A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068352
• Other study ID #: 271-12-205
• Secondary ID: 2013-003899-12
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2014
• Est. completion date: February 3, 2015

Study information

• Verified date: October 2021
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 3, 2015
• Est. primary completion date: January 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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)

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• OPA-15406
OPA-15406 topical ointment
• Vehicle ointment
OPA-15406 1%-matching placebo topical ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation)	IGA evaluation was performed by a certified rater. The IGA 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. In the primary analysis, participants without IGA score available at Week 8 were treated as non-responders. In the sensitivity analysis, the missing IGA score at Week 8 was imputed using LOCF method first and the success was defined based on the imputed IGA score.	Week 8
Other	Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis)	The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score.	Baseline, Weeks 4 and 8
Other	Change From Baseline in EASI Score (Using LOCF Analysis)	The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score.	Baseline, Weeks 4 and 8
Other	Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus (Using MMRM Analysis)	At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas[s] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score.	Baseline, Weeks 4 and 8
Other	Change From Baseline in VAS for Pruritus (Using LOCF Analysis)	At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas[s] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score.	Baseline, Weeks 4 and 8
Primary	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	Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]	The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it 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. A negative change from Baseline indicates improvement in overall IGA score.	Baseline, Week 4
Secondary	Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]	The IGA allows for an assessment of overall disease severity at a given time point, and it 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. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score.	Baseline, Week 4
Secondary	Percentage of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event.	From signing of informed consent through Week 8