Rocatinlimab for Atopic Dermatitis/Eczema

(ROCKET-ASCEND Trial)

Not currently recruiting at 738 trial locations

Overseen By Amgen Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Permanent investigational product discontinuation, 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: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of rocatinlimab, an experimental treatment for people with moderate-to-severe atopic dermatitis (eczema). The study includes different groups, with some receiving various doses of the treatment and others receiving a placebo, a harmless pill that resembles the treatment but has no effect. Participants who previously joined a rocatinlimab study and completed a specific treatment period might qualify for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants a chance to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that rocatinlimab is under study for safety in people with moderate-to-severe atopic dermatitis, also known as eczema. In earlier studies, many participants have already tried rocatinlimab to assess its tolerability. These studies help identify any side effects and their frequency.

So far, trials have not found major safety issues. However, mild to moderate side effects may occur, which is common with many treatments. The current trial focuses on long-term safety, so researchers continue to learn about rocatinlimab's effects over time.

For those considering joining a trial, it's helpful to know that rocatinlimab has undergone extensive testing. While this can be reassuring, individual experiences may vary. Always consult with the trial team or a doctor to understand what participation might mean. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Rocatinlimab is unique because it offers a novel approach to treating atopic dermatitis, or eczema, by targeting the immune system differently than current options like topical steroids and calcineurin inhibitors. Most treatments aim to reduce inflammation directly, but Rocatinlimab works by modulating the immune response, potentially leading to more durable improvements. Researchers are excited because this mechanism could provide longer-lasting relief and help manage severe cases that don't respond well to existing therapies.

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

Research shows that rocatinlimab offers promising results for people with moderate-to-severe atopic dermatitis, also known as eczema. A previous study found that it significantly reduced disease severity compared to a placebo, providing patients with noticeable symptom relief. Another study found that serious side effects were rare and similar to those in the placebo group. In this trial, participants will join various treatment arms, including different doses of rocatinlimab and placebo. These findings suggest that rocatinlimab could effectively manage eczema symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults and adolescents with moderate-to-severe atopic dermatitis (AD), commonly known as eczema, who have completed a previous rocatinlimab study within the last 28 days. It's not open to those who had to stop taking the drug due to safety concerns or other rules from earlier studies.

Inclusion Criteria

You have finished the final study visit for a previous study involving the drug rocatinlimab within the last 28 days.

Exclusion Criteria

I was removed from a previous study due to safety concerns or other specific reasons.

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 or 8 weeks based on their previous study assignment

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive open-label Rocatinlimab Dose 1 every 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rocatinlimab

Trial Overview

The trial is testing the long-term effects of a medication called Rocatinlimab on AD. Participants will either continue receiving Rocatinlimab or be given a placebo, which has no active ingredients, to compare outcomes over time.

How Is the Trial Designed?

Group I: ARM G Group Experimental Treatment 1 Intervention

Participants from Arm F who meet defined criteria will resume OL Rocatinlimab Dose 1 Q4W.

Group II: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 Experimental Treatment 1 Intervention

Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab study ROCKET-Orbit will continue to receive OL Rocatinlimab Dose 1 Q4W.

Group III: ARM B: Dose 2 to Dose 2 Experimental Treatment 1 Intervention

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.

Group IV: ARM A: Dose 1 to Dose 1 Experimental Treatment 1 Intervention

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.

Group V: ARM F Group Active Control 1 Intervention

Participants in Arm E (OL Rocatinlimab Dose 1 Q4W) who meet defined criteria will have Rocatinlimab withdrawn, but will continue all subsequent study visits.

Group VI: ARM D: Placebo to Placebo Placebo Group 1 Intervention

Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.

Group VII: ARM C: Dose 1 or Dose 2 to Placebo Placebo Group 1 Intervention

Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.

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

Baricitinib, a JAK1-2 inhibitor approved for moderate-to-severe atopic dermatitis, has a safety profile where infections are the most common side effects, primarily mild-to-moderate cases like upper respiratory infections and herpes simplex exacerbations.

The analysis included data from eight clinical trials, highlighting the need for more real-world data to better understand which patients may benefit most from baricitinib treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious adverse events in patients with atopic dermatitis treated with baricitinib. Antonelli, F., Malvaso, D., Caldarola, G., et al.[2023]

Ruxolitinib cream 1.5% significantly improved disease severity, itching, and sleep disturbance in patients aged 12 and older with mild to moderate atopic dermatitis after 8 weeks of treatment, and continued to control symptoms for an additional 44 weeks when applied as needed.

The cream was well tolerated, with a safety profile similar to that of a placebo, and infrequent local side effects, making it a promising alternative to traditional treatments like corticosteroids for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. Hoy, SM.[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]

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]

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]

The TREAT Registry Taskforce is launching a long-term safety study to compare the safety of dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema, focusing on the incidence of malignancies and other serious adverse events.

This study will utilize a standardized approach across multiple national registries, providing valuable safety data that can inform regulatory bodies, clinicians, and pharmaceutical companies about the long-term risks associated with these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. Bosma, AL., Spuls, PI., Garcia-Doval, I., et al.[2021]

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]

Baricitinib, an oral medication for moderate-to-severe atopic dermatitis, showed significant improvements in skin severity scores (EASI and SCORAD) as early as week 1 for monotherapy and week 2 for combination therapy, with effects lasting up to 16 weeks.

Patients treated with baricitinib experienced rapid and sustained improvements in quality of life, suggesting that these improvements may exceed what is reflected in traditional severity scores, indicating a potential disconnect between clinical assessments and patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis. Thyssen, JP., Bieber, T., Kleyn, CE., 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]

In a phase 2b trial involving 120 adults with moderate-to-severe atopic dermatitis, CM310 significantly improved skin condition, with 70% of high-dose and 65% of low-dose patients achieving at least a 75% improvement in their Eczema Area and Severity Index score compared to only 20% in the placebo group.

CM310 was well-tolerated, with a similar incidence of treatment-emergent adverse events across all groups, and no severe adverse events linked to the treatment, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial. Zhao, Y., Zhang, J., Yang, B., et al.[2023]

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]

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]

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]

Citations

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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.

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

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Rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo.

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

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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 ...

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