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 |
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| 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 |
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| Overall Contact |
Last Name: Drug Information Center Phone: +81-3-6361-7314 |
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| Location |
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| 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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