Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Parallel Group Treatment, Phase 2a, Double-blind, Two-arm Study to Investigate the Efficacy and Safety of Farudodstat Tablets Compared With Its Placebo in Male or Female Alopecia Areata Participants Aged 18 Years and Older With 30% or Greater Scalp Hair Loss

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Farudodstat
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.) At least 30% scalp hair loss, as defined by a SALT score ≥30 Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have AA for longer than 7 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 7 years No appreciable change (i.e., change exceeding 20 points on SALT score) in terminal hair regrowth within 6 months Exclusion Criteria: Known history of androgenic alopecia or female pattern hair loss prior to AA Other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA) History or presence of hair transplants Other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Approximately 60 participants will be randomized in into one of two treatment sequences: Sequence one: Farudodstat 100mg twice daily for 12 weeks followed by placebo twice daily for 12 weeks Sequence two: Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Farudodstat for 12 weeks followed by placebo for 12 weeks<br>Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks | Drug: Farudodstat<br>* Farudodstat tablets administered orally<br>* Other names: ASLAN003;Drug: Placebo<br>* Placebo tablets administered orally<br>* Other names: Placebo Comparator;|
| Experimental: Placebo for 12 weeks followed by farudodstat for 12 weeks<br>Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks | Drug: Farudodstat<br>* Farudodstat tablets administered orally<br>* Other names: ASLAN003;Drug: Placebo<br>* Placebo tablets administered orally<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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farudodstat, alopecia areata, DHODH inhibitor, ASLAN003