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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Ignite 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
Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
Must not have
Have you ever used topical steroid creams (i.e hydrocortisone)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights

ROCKET-Ignite Trial Summary

This trial will study how well the medication AMG 451 works by itself to treat patients, as well as how safe it is.

Who is the study for?
Adults with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to strong topical corticosteroids, or creams that suppress the immune system, may qualify. They should have a significant area of their body affected and experience intense itching. Those recently treated with biologics, systemic steroids, other immunosuppressants, phototherapy or certain inhibitors can't participate.Check my eligibility
What is being tested?
The trial is testing Rocatinlimab's effectiveness and safety as a standalone treatment for eczema compared to a placebo. Participants will be randomly assigned to receive either Rocatinlimab or an inactive substance without knowing which one they are receiving.See study design
What are the potential side effects?
Potential side effects of Rocatinlimab could include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, and possible effects on liver enzymes. The exact side effects will be monitored throughout the study.

ROCKET-Ignite Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have been diagnosed with atopic dermatitis for at least a year.
Select...
My skin condition didn't improve after using strong creams or ointments in the last 6 months.
Select...
Your Eczema Area and Severity Index (EASI) score is 16 or higher.
Select...
Your vIGA-AD score is 3 or higher.
Select...
At least 10% of my skin is affected by my condition.
Select...
I often feel itchy, rating my itchiness at least 4 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

ROCKET-Ignite Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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 a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24
Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24
Secondary outcome measures
Achievement of Facial AD Severity Score of Clear at week 24 for subjects with facial AD at baseline
Achievement of Genital AD Severity Score of Clear at week 24 for subjects with genital AD at baseline
Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8
+22 more

ROCKET-Ignite Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment1 Intervention
Rocatinlimab Dose 2 Q4W + loading dose at Week 2
Group II: Arm AExperimental Treatment1 Intervention
Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2
Group III: Arm CPlacebo Group1 Intervention
Placebo Q4W+ loading dose at Week 2

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,362 Previous Clinical Trials
1,384,571 Total Patients Enrolled
MDStudy DirectorAmgen
904 Previous Clinical Trials
922,066 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05398445 — Phase 3
Atopic Dermatitis Research Study Groups: Arm A, Arm B, Arm C
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05398445 — Phase 3
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398445 — Phase 3

Frequently Asked Questions

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

Will those over the age of sixty be able to participate in this experiment?

"This study includes a wider age range of patients than most, from 18 to 100 years old. In contrast, there are 110 trials that only include patients under the age of 18 and 181 for people over 65."

Answered by AI

In total, how many medical practices are participating in this research project?

"Currently, there are 8 active sites for this trial. For example, Genesis Clinical Research LLC is located in Tampa while Jubilee Clinical Research Inc can be found in Las Vegas. There are also other centresDermatology Research Center of Oklahoma, PLLC (Tulsa) and 7 more."

Answered by AI

Has the food and drug administration cleared AMG 451 for public consumption?

"AMG 451 is in Phase 3 clinical trials, thus there is evidence of its efficacy and safety from multiple rounds of testing. Consequently, Power rates AMG451's safety as a 3."

Answered by AI

Who else is applying?

What site did they apply to?
Dermatology Research Associates
Long Beach Research Institute, LLC
Jubilee Clinical Research Inc
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Probe trimasiclone y otros en pastillas no funciona.
PatientReceived 2+ prior treatments
~203 spots leftby Jan 2025