Rocatinlimab for Atopic Dermatitis/Eczema

(ROCKET-ASCEND Trial)

Recruiting in Palo Alto (17 mi)

+574 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Amgen

Disqualifiers: Permanent investigational product discontinuation, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing rocatinlimab to see if it is safe and can be tolerated by people with moderate-to-severe eczema. The medication works by calming the immune system to reduce skin inflammation and irritation.

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.

What data supports the effectiveness of the drug Rocatinlimab for treating atopic dermatitis?

While there is no direct data on Rocatinlimab, similar treatments like abrocitinib and baricitinib, which are also used for atopic dermatitis, have shown effectiveness in reducing symptoms such as itch and skin inflammation. ^{1 2 3 4 5}

Is rocatinlimab safe for humans?

Rocatinlimab, an anti-OX40 antibody, was tested in a clinical trial for atopic dermatitis and showed a safety profile that was evaluated alongside its effectiveness. The study was placebo-controlled, meaning some participants received a non-active treatment for comparison, which helps in assessing the safety of the drug. ^{6 7 8 9 10}

What makes the drug rocatinlimab unique for treating atopic dermatitis?

Rocatinlimab is unique because it targets the OX40-OX40L pathway, which is involved in the immune response that contributes to atopic dermatitis. This mechanism is different from other treatments that often target different pathways or use topical applications. ^{6 9 11 12 13}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Rocatinlimab (Monoclonal Antibodies)

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.

Participant Groups

Group I: 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 be assigned to receive OL Rocatinlimab Dose 1 Q4W.

Group II: 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 III: 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 IV: 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 V: 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

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England 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. [2023]

3. United States 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. [2022]

4. New Zealand 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. [2022]

5. New Zealand 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. [2023]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Infectious adverse events in patients with atopic dermatitis treated with baricitinib. [2023]

8. England 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. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. [2023]

10. England 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. [2021]

11. China 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. [2023]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]