Apremilast Study in Children with Active Juvenile Psoriatic Arthritis

Phase 1

• Conditions: Juvenile psoriatic arthritis; MedDRA version: 20.0Level: LLTClassification code 10079454Term: Systemic juvenile idiopathic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002788-88-GR
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or Female subjects 5 to less than 18 years of age at the time of randomization.
2. Confirmed diagnosis of JPsA according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:
-Arthritis and psoriasis, OR
-Arthritis with at least 2 of the following:
-Dactylitis
-Nail pitting or onycholysis
- Psoriasis in a first-degree relative
3. Active disease: at least 3 active joints (including distal interphalangeal joints).
4. Inadequate response (at least 2 months) or intolerance to = 1 DMARD, (which may include MTX or biologic agents).

Other protocol-defined inclusion criteria apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
- Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
- Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, - Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
- History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
- Presence of systemic JIA.
2. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
3. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
4. History or evidence of any other clinically significant disorder, condition or disease that could pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
5. Female subject who is (or plans to become) pregnant or breastfeeding.
6. Female subject of childbearing potential unwilling to use 1 highly effective method of contraception.

Other protocol-defined exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified