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

NCT ID: NCT06104839

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NXC736

Group Type EXPERIMENTAL

NXC736

Intervention Type DRUG

oral administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral administration

Interventions

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NXC736

oral administration

Intervention Type DRUG

Placebo

oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NEXTGEN Bioscience

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital.

Seoul, , South Korea

Site Status RECRUITING

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Heesun Kim

Role: CONTACT

Phone: 82-31-606-3220

Email: [email protected]

YangHye Park

Role: CONTACT

Email: [email protected]

Facility Contacts

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Osang Kwon

Role: primary

Bark-Lynn Lew

Role: primary

Other Identifiers

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NXC736-101

Identifier Type: -

Identifier Source: org_study_id