Clinical trial NCT05496426: A Study of KL130008 in Adults With Severe Alopecia Areata
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety and Efficacy of KL130008 Capsule in Patients With Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Hypotrichosis
Hair Diseases
Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]
timeFrame: Week 36
measure: Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]
timeFrame: Week 24, 36
measure: Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]
timeFrame: Week 24, 36
measure: Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]
timeFrame: Week 24, 36
measure: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]
timeFrame: Week 24, 36
measure: Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline [ Time Frame: Week 24, 36 ]
timeFrame: Week 24, 36
measure: Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline
timeFrame: Week 24, 36
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangzhou
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xingqi Zhang
role: PRINCIPAL_INVESTIGATOR
References: