Phase 2
Completed N=200
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02914548 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4 — 14.93; 22.39; 9.09 percentage of participants
Summary
The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4 |
14.93; 22.39; 9.09 | — |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Score |
-2.32; -3.16; -0.15 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score |
-6.76; -6.28; 0.90 | — |
| SECONDARY Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score |
-0.43; -0.49; -0.06 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score |
-1.36; -2.90; -0.02 | — |
| SECONDARY Change From Baseline in Percentage Affected Body Surface Area |
-3.94; -3.73; -0.32 | — |
| SECONDARY Mean (SD) OPA-15406 Plasma Trough Concentrations |
1.74; 4.96; 1.71; 5.22; 1.51; 5.52 | — |
| SECONDARY Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA |
0.114; 0.113; 0.104; 0.127; 0.0910; 0.137 | — |
| SECONDARY OPA-15406 Plasma PK Parameters, Cmax |
4.01; 7.27; 2.07; 10.4 | — |
| SECONDARY OPA-15406 Plasma PK Parameters, AUC8h |
22.0; 41.6; 11.6; 65.2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
Exclusion Criteria
- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- Subjects who have an active viral skin infection.
- Subjects with a current or history of malignancy.
Data sourced from ClinicalTrials.gov (NCT02914548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.