A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT06088199
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.

Key Dates

First listed
Oct 18, 2023
Start date
Oct 24, 2023
Status verified
Oct 2025
Primary completion
Aug 6, 2026
Completion
Aug 6, 2026

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events [ Time Frame: Day 1 up to approximately 285 days ]

Locations (30)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Affiliated DermatologyScottsdaleArizona85255-
Clear DermatologyScottsdaleArizona85255-
Johnson Dermatology ClinicFort SmithArkansas72916-
Avance Clinical TrialsLaguna NiguelCalifornia92677-
University of California IrvineOrangeCalifornia92868-
MedDerm AssociatesSan DiegoCalifornia92103-
Clinical Science InstituteSanta MonicaCalifornia90404-
California Dermatology InstituteThousand OaksCalifornia91320-
Pediatric Skin Research LLCCoral GablesFlorida33146-
Ciocca DermatologyMiamiFlorida33173-
University of South FloridaTampaFlorida33612-
Endeavor Health Clinical Trials CenterSkokieIllinois60077-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
Southern Indiana Clinical TrialsNew AlbanyIndiana47150-
Great Lakes Research Group Inc- SheffieldBay CityMichigan48706-
Henry Ford Medical Center - New Center OneDetroitMichigan48202-
Dermatology and Skin Cancer Center of Lees SummitLee's SummitMissouri64064-
Boeson ResearchMissoulaMontana59804-
Empire DermatologyEast SyracuseNew York13057-
State University of New York, Downstate Medical CenterManhassetNew York11030-
OptiSkin MedicalNew YorkNew York10029-
Hightower Clinical LLCOklahoma CityOklahoma73120-
Dermatology Research Center of Oklahoma, PLLCTulsaOklahoma74132-
Oregon Health and Science UniversityPortlandOregon97239-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Studies in Dermatology LLCCypressTexas77429-
Austin Institute for Clinical ResearchPflugervilleTexas78660-
Stride Clinical Research LLCSugar LandTexas77479-
Frontier Derm PartnersMill CreekWashington98012-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, ALAffiliated Dermatology· Scottsdale, AZClear Dermatology· Scottsdale, AZJohnson Dermatology Clinic· Fort Smith, ARAvance Clinical Trials· Laguna Niguel, CAUniversity of California Irvine· Orange, CA

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