A Study of KL130008 in Adults With Severe Alopecia Areata

NCT05496426 | Terminated Phase 2

• 2 other identifiers: KL223-II-05CTR20221881
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Hypotrichosis; Hair Diseases

Outcome Measures

Primary Outcomes (1)

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

  Percentage of Participants Achieving SALT ≤ 20

  Week 24

Secondary Outcomes (7)

• Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]

  Week 36

• Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]

  Week 24, 36

• Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]

  Week 24, 36

• Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]

  Week 24, 36

• Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]

  Week 24, 36

Study Arms (4)

KL130008 capsule High Dose

EXPERIMENTAL

KL130008 capsule administered orally

Drug: KL130008/Placebo

KL130008 capsule Middle Dose

EXPERIMENTAL

KL130008 capsule administered orally

Drug: KL130008/Placebo

KL130008 capsule Low Dose

EXPERIMENTAL

KL130008 capsule administered orally

Drug: KL130008/Placebo

Placebo

PLACEBO COMPARATOR

Placebo administered orally

Drug: KL130008/Placebo

Interventions

KL130008/Placebo DRUG

Drug: KL130008 Drug: Placebo

KL130008 capsule High Dose; KL130008 capsule Low Dose; KL130008 capsule Middle Dose; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent.
• Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form.
• Diagnosed alopecia areata(AA) without other reasons caused alopecia.
• 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.
• 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.

You may not qualify if:

• Known history of anaphylaxis to any of the ingredients and/or other similar products.
• 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.
• Previously treated with JAK inhibitors.
• Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization.
• Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization.
• With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease.
• 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.
• 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.
• Subjects who are unsuitable to the trial, as identified by the investigator.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangzhou, 510080, China

Location

MeSH Terms

Conditions

Alopecia Areata; Hypotrichosis; Hair Diseases

Condition Hierarchy (Ancestors)

Alopecia; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xingqi Zhang

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: November 9, 2022
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)