Safety and Efficacy of Oral NXC-736 in Adult Participants with Moderate and Severe Alopecia Areata

Nextgen Bioscience

Status and phase: Enrolling; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: NXC736

Study type: Interventional

Funder types: Industry

Identifiers

NCT06104839

NXC736-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).

Enrollment: 96 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

NXC736

Experimental group

Treatment:

Drug: NXC736

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo