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Monoclonal Antibodies

Rocatinlimab for Atopic Dermatitis (ROCKET-SHUTTLE 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights

ROCKET-SHUTTLE Trial Summary

This trial will assess the effectiveness of a new drug for atopic dermatitis, compared to placebo, at 24 weeks.

Who is the study for?
Adults over 18 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to strong topical corticosteroids. They should have an EASI score of 16 or more, AD covering at least 10% of their body, and significant itchiness. Those recently treated with biologics, systemic steroids or immunosuppressants, phototherapy, Janus kinase inhibitors or certain topicals can't participate.Check my eligibility
What is being tested?
The trial is testing Rocatinlimab's effectiveness in combination with standard skin treatments against a placebo mix. It measures improvements in skin condition and severity after 24 weeks using two scales: the vIGA-AD™ for visual assessment and the Eczema Area and Severity Index (EASI).See study design
What are the potential side effects?
Rocatinlimab may cause injection site reactions, headaches, cold-like symptoms (upper respiratory infections), fatigue, and possibly allergic reactions. Topical treatments might lead to skin irritation or thinning if used long-term.

ROCKET-SHUTTLE 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 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
Secondary outcome measures
Achievement of EASI 75 at Week 16
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
+25 more

ROCKET-SHUTTLE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Rocatinlimab Dose 2 + TCS/TCIExperimental Treatment1 Intervention
Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
Group II: Rocatinlimab Dose 1 + TCS/TCIExperimental Treatment1 Intervention
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.
Group III: Placebo + TCS/TCIPlacebo Group1 Intervention
Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,391 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
923,864 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05724199 — Phase 3
Atopic Dermatitis Research Study Groups: Rocatinlimab Dose 2 + TCS/TCI, Placebo + TCS/TCI, Rocatinlimab Dose 1 + TCS/TCI
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05724199 — Phase 3
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724199 — Phase 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05724199 — 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 encompass geriatric patients?

"The minimum age of enrolment for this medical study is 18 years old, and the upper cap is 100."

Answered by AI

What has been observed about the safety of administering Rocatinlimab Dose 2 + TCS/TCI to people?

"Our team at Power has evaluated the safety of Rocatinlimab Dose 2 + TCS/TCI to be a 3 due to multiple rounds of clinical trials affirming efficacy and security."

Answered by AI

Is this study currently accepting participants?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial is actively enrolling participants, having been originally posted on February 21st 2023 and lastly updated in March 1st of the same year. This study requires 715 patients to be recruited from 19 different medical centres."

Answered by AI

How many individuals have enrolled in this clinical experiment?

"This clinical trial requires 715 eligible participants and is accepting enrolment from Southwest Skin Specialists in Sun City West, Arkansas as well as US Dermatology Partners Sun City West in North Little Rock, California."

Answered by AI

Are there multiple venues administering this clinical investigation across the state?

"Currently, 19 medical sites are welcoming participants to join this trial. These locations range from Sun City West and North Little Rock to Palmdale and beyond. Choosing the closest clinic is advised in order to reduce travel costs associated with enrollment."

Answered by AI

Is there an eligibility criterion for participants to join this medical trial?

"This clinical trial seeks to enrol 715 people (aged 18-100) with a confirmed diagnosis of atopic dermatitis according to the American Academy of Dermatology's criteria. Eligible candidates must have an EASI score ≥16, vIGA-AD score ≥3, 10% BSA involvement and Worst pruritus numerical rating scale ≥ 4. Moreover, they need to demonstrate inadequate response to TCS or TCI within 6 months prior joining this study."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
What site did they apply to?
CHEAR Center LLC
Somnos Clinical Research
Sante Clinical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+

What questions have other patients asked about this trial?

Hi, I would like to know if travel expenses are included? What is the pay for this trial. Can I be helped?
PatientReceived no prior treatments

Why did patients apply to this trial?

i have a eczema on face and would hope to fund treatment.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
2023. "A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724199.
All > Seborrheic Dermatitis > Atopic Dermatitis
~188 spots leftby Oct 2024
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