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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Orbit 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 ≥ 12 to < 18 years at day 1
History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

ROCKET-Orbit Trial Summary

This trial tests a drug's safety and effectiveness in teens with moderate-to-severe eczema.

Who is the study for?
Adolescents aged 12 to under 18 with moderate-to-severe atopic dermatitis (AD) who haven't responded well to strong topical corticosteroids or when such treatments are not advised. Participants should have had AD for at least a year, an EASI score of ≥12, and more than 10% body surface area affected.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Rocatinlimab in adolescents with AD. It aims to see how well participants tolerate this medication and if it improves their skin condition compared to previous treatments they've tried.See study design
What are the potential side effects?
While specific side effects for Rocatinlimab in this trial aren't listed, common ones for new medications treating skin conditions like AD may include irritation at the injection site, headache, fatigue, nausea, or possible immune system reactions.

ROCKET-Orbit Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 17 years old.
Select...
My skin condition didn't improve with strong creams in the last 6 months.
Select...
At least 10% of my skin is affected by my condition.

ROCKET-Orbit Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-emergent Serious Adverse Events
Secondary outcome measures
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline and Presence of Barely Perceptible Erythema or No Erythema at Week 24
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
+1 more

ROCKET-Orbit Trial Design

1Treatment groups
Experimental Treatment
Group I: RocatinlimabExperimental Treatment1 Intervention
Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,381 Previous Clinical Trials
1,379,464 Total Patients Enrolled
MDStudy DirectorAmgen
927 Previous Clinical Trials
926,511 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05633355 — Phase 3
Atopic Dermatitis Research Study Groups: Rocatinlimab
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05633355 — Phase 3
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633355 — 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 welcome participants younger than 75 years old?

"The conditions for enrolment in the present trial necessitate that participants must be between 12 and 17 years old. Moreover, there are 104 clinical trials offered to minors and 170 studies open to elderly individuals over 65."

Answered by AI

What adverse effects have been reported as a result of taking Rocatinlimab?

"Our team has concluded that rocatinibimab is a safe intervention, awarding it the highest possible rating of 3. This determination was made based on prior evidence demonstrating its efficacy and numerous studies confirming its safety profile."

Answered by AI

How many venues are facilitating this research endeavor?

"Currently, prospective participants can register for this trial at 5 distinct sites across the US. These locations are in Portland, Corpus Christi and Dallas to name a few. To minimize travel costs associated with participating, it is best to select the clinic closest you."

Answered by AI

What is the size of the cohort enrolled in this clinical research?

"This research trial necessitates the enrolment of 170 suitable individuals. Potential participants can take part at either Oregon Medical Research Center in Portland or Driscoll Childrens Hospital located in Corpus Christi, Texas."

Answered by AI

Is there still room to enroll participants in this trial?

"Affirmative, according to the information hosted on clinicaltrials.gov this experiment is recruiting participants as of now. The trial was initially posted on January 30th 2023 and modified most recently on February 3rd 2023. It seeks 170 volunteers from 5 different medical centers."

Answered by AI

Is there a predetermined criteria for participation in this research?

"This clinical trial is selecting 170 juvenile patients with atopic dermatitis to participate. The selection criteria necessitates that candidates are between the ages of 12 and 17, have had diagnosis for a minimum 6 months, demonstrate inadequate response to topical corticosteroid therapy in combination or not with TCI's, an EASI score exceeding 16 points and vIGA-AD score above 3 as well as more than 10% BSA affected by AD at enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
2023. "A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633355.
All > Seborrheic Dermatitis > Atopic Dermatitis
~69 spots leftby Apr 2025
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