To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD

NCT ID: NCT05650320

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2025-01-15

Brief Summary

A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.

Detailed Description

1. Screening period is defined as the interval between the day of obtaining informed consent and the day of the baseline visit (0-30 days). The investigator performs a screening examination after obtaining informed consent from the subject's legal guardian (and, if possible, after obtaining consent from the subject).

2. Assessment period (4 weeks double blind treatment period) is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). Subjects who meet the inclusion criteria and do not meet the exclusion criteria at the baseline visit will be assigned to receive 0.3% or 1% OPA-15406 ointment or comparator (vehicle [Placebo]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of the Week 4 visit, a withdrawal visit will be performed for that subject.

3. Trial period(4 weeks double blind Treatment) The trial period for an individual subject is the period from the day of obtaining the written informed consent from the subject's legal guardian to the day of the Week 4 visit or withdrawal visit. For subjects who miss the Week 4 visit or withdrawal visit, the termination date, will be the date, as determined by the investigator, when the subject is withdrawn from the trial. The trial period does not include a follow-up period for AE.

4. 24 weeks, Open label, long term treatment period To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 0.3% or 1% OPA-15406 open treatment for up to 24 weeks based on the inform consent of the subjects.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.3% OPA-15406 Ointment

The 0.3% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Group Type: EXPERIMENTAL

0.3% OPA-15406 Ointment

Intervention Type: DRUG

Twice-daily administration for 4 weeks.

1% OPA-15406 Ointment

The 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Group Type: EXPERIMENTAL

1% OPA-15406 Ointment

Intervention Type: DRUG

Twice-daily administration for 4 weeks.

0% OPA-15406 Vehicle

The 0% formulation of OPA-15406 venicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Group Type: PLACEBO_COMPARATOR

0% OPA-15406 vehicle

Intervention Type: OTHER

Twice-daily administration for 4 weeks.

Interventions

0.3% OPA-15406 Ointment

Twice-daily administration for 4 weeks.

Intervention Type: DRUG

1% OPA-15406 Ointment

Twice-daily administration for 4 weeks.

Intervention Type: DRUG

0% OPA-15406 vehicle

Twice-daily administration for 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).

2. Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).

3. Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).

Exclusion Criteria

1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Ma

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital

Locations

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

271-403-00013

Identifier Type: -

Identifier Source: org_study_id