Recruiting NCT06104839
Safety and Efficacy of Oral NXC-736 in Adult Participants With Moderate and Severe Alopecia Areata
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NXC736, Placebo.
- Who it may be relevant to
- Registry conditions: Alopecia Areata. Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).
Interventions
- Drug NXC736
oral administration - Drug Placebo
oral administration
Primary outcome measures
- Change(%) in SALT score from baseline at Week 12 [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 2 centers
- Seoul National University Hospital. — Seoul
- Kyung Hee University Hospital at Gangdong — Seoul
Identifiers
NCT: NCT06104839 · NXC736-101