Atopic Dermatitis Clinical Trial
— ROCKET-VOYAGEROfficial title:
A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
| Verified date | March 2024 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objectives of this study are to: - estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 - estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24
| Status | Active, not recruiting |
| Enrollment | 221 |
| Est. completion date | November 6, 2024 |
| Est. primary completion date | August 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 54 Years |
| Eligibility | Inclusion Criteria: - Age = 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months - History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors) - Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. - Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score = 3 Exclusion Criteria: - Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 - Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: - Systemic corticosteroids - Systemic immunosuppressants - Phototherapy - Janus kinase inhibitors - Treatment with any of the following medications or therapies within 1 week, prior to Day 1: - TCS of any potency - Topical calcineurin inhibitors (TCI) - Topical Phosphodiesterase-4 inhibitors (PDE4) - Other topical immunosuppressive agents - Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents - Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. - Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Skin Physicians Dermatology | Edmonton | Alberta |
| Canada | Kingsway Clinical Research | Etobicoke | Ontario |
| Canada | Guelph Dermatology Research | Guelph | Ontario |
| Canada | Interior Dermatology Centre | Kelowna | British Columbia |
| Canada | Clinique de Dermatologie Rosemont | Montreal | Quebec |
| Canada | Centre de Recherche Saint-Louis | Quebec | |
| Canada | York Dermatology Centre | Richmond Hill | Ontario |
| Canada | Karma Clinical Trials | Saint John's | Newfoundland and Labrador |
| Canada | Skincare Studio | St. John's | Newfoundland and Labrador |
| Canada | DermAtelier Clinical Research Incorporated | Toronto | Ontario |
| Canada | Evidence Based Medical Educator Inc | Toronto | Ontario |
| Canada | FACET Dermatology | Toronto | Ontario |
| Canada | Sima recherche | Verdun | Quebec |
| United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
| United States | Hamilton Research, LLC | Alpharetta | Georgia |
| United States | Divine Dermatology and Aesthetics | Atlanta | Georgia |
| United States | MetroDerm / Atlanta Center for Clinical Research, LLC | Atlanta | Georgia |
| United States | Oakland Hills Dermatology | Auburn Hills | Michigan |
| United States | Kern Research Inc | Bakersfield | California |
| United States | Cope Family Medicine | Bountiful | Utah |
| United States | The Derm Institute of West Michigan | Caledonia | Michigan |
| United States | Hope Clinical Research LLC | Canoga Park | California |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Epic Medical Research - Oklahoma | Chickasha | Oklahoma |
| United States | Doc1 Healthcare Systems | Chino | California |
| United States | Alliance for Multispecialty Research | Coral Gables | Florida |
| United States | Life Clinical Trials | Coral Springs | Florida |
| United States | AllerVie Clinical Research- Destin | Destin | Florida |
| United States | D and H Doral Research Centers | Doral | Florida |
| United States | Saint Jude Clinical Research | Doral | Florida |
| United States | First Georgia Physicians Group | Fayetteville | Georgia |
| United States | AllerVie Clinical Research- Glenn Dale | Glenn Dale | Maryland |
| United States | Cumberland Skin Center | Hermitage | Tennessee |
| United States | Direct Helpers Research Center | Hialeah | Florida |
| United States | Hickory Dermatology Research Center | Hickory | North Carolina |
| United States | Nexus Clinical Research | Homestead | Florida |
| United States | MedCare Pharma - Houston | Houston | Texas |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | 310 Clinical Research | Inglewood | California |
| United States | Forest Hills Dermatology Group | Kew Gardens | New York |
| United States | Chemidox Clinical Trials Incorporated | Lancaster | California |
| United States | Visage Dermatology and Aesthetic Center | Largo | Maryland |
| United States | Excel Clinical Research | Las Vegas | Nevada |
| United States | Dermatology and Skin Cancer Center Leawood | Leawood | Kansas |
| United States | Little Rock Allergy and Asthma Clinical Research Center | Little Rock | Arkansas |
| United States | Long Beach Research Institute | Long Beach | California |
| United States | University of California Los Angeles | Los Angeles | California |
| United States | Wallace Medical Group Inc | Los Angeles | California |
| United States | West Los Angeles Clinical Trials | Los Angeles | California |
| United States | Dermatologic Surgery Specialists | Macon | Georgia |
| United States | Tryon Medical Partners | Matthews | North Carolina |
| United States | Apex Clinical Research Center LLC | Mayfield Heights | Ohio |
| United States | Velocity Clinical Research Inc | Medford | Oregon |
| United States | sms Clinical Research Limited Liability Company | Mesquite | Texas |
| United States | ActivMed Practices and Research, LLC | Methuen | Massachusetts |
| United States | Anchor Medical Research | Miami | Florida |
| United States | D and H National Research Centers | Miami | Florida |
| United States | Gold Coast Health Research Center | Miami | Florida |
| United States | Meridian International Research | Miami Gardens | Florida |
| United States | Tanner Clinic | Murray | Utah |
| United States | Southern Indiana Clinical Trials | New Albany | Indiana |
| United States | Pioneer Clinical Research New York | New York | New York |
| United States | Las Vegas Clinical Trials | North Las Vegas | Nevada |
| United States | Northridge Clinical Trials | Northridge | California |
| United States | AllerVie Clinical Research- Ocala | Ocala | Florida |
| United States | Unity Clinical Research | Oklahoma City | Oklahoma |
| United States | Havana Research Institute Inc | Pasadena | California |
| United States | Oregon Dermatology and Research Center | Portland | Oregon |
| United States | Skin Cancer and Dermatology Institute | Reno | Nevada |
| United States | Rochester Clinical Research Inc | Rochester | New York |
| United States | Peninsula Research Associates | Rolling Hills Estates | California |
| United States | Integrative Skin Science and Research | Sacramento | California |
| United States | Wake Research Medical Center for Clinical Research | San Diego | California |
| United States | Wolverine Clinical Trials | Santa Ana | California |
| United States | Affiliated Dermatology | Scottsdale | Arizona |
| United States | Center for Dermatology and Plastic Surgery | Scottsdale | Arizona |
| United States | Scottsdale Clinical Trials | Scottsdale | Arizona |
| United States | Cura Clinical Research | Sherman Oaks | California |
| United States | Stryde Research - Epiphany Dermatology | Southlake | Texas |
| United States | Dermatologist of Central States Clinical Research - Springfield | Springfield | Ohio |
| United States | D and H Tamarac Research Centers | Tamarac | Florida |
| United States | Medical Advancement Centers of Arizona | Tempe | Arizona |
| United States | McIntosh Clinic PC | Thomasville | Georgia |
| United States | Dermatology Research Center of Oklahoma, PLLC | Tulsa | Oklahoma |
| United States | Tranquil Clinical Research | Webster | Texas |
| United States | The Skin Surgery Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with a Positive Anti-tetanus Response | Week 20 to week 24 | ||
| Primary | Number of Participants with a Positive Anti-meningococcal Response | Week 20 to week 24 |
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