Apremilast study in children with active oral ulcers associated with Behçet’s Disease

Phase 1

• Conditions: Subjects with active Behçet’s Disease; MedDRA version: 21.1Level: LLTClassification code 10004212Term: Behcet's diseaseSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002787-27-NL
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or Female subjects 2 to less than 18 years of age at randomization.
2. Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.
3. Oral ulcers that occurred more or equal to 3 times within the 12-month period prior to the screening visit.
4. Subject must have more or equal to 2 oral ulcers at both the screening visit and on day 1.
5. Subject has had prior treatment with = 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.
6. Subject is a candidate for systemic therapy for the treatment of oral ulcers.

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. Behçet’s disease-related active major organ involvement – pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and CNS (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:
- Previous major organ involvement is allowed if it occurred =1 year prior to the screening visit and is not active at time of enrollment;
-Subjects with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed;
- Subjects with BD-related arthritis and BD-skin manifestations are also allowed.
2. Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).
3. 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.
4. Female subject who is (or plans to become) pregnant or
breastfeeding.
5. 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