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The main purpose of this study is to measure the efficacy of farudodstat compared to placebo at Week 12 from the treatment start, in adult participants with Alopecia Areata (AA) with 30% or greater scalp hair loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Farudodstat for 12 weeks followed by placebo for 12 weeks | Experimental | Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks |
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| Placebo for 12 weeks followed by farudodstat for 12 weeks | Experimental | Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Farudodstat | Drug | Farudodstat tablets administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. | The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | Treatment Start to Week 12 |
| Incidence of adverse events (AEs) up to Week 28 | Treatment Start to Week 28 | |
| Number of participants with clinically significant laboratory parameters | Treatment Start to Week 28 | |
| Number of participants with clinically significant Electrocardiogram (ECG) parameters | Treatment Start to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. | The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | Treatment Start to Week 12 |
| Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start. |
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Inclusion Criteria:
Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent)
Moderate, severe, or very severe Alopecia Areata (AA), as determined by meeting the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ASLAN Pharmaceuticals | Contact | +65 6817 9598 | contact@aslanpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | ASLAN Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 Site | Recruiting | Birmingham | Alabama | 35205 | United States |
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Approximately 60 participants will be randomized in into one of two treatment sequences:
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| Placebo | Drug | Placebo tablets administered orally |
|
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The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). |
| Treatment Start to Week 12 |
| Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start. | The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | Treatment Start to Week 12 |
| Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start. | The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | Treatment Start to Week 12 |
| Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start. | The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | Treatment Start to Week 12 |
| Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start. | The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | Treatment Start to Week 12 |
| Proportion of participants with Scalp Hair Assessment Patient Reported Outcome (PRO)™ score of 0 or 1 with a ≥2-point improvement at Week 12 from the treatment start among participants with a score of ≥3 at baseline. | Participants will assess the severity of their scalp hair loss using 5-point Scalp Hair Assessment PRO™️ scale (0-4) with 4 being the most scalp hair loss | Treatment Start to Week 12 |
| Proportion of participants achieving Clinician Reported Outcome (ClinRO) measure for Eyebrow Hair Loss™ 0 or 1 with ≥2-point improvement from baseline (Among Participants with scores ≥2 at Baseline) at Week 12 from the treatment start. | ClinRO is scored from 0 to 3 with the 3 representing the most eyebrow hair loss. | Treatment Start to Week 12 |
| Proportion of participants achieving Clinician Reported Outcome (ClinRO) measure for Eyelash Hair Loss™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at baseline) at Week 12 from the treatment start. | ClinRO is scored from 0 to 3 with the 3 representing the most eyelash hair loss. | Treatment Start to Week 12 |
| Proportion of participants achieving Patient Reported Outcome (PRO) Measure for Eyebrows™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at baseline) at Week 12 from the treatment start. | Patient's self-assessment of the overall severity of eyebrow hair loss is measured by a 4-point scale (0-3) with photoguide with 3 being the most eyebrow hair loss. | Treatment Start to Week 12 |
| Proportion of participants achieving Patient Reported Outcome (PRO) Measure for Eyelashes™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at Baseline) at Week 12 from the treatment start. | Patient's self-assessment of the overall severity of eyelash hair loss is measured by a 4-point scale (0-3) with photoguide with 3 being the most eyelash hair loss. | Treatment Start to Week 12 |
| Proportion of participants achieving any amount of hair regrowth at Week 12 after treatment start among participants with alopecia totalis/alopecia universalis (AT/AU) | Treatment Start to Week 12 |
| 1 Site | Recruiting | Fountain Valley | California | 92708 | United States |
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| 1 Site | Recruiting | Santa Ana | California | 92701 | United States |
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| 1 Site | Recruiting | New Haven | Connecticut | 06519 | United States |
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| 1 Site | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
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| 1 Site | Recruiting | Coral Gables | Florida | 33134 | United States |
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| 1 Site | Recruiting | Indianapolis | Indiana | 46250 | United States |
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| 1 Site | Recruiting | Louisville | Kentucky | 40241 | United States |
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| 1 Site | Recruiting | Brighton | Massachusetts | 02135 | United States |
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| 1 Site | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| 1 Site | Recruiting | New Brighton | Minnesota | 55112 | United States |
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| 1 Site | Recruiting | Saint Joseph | Missouri | 64506 | United States |
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| 1 Site | Recruiting | Omaha | Nebraska | 68114 | United States |
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| 1 Site | Recruiting | Cleveland | Ohio | 44195 | United States |
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| 1 Site | Recruiting | Columbus | Ohio | 43215 | United States |
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| 1 Site | Recruiting | Nashville | Tennessee | 37215 | United States |
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| 1 Site | Recruiting | Pflugerville | Texas | 78660 | United States |
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| 2 Sites | Recruiting | San Antonio | Texas | 78218 | United States |
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| 1 Site | Recruiting | Webster | Texas | 77598 | United States |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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