A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Sponsor
Amgen
Study ID
NCT05767047
Phase
PHASE3
Status
Recruiting
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Conditions

  • Behçet's Disease
  • Juvenile Psoriatic Arthritis

Eligibility Criteria

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

Interventions

  • Apremilast — DRUG
    Oral tablets or liquid suspension

Study Details

The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.

Key Dates

First listed
Mar 14, 2023
Start date
Mar 23, 2023
Status verified
Nov 2025
Primary completion
Mar 17, 2036
Completion
Mar 17, 2036

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Participants with a weight between ≥ 12 kg to \< 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to \< 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Up to approximately 4 years ]

Central Contacts

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