The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Drug: KL130008 Drug: Placebo
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangzhou, China
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
Percentage of Participants Achieving SALT ≤ 20
Time frame: Week 24
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]
Percentage of Participants Achieving SALT ≤ 20
Time frame: Week 36
Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]
Percent change from baseline in SALT score
Time frame: 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
Time frame: 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
Time frame: Week 24, 36
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]
Percentage of Participants Achieving SALT ≤ 10
Time frame: 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
Time frame: Week 24, 36
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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
Time frame: Week 24, 36