A Phase 2 interventional study of OPA-15406 and Vehicle ointment in Atopic Dermatitis, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 30 sites in 3 countries. Open to participants aged 10 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment
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).
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 121 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: OPA-15406
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Drug: OPA-15406
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.
Drug: Vehicle ointment
OPA-15406 topical ointment
OPA-15406 1%-matching placebo topical ointment
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.
Time frame: Week 4
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.
Time frame: Baseline, Week 4
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.
Time frame: Baseline, Week 4
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.
Time frame: From signing of informed consent through Week 8
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.
Time frame: Week 8
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.
Time frame: Baseline, Weeks 4 and 8
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.
Time frame: Baseline, Weeks 4 and 8
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.
Time frame: Baseline, Weeks 4 and 8
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.
Time frame: Baseline, Weeks 4 and 8
Participants took part in the study at 30 investigative sites in Australia, Poland, and the United States from 20 June 2014 to 28 January 2015.
| Milestone | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Started | 41 | 43 | 37 |
| Completed | 31 | 35 | 28 |
| Not completed | 10 | 8 | 9 |
| Withdrew: Lost to follow-up | 0 | 2 | 0 |
| Withdrew: Adverse event | 4 | 2 | 7 |
| Withdrew: Participant met (protocol specified) withdrawal criteria | 0 | 1 | 0 |
| Withdrew: Participant withdrew consent to participate | 6 | 3 | 1 |
| Withdrew: Protocol deviation | 0 | 0 | 1 |
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.
| percentage of participants | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Non-responders | 14.63 | 20.93 | 2.70 |
| LOCF | 15.00 | 20.93 | 2.70 |
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.
| score on a scale | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis] | -0.56 ± 0.14 | -0.55 ± 0.13 | -0.09 ± 0.15 |
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.
| score on a scale | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis] | -0.54 ± 0.15 | -0.54 ± 0.14 | -0.04 ± 0.15 |
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.
| percentage of participants | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Participants With Treatment Site AEs | 26.8 | 11.6 | 18.9 |
| Participants With Treatment-emergent AEs (TEAEs) | 58.5 | 41.9 | 54.1 |
| Participants With Serious TEAEs | 4.9 | 4.7 | 0.0 |
| Participants With Severe TEAEs | 12.2 | 4.7 | 8.1 |
| Participants With Severe Treatment Site TEAEs | 4.9 | 0.0 | 5.4 |
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.
| percentage of participants | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Non-responders | 17.07 | 16.28 | 10.81 |
| LOCF | 20.00 | 20.93 | 10.81 |
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.
| score on a scale | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Change at Week 4 | -2.21 ± 0.85 | -3.19 ± 0.80 | -1.10 ± 0.90 |
| Change at Week 8 | -2.60 ± 0.90 | -3.47 ± 0.86 | -1.57 ± 0.95 |
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.
| score on a scale | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Change at Week 4 | -2.00 ± 0.91 | -3.07 ± 0.87 | -0.51 ± 0.92 |
| Change at Week 8 | -2.42 ± 1.01 | -3.36 ± 0.96 | -1.00 ± 1.02 |
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.
| units on scale | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Change at Week 4 | -6.27 ± 4.67 | -16.71 ± 4.40 | -4.87 ± 4.96 |
| Change at Week 8 | -10.98 ± 5.12 | -20.71 ± 4.85 | -7.30 ± 5.44 |
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.
| units on a scale | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Change at Week 4 | -4.05 ± 4.92 | -14.59 ± 4.64 | -3.05 ± 4.96 |
| Change at Week 8 | -10.01 ± 5.51 | -20.33 ± 5.20 | -7.28 ± 5.56 |
Collected over From signing the informed consent until the end of the Treatment Period (Up to Week 8). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.3% OPA-15406 | 0/41 (0%) | 2/41 (4.9%) | 22/41 (53.7%) |
| 1% OPA-15406 | 0/43 (0%) | 2/43 (4.7%) | 13/43 (30.2%) |
| Vehicle Ointment | 0/37 (0%) | 0/37 (0%) | 16/37 (43.2%) |
| Event | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Liver function test abnormalInvestigations | 1/41 | 0/43 | 0/37 |
| Multiple sclerosisNervous system disorders | 1/41 | 0/43 | 0/37 |
| GiardiasisInfections and infestations | 0/41 | 1/43 | 0/37 |
| DepressionPsychiatric disorders | 0/41 | 1/43 | 0/37 |
| Event | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 11/41 | 7/43 | 8/37 |
| NasopharyngitisInfections and infestations | 3/41 | 1/43 | 3/37 |
| Upper respiratory tract infectionInfections and infestations | 3/41 | 1/43 | 0/37 |
| PruritusSkin and subcutaneous tissue disorders | 3/41 | 0/43 | 1/37 |
| HeadacheNervous system disorders | 2/41 | 3/43 | 0/37 |
| ToothacheGastrointestinal disorders | 0/41 | 1/43 | 2/37 |
| ExcoriationInjury, poisoning and procedural complications | 0/41 | 0/43 | 2/37 |
Efficacy Sample included all participants who were randomized and received at least one dose of investigational medicinal product (IMP).
| Age, Continuous(years) | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment | Total |
|---|---|---|---|---|
| Mean | 36.4 ± 15.2 | 34.1 ± 16.5 | 32.2 ± 15.6 | 34.3 ± 15.8 |
| Sex: Female, Male(Participants) | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment | Total |
|---|---|---|---|---|
| Female | 27 | 22 | 23 | 72 |
| Male | 14 | 21 | 14 | 49 |
| Ethnicity (NIH/OMB)(Participants) | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 7 | 18 |
| Not Hispanic or Latino | 37 | 36 | 30 | 103 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 2 | 3 |
| Black or African American | 14 | 11 | 5 | 30 |
| White | 24 | 30 | 28 | 82 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
Plan to share: Yes — 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 information: Study protocol, Sap, Csr
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Otsuka Pharmaceutical Development & Commercialization, Inc.