To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to

Status Recruiting

Clinical Trial Summary

This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.

Clinical Trial Description

1. Screening period After obtaining informed consent, the investigator will perform a screening examination. The screening period is defined as the period between the day of obtaining informed consent and the day of baseline visit (0 - 30 days). 2. Assessment period (4 weeks double blind treatment period) The assessment 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). The subject who meets the inclusion criteria and does not meet the exclusion criteria at the baseline visit will be allocated to the 1% formulation of OPA-15406 or the 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, the 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 Week 4 visit, a withdrawal visit will be performed for that subject. 3. 4 Weeks Double Blind The trial period for individual subject is the period from the day of obtaining the subject's written informed consent to the day of the Week 4 visit or withdrawal visit. For subjects who missed the Week 4 visit or withdrawal visit, the day of discontinuation will be the day when the investigator determined that the subject was to be withdrawn from the trial. It does not include the follow-up period for AE.To evaluate the efficacy (secondary endpoint) and safety of IMP (1% OPA-15406 ointment) when administered twice-daily for 4 weeks in adult patients with AD. 4. 24 Weeks Open label, long term treatment period (China only) 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 1% OPA-15406 open treatment for up to 24 weeks based on the informed consent of the subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05667623
Study type	Interventional
Source	Otsuka Beijing Research Institute
Contact	Hanhan Wang
Phone	13810583289
Email	wanghanhan@cn.otsuka.com
Status	Recruiting
Phase	Phase 3
Start date	February 6, 2023
Completion date	January 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms