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

Last updated: December 12, 2024
Sponsor: NEXTGEN Bioscience
Overall Status: Active - Recruiting

Phase

2

Condition

Alopecia

Hair Loss

Treatment

Placebo

NXC736

Clinical Study ID

NCT06104839
NXC736-101
  • Ages 19-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 asassessed by the Investigator

  • Willing to keep the same hair style and color (eg, hair products, process, andtiming for hair appointments) for the duration of the study

Exclusion

Exclusion Criteria:

  • Participants with the following medical history confirmed during screening:

  • ohter Types of alopecia other than alopecia areata (such ascicatricial/scarring alopecia [including central centrifugal cicatricialalopecia], traction alopecia, androgenic alopecia, telogen effluvium, etc.)

  • Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalpcondition that may interfere with the SALT assessment

  • Previous use of Janus kinase (JAK) inhibitor (oral or topical), includingparticipation in clinical studies of JAK inhibitors

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 01, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital.

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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