Alopecia Areata
Conditions
Keywords
farudodstat, alopecia areata, DHODH inhibitor, ASLAN003
Brief summary
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.
Interventions
DRUGFarudodstat
Farudodstat tablets administered orally
DRUGPlacebo
Placebo tablets administered orally
Sponsors
ASLAN Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.) 2. At least 30% scalp hair loss, as defined by a SALT score ≥30 3. 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 4. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
| Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
| 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. | Treatment Start to Week 12 | 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 |
| 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. | Treatment Start to Week 12 | ClinRO is scored from 0 to 3 with the 3 representing the most eyebrow hair loss. |
| Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
| 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. | Treatment Start to Week 12 | 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. |
| 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. | Treatment Start to Week 12 | 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. |
| 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 | — |
| 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. | Treatment Start to Week 12 | ClinRO is scored from 0 to 3 with the 3 representing the most eyelash hair loss. |
| Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
| Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
| Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start. | Treatment Start to Week 12 | 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). |
Countries
United States
Contacts
Primary ContactASLAN Pharmaceuticals
Outcome results
None listed