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NCT06104839 Clinical Trial

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

Alopecia Areata Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients With Severe Alopecia Areata

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06104839
Other study ID # NXC736-101
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2024
Est. completion date June 30, 2025

Study information
Verified date October 2023
Source NEXTGEN Bioscience
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 96
Est. completion date June 30, 2025
Est. primary completion date June 24, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - Men or women between =19 and =65 years of age at the time of informed consent - Severe alopecia areata as assessed by a SALT score of =50 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NXC736
oral administration
• Placebo
oral administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NEXTGEN Bioscience

Outcome
Type Measure Description Time frame Safety issue
Primary Change(%) in SALT score from baseline at Week 12 12 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05051761 - Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata Phase 3
Active, not recruiting NCT03570749 - A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Phase 2/Phase 3
Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Terminated NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A