Alopecia Areata
Conditions
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).
Interventions
DRUGNXC736
oral administration
DRUGPlacebo
oral administration
Sponsors
NEXTGEN Bioscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change(%) in SALT score from baseline at Week 12 | 12 weeks |
Countries
South Korea
Contacts
CONTACTHeesun Kim
CONTACTYangHye Park
Outcome results
None listed