RecruitingPhase 2NCT06104839
Safety and Efficacy of Oral NXC-736 in Adult Participants With Moderate and Severe Alopecia Areata
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients With Moderate and Severe Alopecia Areata
Sponsor
NEXTGEN Bioscience
Enrollment
73 participants
Start Date
Sep 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).
Eligibility
Min Age: 19 YearsMax Age: 65 Years
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
DRUGNXC736
oral administration
DRUGPlacebo
oral administration
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06104839
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