A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Public ClinicalTrials.gov record NCT05724199. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The coprimary objectives of the study are to: * evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). * evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
Study identification
- NCT ID
- NCT05724199
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 746 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 21, 2023 (Actual)
- Primary completion
- Sep 15, 2024 (Actual)
- Completion
- Dec 4, 2024 (Actual)
- Last update posted
- Aug 6, 2026
2023 – 2024
United States locations
- U.S. sites
- 45
- U.S. states
- 24
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | — |
| Southwest Skin Specialists | Phoenix | Arizona | 85018 | — |
| US Dermatology Partners Sun City West | Sun City West | Arizona | 85375 | — |
| Arkansas Research Trials, LLC | North Little Rock | Arkansas | 72117 | — |
| Kern Research Inc | Bakersfield | California | 93301 | — |
| Keck Medicine of University of Southern California | Los Angeles | California | 90033 | — |
| Wallace Medical Group Inc | Los Angeles | California | 90056 | — |
| Antelope Valley Clinical Trials | Palmdale | California | 93551 | — |
| University of California at Davis Medical Center | Sacramento | California | 95816 | — |
| Kaiser Permanente South Sacramento Medical Center | Sacramento | California | 95823 | — |
| Acclaim Clinical Research | San Diego | California | 92120 | — |
| Kaiser Permanente Medical Center - Oakland | San Francisco | California | 94118 | — |
| Kaiser Permanente Medical Center - San Francisco | San Francisco | California | 94118 | — |
| Synergy Dermatology | San Francisco | California | 94132 | — |
| TrueBlue Clinical Research | Tampa | Florida | 33609 | — |
| Olympian Clinical Research - Tampa | Tampa | Florida | 33615 | — |
| Atlanta Dermatology, Vein and Research Center, PC | Alpharetta | Georgia | 30022 | — |
| Divine Dermatology and Aesthetics | Atlanta | Georgia | 30315 | — |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | — |
| DS Research | Clarksville | Indiana | 47129 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | — |
| Dermatology and Skin Cancer Center Leawood | Leawood | Kansas | 66211 | — |
| Industrial Medicine Associates Clinical Research Advanced Dermatology Care | Monroe | Louisiana | 71201 | — |
| Aesthetic and Dermatology Center | Rockville | Maryland | 20850 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Oakland Hills Dermatology | Auburn Hills | Michigan | 48326 | — |
| Somnos Clinical Research | Lincoln | Nebraska | 68505 | — |
| Skin Specialists PC | Omaha | Nebraska | 68144 | — |
| Vivida Dermatology | Las Vegas | Nevada | 89119 | — |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | — |
| Schweiger Dermatology Group, PC Research Division | Hackensack | New Jersey | 07601 | — |
| Albuquerque Clinical Trials Incorporated | Albuquerque | New Mexico | 87102 | — |
| Chear Center LLC | The Bronx | New York | 10455 | — |
| Accellacare of Wilmington | Wilmington | North Carolina | 28401 | — |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | — |
| Velocity Clinical Research Inc | Medford | Oregon | 97504 | — |
| Paddington Testing Company Inc | Philadelphia | Pennsylvania | 19103 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| US Dermatology Partners Jollyville | Austin | Texas | 78759 | — |
| Newco 3A Research LLC | El Paso | Texas | 79925 | — |
| Sante Clinical Research | Kerrville | Texas | 78028 | — |
| Texas Dermatology Research Center | Plano | Texas | 75025 | — |
| Virginia Dermatology and Skin Cancer Center | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 189 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05724199, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05724199 live on ClinicalTrials.gov.