Safety and Efficacy of Oral NXC-736 in Adult Participants with Moderate and Severe Alopecia Areata
- Registration Number
- NCT06104839
- Lead Sponsor
- NEXTGEN Bioscience
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
- Men or women between ≥19 and ≤65 years of age at the time of informed consent
- Moderate and severe alopecia areata as assessed by a SALT score of 25% ≤ SALT < 95% at Screening and Day 1/Baseline
- Current episode of hair loss for ≥6 months but <8 years
- Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
- Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
Exclusion Criteria
-
Participants with the following medical history confirmed during screening:
- ohter Types of alopecia other than alopecia areata (such as cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, androgenic alopecia, telogen effluvium, etc.)
-
Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
-
Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NXC736 NXC736 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change(%) in SALT score from baseline at Week 12 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Seoul National University Hospital.
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of