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

Sponsor

Amgen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05767047

Collaborator

(none)

Enrollment

Arm

117.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the long-term safety of apremilast in participants 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.

Condition or Disease	Intervention/Treatment	Phase
Behçet's Disease Juvenile Psoriatic Arthritis	Drug: Apremilast	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Dec 31, 2032

Anticipated Study Completion Date :

Dec 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Apremilast Oral tablets or liquid suspension Other Names: AMG 407 Otezla CC-10004

Arm

Intervention/Treatment

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.

Drug: Apremilast

Oral tablets or liquid suspension

Other Names:

AMG 407

Otezla

CC-10004

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events [Up to approximately 4 years]
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Columbia-Suicide Severity rating Scale (C-SSRS) [Up to approximately 4 years]
A questionnaire used to assess suicide risk.
Tanner Staging [Up to approximately 4 years]
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Change from Baseline in Body Weight [Up to approximately 4 years]
Change from Baseline in Height [Up to approximately 4 years]
Change from Baseline in Body Mass Index (BMI) [Up to approximately 4 years]
Number of Participants with Clinically Significant Changes in Vital Signs [Up to approximately 4 years]
Number of Participants with Clinically Significant Changes in Laboratory Parameters [Up to approximately 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Informed consent / assent obtained
Must have completed Week 52 on treatment on core study
Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart)
Willing to adhere to study visit schedule and protocol requirements
Must have acceptable benefit/risk for continued treatment with apremilast

Exclusion Criteria:

Answer "yes" to any question on C-SSRS at Week 52 visit of core study
Scheduled surgery or other interventions that would interrupt study participation
Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
Female participants planning to become pregnant while on study through 30 days after last dose
Female participants of childbearing potential with positive pregnancy test at Week 0
Known sensitivity to any products to be administered during dosing
Not likely to be available to complete all protocol-required study visits