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

• Sponsor: NEXTGEN Bioscience (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06104839
• Collaborator: (none)
• Enrollment: 96
• Arms: 2
• Anticipated Duration (Months): 14.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: NXC736; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Apr 1, 2024
• Anticipated Primary Completion Date: Jun 24, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NXC736	Drug: NXC736; oral administration
Placebo Comparator: Placebo	Drug: Placebo; oral administration

Outcome Measures

Primary Outcome Measures

1. Change(%) in SALT score from baseline at Week 12 [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NEXTGEN Bioscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NEXTGEN Bioscience
• ClinicalTrials.gov Identifier: NCT06104839
• Other Study ID Numbers: NXC736-101
• First Posted: Oct 27, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alopecia; Alopecia Areata

Study Results

No Results Posted as of Oct 27, 2023