Rocatinlimab for Atopic Dermatitis

(ROCKET-VOYAGER Trial)

No longer recruiting at 94 trial locations

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

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

Disqualifiers: Live vaccines, Meningococcal vaccine, others

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

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called rocatinlimab for individuals with atopic dermatitis, a skin condition that causes itchy and inflamed patches. The researchers aim to evaluate the treatment's effectiveness compared to a placebo, focusing on its impact on responses to vaccines like tetanus and meningococcal. Participants will receive either rocatinlimab or a placebo every four weeks for 24 weeks. This trial targets adults who have had atopic dermatitis for at least a year and have not found success with strong topical steroid creams. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. There are specific timeframes for stopping different types of medications, such as biologics, systemic corticosteroids, and topical treatments, before starting the trial.

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

Research has shown that rocatinlimab is generally safe for people with atopic dermatitis. In one study, participants who used rocatinlimab for 24 weeks did not experience unexpected or severe side effects. Another study found that patients taking rocatinlimab improved more than those taking a placebo (a non-active substance).

While no treatment is completely without risk, current evidence suggests rocatinlimab is safe for the condition under study. It's important to remember that this treatment is still being tested to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atopic dermatitis?

Rocatinlimab is unique because it targets atopic dermatitis by modulating the immune system in a way that current treatments don't. Most treatments for atopic dermatitis, like topical corticosteroids and calcineurin inhibitors, focus on reducing inflammation directly. Rocatinlimab, however, is an experimental drug that aims to modify immune pathways involved in the chronic inflammation of this condition, potentially offering a new approach to managing symptoms. Researchers are excited about this because it could mean longer-lasting relief and fewer side effects compared to standard treatments.

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

Research has shown that rocatinlimab, which participants in this trial may receive, may help treat atopic dermatitis, a skin condition that causes itching and redness. In earlier studies, patients who took rocatinlimab showed noticeable improvements compared to those who took a placebo, a harmless pill with no active medicine. These improvements appeared in various parts of the body, including the sensitive areas of the head and neck. By week 16, patients demonstrated significant progress, and the benefits continued over time. This suggests that rocatinlimab could be a good option for people with moderate to severe atopic dermatitis. ^{1 2 3 5 6}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Adults aged 18-54 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to strong topical corticosteroids or other treatments. Participants should not have used biologics recently, nor received certain vaccines or immunosuppressive therapies within specific time frames before the trial.

Inclusion Criteria

I've had systemic treatment for AD but still qualify after a proper washout period.

Your skin condition, as assessed by the doctor, is rated as moderate or severe.

My skin condition didn't improve with strong creams or ointments.

Exclusion Criteria

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

I haven't had meningococcal or tetanus/diphtheria/pertussis vaccines recently.

I haven't taken any biologic medicines for the past 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

Treatment

Participants receive Rocatinlimab or placebo every 4 weeks for 24 weeks with a loading dose at Week 2

24 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 against a placebo to see if it affects how the body responds to tetanus and meningococcal vaccines. The effectiveness will be measured by comparing antibody responses in both groups after 24 weeks.

How Is the Trial Designed?

Group I: Rocatinlimab Experimental Treatment 1 Intervention

Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Group II: Placebo Placebo Group 1 Intervention

Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

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]

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]

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]

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]

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]

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. dermatologytimes.com dermatologytimes.com/view/rocatinlimab-maintains-safety-profile-in-24-week-ad-study

Rocatinlimab Maintains Safety Profile in 24-Week AD Study Rocatinlimab targets OX40R to rebalance T-cell activity, addressing unmet needs in atopic dermatitis treatment. The ROCKET-Ignite trial showed ...