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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02068352




Registration number
NCT02068352
Ethics application status
Date submitted
19/02/2014
Date registered
21/02/2014

Titles & IDs
Public title
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Scientific title
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
Secondary ID [1] 0 0
2013-003899-12
Secondary ID [2] 0 0
271-12-205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OPA-15406
Treatment: Drugs - Vehicle ointment

Experimental: 0.3% OPA-15406 - OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.

Experimental: 1% OPA-15406 - OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.

Placebo comparator: Vehicle Ointment - OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.


Treatment: Drugs: OPA-15406
OPA-15406 topical ointment

Treatment: Drugs: Vehicle ointment
OPA-15406 1%-matching placebo topical ointment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)]
Timepoint [1] 0 0
Week 4
Secondary outcome [1] 0 0
Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
Timepoint [1] 0 0
Baseline, Week 4
Secondary outcome [2] 0 0
Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
Timepoint [2] 0 0
Baseline, Week 4
Secondary outcome [3] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [3] 0 0
From signing of informed consent through Week 8

Eligibility
Key inclusion criteria
* 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)
Minimum age
10 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/02/2015
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
- Phillip
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Woolloongabba
Recruitment hospital [4] 0 0
- Hectorville
Recruitment hospital [5] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
- Phillip
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
5073 - Hectorville
Recruitment postcode(s) [5] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Poland
State/province [15] 0 0
Katowice
Country [16] 0 0
Poland
State/province [16] 0 0
Krakow
Country [17] 0 0
Poland
State/province [17] 0 0
Lodz
Country [18] 0 0
Poland
State/province [18] 0 0
Warsaw
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinical-trials.otsuka.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02068352