A Study of KL130008 in Adults With Severe Alopecia Areata

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety and Efficacy of KL130008 Capsule in Patients With Severe Alopecia Areata

The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata

Study Overview

• Status: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: KL130008/Placebo

Detailed Description

This is a multi-center Phase 2 study to evaluate the safety and effectiveness of an investigational drug in adults (≥18 years and ≤65 years) who have 50% or greater scalp hair loss, including alopecia totalis (AT) and alopecia universalis (AU).

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510080
      • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent.
2. Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form.
3. Diagnosed alopecia areata(AA) without other reasons caused alopecia.
4. Have severe AA, as determined by all of the following:Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, including alopecia totalis (AT) and alopecia universalis (AU);No spontaneous improvement over the past 6 months;Current episode of severe AA of less than 8 years.
5. All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from the signing of informed consent, throughout the duration of the study, and for 3 months after the last dose of investigational drugs.

Exclusion Criteria:

1. Known history of anaphylaxis to any of the ingredients and/or other similar products.
2. Participated in a clinical trial of any drug or medical device and has used an investigational product (including placebo and control group) or treatment within 1 month or 5 half-lives before randomization.
3. Previously treated with JAK inhibitors.
4. Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization.
5. Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization.
6. With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease.
7. Subjects with evidence of clinical laboratory abnormalities at screening that, in the opinion of the investigator, may affect the safety of subjects or the interpretation of study results: Hemoglobin level < 10.0 g/dL. Absolute white blood cell (WBC) count /absolute neutrophil count (NEUT)/absolute lymphocyte count(LYMPH)<LLN. Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 2 × ULN, total bilirubin(TBIL)>1.5 × ULN. QTcF> 450ms. Subjects with eGFR ≤ 60 mL/min based on Cockcroft-Gault calculation.
8. The subject had or currently has a severe infection, and had a severe infection judged by the investigator within 1 month before randomization: HBV, TP-Ab, HIV, HCV, TB positive.
9. Subjects who are unsuitable to the trial, as identified by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally	Drug: KL130008/Placebo; Drug: KL130008 Drug: Placebo
Experimental: KL130008 capsule High Dose; KL130008 capsule administered orally	Drug: KL130008/Placebo; Drug: KL130008 Drug: Placebo
Experimental: KL130008 capsule Middle Dose; KL130008 capsule administered orally	Drug: KL130008/Placebo; Drug: KL130008 Drug: Placebo
Experimental: KL130008 capsule Low Dose; KL130008 capsule administered orally	Drug: KL130008/Placebo; Drug: KL130008 Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]	Percentage of Participants Achieving SALT ≤ 20	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]	Percentage of Participants Achieving SALT ≤ 20	Week 36
Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]	Percent change from baseline in SALT score	Week 24, 36
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]	Percentage of participants achieving SALT50	Week 24, 36
Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]	Percentage of participants achieving SALT75	Week 24, 36
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]	Percentage of Participants Achieving SALT ≤ 10	Week 24, 36
Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline [ Time Frame: Week 24, 36 ]	EB hair loss 0 or 1 with ≥2-point Improvement from Baseline	Week 24, 36
Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline	EL hair loss 0 or 1 with ≥2-point Improvement from Baseline	Week 24, 36

Collaborators and Investigators

• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xingqi Zhang, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Alopecia Areata; Hypotrichosis; Hair Diseases
• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Skin and Connective Tissue Diseases; Alopecia Areata; Hypotrichosis; Hair Diseases
• Other Study ID Numbers: KL223-II-05; CTR20221881 (Registry Identifier: KL223-II-05)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No