Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis

• Register: EUCTR
• Last refreshed on: 30 January 2023
• Main ID: EUCTR2022-003024-41-ES
• Date of registration: 25/11/2022
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis
• Scientific title: A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
• Date of first enrolment: 25/01/2023
• Target sample size: 48
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2022-003024-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Greece, Israel, Italy, Spain, Switzerland, Turkey, United Kingdom

Contacts

• Name: IHQ-Medical Info - Clinical Trials
• Affiliation: Amgen S.A.

• Name: IHQ-Medical Info - Clinical Trials
• Affiliation: Amgen S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject’s legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
2. Subject must have completed week 52 (Apremilast Active Treatment Phase) of Study 20190529 (from France and Turkey sites only) or Study 20190530 where drug is not commercially available in their country.
3. Subject must have an age and sex specific body mass index (BMI) value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart (Appendix 11.7) for children and adolescents (CDC, 2000) at randomization.
4. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
5. Subject must have acceptable benefit/risk for continued treatment with apremilast.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Answer “Yes” to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the week 52 visit on Study 20190529 (subjects from France and Turkey sites only) or Study 20190530.
2. Scheduled surgery or other interventions that would interrupt the subject’s participation in the study.
3. Female subjects of childbearing potential (for the purpose of this study, a female subject is considered of childbearing potential if she is 12 years old or older or has reached menarche, whichever occurred first) unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 30 days after the last dose of investigational product.
4. Female subjects planning to become pregnant while on study through 30 days after the last dose of investigational product.
5. Female subjects of childbearing potential with a positive pregnancy test assessed at week 0 by a highly sensitive urine or serum pregnancy test.
6. Subject has known sensitivity to any of the products to be administered during dosing.
7. Subject likely to not be available to complete all protocol-required study visits.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis
MedDRA version: 21.1 Level: LLT Classification code 10004212 Term: Behcet's disease System Organ Class: 100000004866
MedDRA version: 20.0 Level: LLT Classification code 10079454 Term: Systemic juvenile idiopathic arthritis System Organ Class: 100000004859

Intervention(s)

Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG 407
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: AMG 407
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG 407
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: AMG 407
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Product Name: Apremilast
Product Code: AMG 407
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: AMG 407
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: 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 JPsA that have completed Study 20190530 or Study 20190529

Primary end point(s): - Adverse events: Type, frequency, severity, and relationship to apremilast
- Columbia-Suicide Severity rating Scale (C-SSRS)
- Tanner Staging
- Body weight, height, and body mass index (BMI)
- Vital signs and laboratory parameters

Timepoint(s) of evaluation of this end point: week 0, 26 , 52, 78, 104, 130 , 156 , 182 , 208 and 212

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

20190531

Source(s) of Monetary Support

Amgen Inc.

Ethics review

Status: Approved
Approval date: 24/01/2023
Contact: