Evaluating NXC-736 for treating moderate to 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
This study is testing if an oral medication called NXC-736 can help adults with moderate to severe alopecia areata regrow their hair and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | NEXTGEN Bioscience Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06104839 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of NXC-736, an oral medication, in adults suffering from moderate to severe alopecia areata. Participants will receive either NXC-736 or a placebo, and their hair loss will be monitored using the SALT scoring system. The study will include individuals aged 19 to 65 who have experienced hair loss for at least six months but less than eight years. The goal is to determine if NXC-736 can promote hair regrowth and improve the quality of life for those affected by this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 with moderate to severe alopecia areata lasting between six months and eight years.
Not a fit: Patients with other types of alopecia or active scalp conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients struggling with hair loss due to alopecia areata.
How similar studies have performed: While there have been studies on alopecia treatments, the specific approach of using NXC-736 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital. — Seoul, South Korea (Recruiting)
- Kyung Hee University Hospital at Gangdong — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Heesun Kim
- Email: flower@nextgenbio.co.kr
- Phone: 82-31-606-3220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.