermatitis, tezepelumab showed a numerically greater efficacy compared to placebo, with 64.7% of patients achieving a ≥50% reduction in eczema severity (EASI50) at week 12.

The safety profile of tezepelumab was comparable to placebo, with similar rates of treatment-emergent adverse events, suggesting it is a safe option for patients when combined with topical corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. Simpson, EL., Parnes, JR., She, D., et al.[2022]

Baricitinib, a JAK1/JAK2 inhibitor approved for moderate-to-severe atopic dermatitis, was studied in 2636 patients over a total exposure of 4628.4 patient years, showing a low discontinuation rate due to adverse events (3.4 incidents per 100 patient years).

The safety profile of baricitinib remained consistent with previous analyses, with serious adverse events and infections occurring at rates comparable to background levels in atopic dermatitis patients, indicating no new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 years and up to 3.9 years of treatment: an updated integrated analysis of eight clinical trials. Bieber, T., Katoh, N., Simpson, EL., et al.[2023]

Abrocitinib, a JAK1-selective inhibitor, has been shown to have a manageable long-term safety profile for treating moderate-to-severe atopic dermatitis, based on an analysis of 2856 patients over 1614 patient-years.

While some dose-related adverse events like nausea and headache were observed, serious infections and other severe complications were relatively low, indicating that with proper patient selection, abrocitinib can be safely used for extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Simpson, EL., Silverberg, JI., Nosbaum, A., et al.[2022]

Rocatinlimab and amlitelimab, two inhibitors targeting the OX40-OX40L pathway, showed significant efficacy in reducing atopic dermatitis symptoms in clinical trials, with rocatinlimab achieving a reduction of 48.3% to 61.1% in the EASI score compared to a placebo reduction of 15.0%.

Both treatments were found to be safe and well tolerated, with amlitelimab demonstrating a mean percentage change of 69.9% to 80.1% in EASI scores at week 16, indicating their potential as effective disease-modifying therapies for moderate-to-severe atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. Lé, AM., Torres, T.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40012373/

a phase 3 program evaluating the efficacy and safety of ... This is a large phase 3 program in AD that will provide important results on how well rocatinlimab works in adults and teenagers with moderate-to-severe AD.

2. amgen.com amgen.com/newsroom/press-releases/2025/09/amgen-and-kyowa-kirin-announce-top-line-results-from-rocatinlimab-phase-3-ascend-long-term-extension-study-in-adults-with-moderate-to-severe-atopic-dermatitis

Press Releases AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05651711

NCT05651711 | A Study Assessing Rocatinlimab (AMG ... Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39503757/

Durable improvements in atopic dermatitis in the head and ... Rocatinlimab treatment led to durable improvements in AD across multiple anatomic regions, including the sensitive head and neck region.

5. kyowakirin.com kyowakirin.com/media_center/news_releases/2022/pdf/e20221213_01.pdf

Kyowa Kirin Announces Lancet Publication of Phase 2b ... All treatment groups of patients treated with rocatinlimab achieved greater numerical improvement compared to placebo cohort at week 16 for most ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11901500/

ROCKET: a phase 3 program evaluating the efficacy and ... This is a large phase 3 program in AD that will provide important results on how well rocatinlimab works in adults and teenagers with moderate-to-severe AD.

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)01618-5/fulltext

Efficacy of rocatinlimab for moderate-to-severe atopic ... The authors also raised concerns over an absence of long-term safety data. Although not available in the main text of the Article, we provided ...

8. kyowakirin.com kyowakirin.com/media_center/news_releases/2024/pdf/e20240925_01.pdf

Kyowa Kirin Announces Top-line Data from Rocatinlimab ... ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab ...