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

Alopecia Areata Clinical Trial

— FAST-AA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865041
• Other study ID #: ASLAN003-004
• Status: Recruiting
• Phase: Phase 2
• Start date: April 14, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2023
• Source: ASLAN Pharmaceuticals
• Contact: ASLAN Pharmaceuticals
• Phone: +65 6817 9598
• Email: contact[@]aslanpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: September 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Farudodstat
Farudodstat tablets administered orally
• Placebo
Placebo tablets administered orally

Locations

Country	Name	City	State
United States	1 Site	Birmingham	Alabama
United States	1 Site	Brighton	Massachusetts
United States	1 Site	Cleveland	Ohio
United States	1 Site	Columbus	Ohio
United States	1 Site	Coral Gables	Florida
United States	1 Site	Fountain Valley	California
United States	1 Site	Indianapolis	Indiana
United States	1 Site	Louisville	Kentucky
United States	1 Site	Minneapolis	Minnesota
United States	1 Site	Nashville	Tennessee
United States	1 Site	New Brighton	Minnesota
United States	1 Site	New Haven	Connecticut
United States	1 Site	Omaha	Nebraska
United States	1 Site	Pflugerville	Texas
United States	1 Site	Saint Joseph	Missouri
United States	2 Sites	San Antonio	Texas
United States	1 Site	Santa Ana	California
United States	1 Site	Washington	District of Columbia
United States	1 Site	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ASLAN Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of adverse events (AEs) up to Week 28		Treatment Start to Week 28
Primary	Number of participants with clinically significant laboratory parameters		Treatment Start to Week 28
Primary	Number of participants with clinically significant Electrocardiogram (ECG) parameters		Treatment Start to Week 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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