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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05899816
Other study ID # 20210158
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 7, 2023
Est. completion date November 6, 2024

Study information

Verified date March 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rocatinlimab
Subcutaneous (SC) injection
Placebo
SC injection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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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