A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis
2 other identifiers
interventional
121
3 countries
30
Brief Summary
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedStudy Start
First participant enrolled
June 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2015
CompletedResults Posted
Study results publicly available
November 23, 2021
CompletedNovember 23, 2021
October 1, 2021
7 months
February 19, 2014
September 1, 2021
October 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score.
Week 4
Secondary Outcomes (3)
Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
Baseline, Week 4
Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
Baseline, Week 4
Percentage of Participants With Adverse Events (AEs)
From signing of informed consent through Week 8
Other Outcomes (5)
Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation)
Week 8
Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis)
Baseline, Weeks 4 and 8
Change From Baseline in EASI Score (Using LOCF Analysis)
Baseline, Weeks 4 and 8
- +2 more other outcomes
Study Arms (3)
0.3% OPA-15406
EXPERIMENTALOPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
1% OPA-15406
EXPERIMENTALOPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Vehicle Ointment
PLACEBO COMPARATOROPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants 10-70 years of age
- Diagnosis of AD
- History of AD for at least 3 years
- AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline
- Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)
You may not qualify if:
- Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
- Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Denver, Colorado, 80220, United States
Unknown Facility
Orange Park, Florida, 32065, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Arlington Heights, Illinois, 60005, United States
Unknown Facility
Carmel, Indiana, 46032, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Verona, New Jersey, 07044, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
Stony Brook, New York, 11790, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Portland, Oregon, 97239-4501, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
College Station, Texas, 77845, United States
Unknown Facility
Houston, Texas, 77065, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Phillip, Australian Capital Territory, Australia
Unknown Facility
Kogarah, New South Wales, Australia
Unknown Facility
Woolloongabba, Queensland, Australia
Unknown Facility
Hectorville, South Australia, 5073, Australia
Unknown Facility
Fremantle, Western Australia, Australia
Unknown Facility
Katowice, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 21, 2014
Study Start
June 20, 2014
Primary Completion
January 28, 2015
Study Completion
February 3, 2015
Last Updated
November 23, 2021
Results First Posted
November 23, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.