Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Sponsor
Amgen
Study ID
NCT04804553
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Active Juvenile Psoriatic Arthritis

Eligibility Criteria

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

Interventions

  • Apremilast — DRUG
    Participants will receive apremilast orally.
  • Placebo — DRUG
    Participants will receive the matching placebo orally.

Study Details

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Key Dates

First listed
Mar 18, 2021
Start date
Mar 17, 2022
Status verified
Apr 2026
Primary completion
Mar 21, 2028
Completion
Dec 29, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
  • Placebo Comparator: Placebo to Apremilast
    Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.

Primary Outcome Measure

Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16 [ Time Frame: Baseline to Week 16 ]

Central Contacts