Phase 2a Clinical Study to evaluate efficacy and safety of JTE-451 ointment in patients with plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Registration Number
- JPRN-jRCT2031210232
- Lead Sponsor
- Miwa Yasushi
- Brief Summary
There were no stastistical significant difference in the primary endpoint between the active group and the placebo group. JTE-451 ointment was generally safe and tolerated in patients with plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 67
1. Japanese subjects who have clinical diagnosis of chronic plaque psoriasis for at least 6 months and whose disease condition is stable, at informed consent
2. Subjects with a PASI score >=5.0
3. Subjects with a PGA score of 2, 3 or 4
4. Subjects with BSA affected >=3% and <=20% (except for the hairy scalp)
1. Subjects with psoriasis other than plaque psoriasis
2. Subjects who have shown no efficacy by treatment with specific biologics
3. Subjects with dermatologic or inflammatory condition that would affect the study assessments determined by the investigator
4. Subjects with acute active bacterial, fungal or viral skin infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with >=75% improvement in PASI score from Baseline
- Secondary Outcome Measures
Name Time Method