An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT03777436
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Key Dates

First listed
Dec 17, 2018
Start date
Feb 11, 2019
Status verified
May 2024
Primary completion
Sep 23, 2021
Completion
Feb 9, 2022

Study Design

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

Arms

  • Experimental: Arm A- Apremilast with Placebo
    Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks
  • Experimental: Arm B - Apremilast 30 mg
    All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study

Primary Outcome Measure

Percentage of Participants With a Modified sPGA-G Response at Week 16 [ Time Frame: Baseline and Week 16 of the Placebo-controlled Phase ]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
First OC DermatologyFountain ValleyCalifornia92708-
Clinical Science InstituteSanta MonicaCalifornia90404-
Glick Skin InstituteMargateFlorida33073-
International Dermatology Research, IncMiamiFlorida33144-
Skin Care Physicians of GeorgiaMaconGeorgia31217-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
Adult and Pediatric DermatologyOverland ParkKansas66211-
ActivMed Practices and Research IncBeverlyMassachusetts01915-
Brigham and Womens HospitalBostonMassachusetts02115-
J Woodson Dermatology and AssociatesHendersonNevada89052-
Las Vegas DermatologyLas VegasNevada89144-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766-
ActivMedPortsmouthNew Hampshire03801-
Stony Brook Dermatology AssociatesStony BrookNew York11790-
Dermatology Consulting ServicesHigh PointNorth Carolina27262-
Oakview DermatologyAthensOhio45701-
Ohio State University Medical CenterGahannaOhio43230-
Oregon Health and Science UniversityPortlandOregon97239-
Paddington Testing Company IncPhiladelphiaPennsylvania19103-
Clinical Partners LLCJohnstonRhode Island02919-
Center for Clinical StudiesHoustonTexas77004-
Austin Institute for Clinical ResearchPflugervilleTexas78660-
Virginia Clinical Research IncNorfolkVirginia23502-
Bellevue Dermatology ClinicBellevueWashington98004-
Dermatology Center for Skin HealthMorgantownWest Virginia26505-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, ALFirst OC Dermatology· Fountain Valley, CAClinical Science Institute· Santa Monica, CAGlick Skin Institute· Margate, FLInternational Dermatology Research, Inc· Miami, FLSkin Care Physicians of Georgia· Macon, GA

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