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Monoclonal Antibodies

Rocatinlimab for Atopic Dermatitis (ROCKET-ASTRO Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent
Body weight ≥ 40 kg at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights

ROCKET-ASTRO Trial Summary

This trial tests a new drug to see if it's safe and effective for teens with certain medical conditions.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Possible side effects of Rocatinlimab may include reactions at the injection site, increased risk of infections, headaches, and potential effects on the immune system. The exact side effects are not listed but are being studied.

ROCKET-ASTRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with atopic dermatitis for over a year.
Select...
I weigh at least 40 kg.
Select...
My skin condition didn't improve with strong steroid creams.
Select...
Your EASI score is 12 or higher when first checked.
Select...
Your EASI score is 16 or higher on the first day of the study.
Select...
Your vIGA-AD score is 3 or higher.
Select...
Over 10% of my skin is affected by atopic dermatitis.
Select...
I have severe itching rated 4 or higher on a scale.

ROCKET-ASTRO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of EASI 75 at Week 24
Achievement of vIGA-AD 0/1 at Week 24
Secondary outcome measures
Achievement of EASI 75 at Week 16
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Subjects with Baseline HADS-depression Subscale Score ≥ 8
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Subjects with Baseline HADS-anxiety Subscale Score ≥ 8
+18 more

ROCKET-ASTRO Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D: Open-Label Dose 1Experimental Treatment1 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: PlaceboExperimental Treatment2 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 2Experimental Treatment1 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 1Experimental Treatment1 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,188 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,631 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05704738 — Phase 3
Atopic Dermatitis Research Study Groups: Arm A: Dose 1, Arm C: Placebo, Arm D: Open-Label Dose 1, Arm B: Dose 2
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05704738 — Phase 3
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704738 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accept seniors as participants?

"In line with the requirements of this research trial, only minors aged 12-17 are eligible for inclusion."

Answered by AI

Has Arm A: Dose 1 been endorsed by the Food and Drug Administration?

"Our experts at Power gave Arm A: Dose 1 a score of 3, as it has gone through multiple trials with evidence suggesting its safety and efficacy."

Answered by AI

Could I be enrolled in this clinical investigation?

"Eligible candidates for this research should be aged between 12 and 17 years old, having been diagnosed with atopic dermatitis. A total of 500 people may participate in the study."

Answered by AI

Are there any vacancies available for interested volunteers in this clinical trial?

"As indicated on clinicaltrials.gov, this study is not currently taking in any more subjects as it was last updated on January 20th 2023. It had initially been posted to the site back in February 3rd of the same year. However, 235 other trials are presently accepting patients so there may be alternate opportunities available for those seeking participation."

Answered by AI

In what quantity of healthcare facilities is this test taking place?

"Presently, 4 sites are hosting this medical trial. These locations include Plainfield, Boardman and Oklahoma City among others. To ease the burden of travel for patients, it is recommended that they choose the site nearest to their current residence."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Science Institute
The University of Texas Health Science Center at Houston
Essential Medical Research, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have been on several biological JAk inhibitors methotrexate and cyclosporine cellcept over the past 15 years..currently on Cibinqo 200mg OD.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Pioneer Clinical Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)
2023. "A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05704738.
All > Seborrheic Dermatitis > Atopic Dermatitis
~269 spots leftby Jun 2025
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