NCT05667623.
| Study name | A comparison trial to demonstrate the superiority of 1% OPA‐15406 ointment to the vehicle in adult AD subjects |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT05667623 Country: China, Korea (not reported if North or South) Outpatient or hospital: not reported Date trial conducted: not reported Duration of trial participation: 4 weeks Inclusion criteria: · Outpatient · 15 to 70 years old, male or female · AD according to Hanifin and Rajka criteria · History of AD for at least 3 years · AD affecting ≥ 5% to ≤ 40% of BSA (excluding scalp) · IGA score of 2 or 3 Exclusion criteria: · Pregnant, possibly pregnant, or breastfeeding, who desire to become pregnant or to have their partner become pregnant during the trial period and up until 30 days after the final administration of IMP, or who are unable to either remain abstinent or employ at least two specified birth control methods · AD or contact dermatitis rapid deterioration within 28 days · Concurrent or history of skin disease other than AD and who are judged inappropriate for assessment of AD in the present trial · Active viral skin infection or clinical signs of such infection · A current/history of malignancy within the previous 5 years · A current/history of recurrent bacterial infection resulting in hospitalisation or requiring intravenous antibiotic treatment within the past 2 years · Clinically significant complication or history of any serious disorders that the investigator judges would prevent safe conduct of the trial or impact efficacy assessment of the IMP, for example cardiac disease, endocrinologic disease, pulmonary disease · Any abnormal haematology or serum chemistry results at screening visit · Judged by the investigator to have a clinically significant abnormal blood pressure or pulse rate at the screening and baseline visits · Unable to stop allergen immunotherapy (or desensitisation therapy) from 3 months · Unable to stop treatment with ultraviolet A, narrowband ultraviolet B, and ultraviolet B from 28 days prior to the baseline examination or to stop using systemic corticosteroids, systemic immunosuppressants, systemic antimetabolites, systemic retinoid, and biologics from 28 days prior to the baseline visit · Unable to stop using topical corticosteroids for skin (excluding scalp) categorised as very strong potency from 21 days prior to the baseline visit · Unable to stop using topical corticosteroids for skin (excluding scalp) categorised as strong potency 7 days prior to the baseline visit. However, intra‐ocular, intra‐nasal, intra‐auricular, and inhaled corticosteroids may be considered if the investigator judges that their use will not impact assessment of the affected area or participants are unable to stop using topical corticosteroids for skin (excluding scalp) categorised as low or medium potency · Hypersensitivity to any drugs or any ingredient of OPA‐15406 ointment · Participated in previous trials for OPA‐15406 and have been administered the IMP · Used any other investigational drug within 4 months prior or who are scheduled to participate in any other clinical trial during the trial period · Never been treated with medication for AD or who are satisfied with their current AD treatment or not responding at all to treatment with existing topical drugs for AD Additional design details: none |
| Participants | Total number randomised, age, sex, ethnicity: not reported Duration of eczema: at least 3 years Severity of eczema, body site, number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: not reported Intervention: OPA‐15406 (Difamilast) 1.% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: 0.% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · Success rate and change from baseline in IGA at week 4 · Success rate in EASI |
| Starting date | 2022 |
| Contact information | Jianzhong Zhang, rmzjz@126.com |
| Notes | Funding source: Otsuka Beijing Research Institute Declarations of interest: not declared Original language of publication: English Other: none |