Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20221881 | Registry Identifier | KL223-II-05 |
Not provided
Not provided
Not provided
This adjustment to the company's development strategy is unrelated to safety or efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KL130008 capsule High Dose | Experimental | KL130008 capsule administered orally |
|
| KL130008 capsule Middle Dose | Experimental | KL130008 capsule administered orally |
|
| KL130008 capsule Low Dose | Experimental | KL130008 capsule administered orally |
|
| Placebo | Placebo Comparator | Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL130008/Placebo | Drug | Drug: KL130008 Drug: Placebo |
|
| 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 |
| 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 ] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xingqi Zhang | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangzhou | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |