A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis

Sponsors

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Source Otsuka Pharmaceutical Co., Ltd.
Brief Summary

To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

Overall Status Recruiting
Start Date 2022-05-01
Completion Date 2023-10-01
Primary Completion Date 2022-11-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Success rate in Investigator's Global Assessment (IGA) Week 4
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: OPA-15406

Description: 0.3% or 1% ointment, topical, twice daily, for 52 weeks

Arm Group Label: OPA-15406

Other Name: difamilast

Eligibility

Criteria:

Inclusion Criteria: - Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association - Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations - Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations Exclusion Criteria: -Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Gender:

All

Minimum Age:

3 Months

Maximum Age:

2 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Takehisa Matsumaru Study Director Otsuka Pharmaceutical Co., Ltd.
Overall Contact

Last Name: Drug Information Center

Phone: +81-3-6361-7314

Location
Facility: Status: Sotobo Children's Clinic
Location Countries

Japan

Verification Date

2022-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: OPA-15406

Type: Experimental

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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