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
1 other identifier
interventional
73
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
April 13, 2026
April 1, 2026
2.2 years
October 23, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change(%) in SALT score from baseline at Week 12
12 weeks
Study Arms (2)
NXC736
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Hospital.
Seoul, 03080, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2023
First Posted
October 27, 2023
Study Start
September 1, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04