A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Part of paid clinical trials in Litchfield Park, Arizona.

Sponsor
Amgen
Study ID
NCT05651711
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Rocatinlimab — DRUG
    Rocatinlimab will be administered through a subcutaneous (SC) injection.
  • Placebo — OTHER
    The matching placebo will be administered through a SC injection.

Study Details

The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Key Dates

Start date
Dec 14, 2022
Status verified
Apr 2025
Primary completion
Jun 5, 2024
Completion
Aug 27, 2024

Study Design

Enrollment
726 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rocatinlimab
    Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
  • Placebo Comparator: Placebo
    Placebo Q4W for 24 weeks with a loading dose at Week 2.

Primary Outcome Measure

Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (69)

FacilityCityStateZIPSite coordinators
Research Solutions of Arizona, PCLitchfield ParkArizona85340-
Center for Dermatology and Plastic SurgeryScottsdaleArizona85260-
Clinical Trials Institute of Northwest ArkansasFayettevilleArkansas72703-
Burke Pharmaceutical ResearchHot SpringsArkansas71913-
Velocity Clinical Research Chula VistaChula VistaCalifornia91911-
West Coast Research LLCDublinCalifornia94568-
California Dermatology and Clinical Research InstituteEncinitasCalifornia92024-
Center for Dermatology Clinical Research IncFremontCalifornia94538-
Velocity Clinical Research - San DiegoLa MesaCalifornia91942-
Velocity Clinical Research - North HollywoodNorth HollywoodCalifornia91606-
Cura Clinical ResearchPalmdaleCalifornia93551-
University of California at San Francisco, Dermatology Clinic at Mount ZionSan FranciscoCalifornia94115-
Clinical Science InstituteSanta MonicaCalifornia90404-
Clarity DermatologyCastle RockColorado80109-
Velocity Clinical Research - DenverDenverColorado80209-
Foxhall Research CenterWashington D.C.District of Columbia20016-
Renaissance Research and Medical GroupCape CoralFlorida33991-
Driven Research LLCCoral GablesFlorida33134-
Saint Jude Clinical ResearchDoralFlorida33172-
Direct Helpers Research CenterHialeahFlorida33012-
Glick Skin InstituteMargateFlorida33063-
Miami Dade Medical Research Institute, LLCMiamiFlorida33176-
Innovation Medical Research Center IncPalmetto BayFlorida33157-
University of South Florida Health Morsani Center for Advanced HealthcareTampaFlorida33612-
Advanced Medical Research PCSandy SpringsGeorgia30328-
Sneeze, Wheeze, and Itch Associates, LLCNormalIllinois61761-
The South Bend Clinic LLPSouth BendIndiana46617-
Options Research Group LLCWest LafayetteIndiana47906-
Dermatology and Skin Cancer Center of Overland ParkOverland ParkKansas66223-
DS ResearchLouisvilleKentucky40241-
Kentucky Advanced Medical Research LLCMurrayKentucky42071-
MetroBoston Clinical PartnersBrightonMassachusetts02135-
Wendy Sadoff MD Dermatology PCFarmington HillsMichigan48334-
Revival Research Institute LLCTroyMichigan48084-
Somerset Skin CentreTroyMichigan48084-
Advanced Dermatology of the MidlandsOmahaNebraska68144-
James Del Rosso Dermatology ResearchLas VegasNevada89117-
Skin Cancer and Dermatology InstituteRenoNevada89509-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03766-
Weiss MedicalRiverdaleNew Jersey07457-
Corning Center For Clinical ResearchHorseheadsNew York14845-
Forest Hills Dermatology GroupKew GardensNew York11415-
Crystal Run HealthcareMonroeNew York10950-
Ace Clinical TrialsNew YorkNew York10022-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
OptiSkin MedicalNew YorkNew York10128-
Montefiore Medical CenterThe BronxNew York10467-
Duke South DurhamDurhamNorth Carolina27713-
Bernstein Clinical Research Center LLCCincinnatiOhio45236-
University of CincinnatiCincinnatiOhio45219-
The Ohio State University Dermatology EastGahannaOhio43230-
Velocity Clinical Research - Grants PassGrants PassOregon97527-
Oregon Medical Research CenterPortlandOregon97223-
Asthma and Allergy Physicians of Rhode Island Clinical Research InstituteWarwickRhode Island02886-
Bellaire Dermatology AssociatesBellaireTexas77401-
US Dermatology Partners Cedar ParkCedar ParkTexas78613-
Alina Clinical Trials, LLCDallasTexas75225-
Zenos Clinical Research, LLCDallasTexas75230-
MedCare Pharma - HoustonHoustonTexas77037-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
FMCScience LLCLampasasTexas76550-
Epic Clinical Research IncorporatedLewisvilleTexas75057-
Sienna Dermatology ResearchMissouri CityTexas77459-
Andante ResearchSan AntonioTexas78229-
Dermatology Clinical Research Center of San AntonioSan AntonioTexas78229-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
University of Utah MidValley DermatologyMurrayUtah84107-
Eastern Virginia Medical SchoolNorfolkVirginia23507-
MultiCare Institute for Research and InnovationSpokaneWashington99202-

Find similar trials in Litchfield Park, AZ

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Research Solutions of Arizona, PC· Litchfield Park, AZCenter for Dermatology and Plastic Surgery· Scottsdale, AZClinical Trials Institute of Northwest Arkansas· Fayetteville, ARBurke Pharmaceutical Research· Hot Springs, ARVelocity Clinical Research Chula Vista· Chula Vista, CAWest Coast Research LLC· Dublin, CA

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