Clinical trial NCT05650320: To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects with Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis (AD)
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success rate in Investigator's Global Assessment at Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in Investigator's Global Assessment at Week 4
timeFrame: 4 weeks
measure: Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.
timeFrame: 4 weeks
measure: Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4.
timeFrame: 4 weeks
measure: Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4
timeFrame: 4 weeks
measure: Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4
timeFrame: 4 weeks
measure: Change from baseline in Verbal Rating Scale for Pruritus at Week 4
timeFrame: 4 weeks
measure: Change from baseline in Verbal Rating Scale for pruritus up to Day 7
timeFrame: 7 Days
measure: Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
timeFrame: 4 Weeks
measure: Change from baseline in the total affected Body Surface Area (percent) at Week 4
timeFrame: 4 weeks
measure: Success rate in Investigator's Global Assessment
timeFrame: 24 Weeks
measure: Time to Investigator's Global Assessment response
timeFrame: Within 24 Weeks
measure: Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index)
timeFrame: 24 Weeks
measure: Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index)
timeFrame: 24 Weeks
measure: Success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index)
timeFrame: 24 Weeks
measure: Change from baseline in Investigator's Global Assessment
timeFrame: 24 Weeks
measure: Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score
timeFrame: 24 Weeks
measure: Change from baseline in the total score of Patient-Oriented Eczema Measure
timeFrame: 24 Weeks
measure: Change from baseline in the total affected Body Surface Area (percent)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital
name: Lin Ma
role: PRINCIPAL_INVESTIGATOR
References: