Clinical trial NCT05865041: Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: farudodstat
alopecia areata
DHODH inhibitor
ASLAN003
Lead sponsor: ASLAN Pharmaceuticals
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: Incidence of adverse events (AEs) up to Week 28
timeFrame: Treatment Start to Week 28
measure: Number of participants with clinically significant laboratory parameters
timeFrame: Treatment Start to Week 28
measure: Number of participants with clinically significant Electrocardiogram (ECG) parameters
timeFrame: Treatment Start to Week 28
Secondary outcomes:
measure: Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start.
timeFrame: Treatment Start to Week 12
measure: 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.
timeFrame: Treatment Start to Week 12
measure: 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.
timeFrame: Treatment Start to Week 12
measure: 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.
timeFrame: Treatment Start to Week 12
measure: 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.
timeFrame: Treatment Start to Week 12
measure: 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.
timeFrame: Treatment Start to Week 12
measure: Proportion of participants achieving any amount of hair regrowth at Week 12 after treatment start among participants with alopecia totalis/alopecia universalis (AT/AU)
timeFrame: Treatment Start to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1 Site
state: Alabama
city: Fountain Valley
country: United States
facility: 1 Site
state: California
city: Santa Ana
country: United States
facility: 1 Site
state: California
city: New Haven
country: United States
facility: 1 Site
state: Connecticut
city: Washington
country: United States
facility: 1 Site
state: District of Columbia
city: Coral Gables
country: United States
facility: 1 Site
state: Florida
city: Indianapolis
country: United States
facility: 1 Site
state: Indiana
city: Louisville
country: United States
facility: 1 Site
state: Kentucky
city: Brighton
country: United States
facility: 1 Site
state: Massachusetts
city: Minneapolis
country: United States
facility: 1 Site
state: Minnesota
city: New Brighton
country: United States
facility: 1 Site
state: Minnesota
city: Saint Joseph
country: United States
facility: 1 Site
state: Missouri
city: Omaha
country: United States
facility: 1 Site
state: Nebraska
city: Cleveland
country: United States
facility: 1 Site
state: Ohio
city: Columbus
country: United States
facility: 1 Site
state: Ohio
city: Nashville
country: United States
facility: 1 Site
state: Tennessee
city: Pflugerville
country: United States
facility: 1 Site
state: Texas
city: San Antonio
country: United States
facility: 2 Sites
state: Texas
city: Webster
country: United States
facility: 1 Site
state: Texas
Study officials:
affiliation: ASLAN Pharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: