NCT05865041

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

April 15, 2023

Last Update Submit

December 12, 2023

Conditions

Alopecia Areata

Keywords

farudodstatalopecia areataDHODH inhibitorASLAN003

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.

    Treatment Start to Week 12

  • Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.

    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.

    Treatment Start to Week 12

  • Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.

    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.

    Treatment Start to Week 12

  • +7 more secondary outcomes

Study Arms (2)

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

Drug: FarudodstatDrug: Placebo

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

Drug: FarudodstatDrug: Placebo

Interventions

FarudodstatDRUG

Farudodstat tablets administered orally

Also known as: ASLAN003
Farudodstat for 12 weeks followed by placebo for 12 weeksPlacebo for 12 weeks followed by farudodstat for 12 weeks
PlaceboDRUG

Placebo tablets administered orally

Also known as: Placebo Comparator
Farudodstat for 12 weeks followed by placebo for 12 weeksPlacebo for 12 weeks followed by farudodstat for 12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

1 Site

Birmingham, Alabama, 35205, United States

RECRUITING

1 Site

Fountain Valley, California, 92708, United States

RECRUITING

1 Site

Santa Ana, California, 92701, United States

RECRUITING

1 Site

New Haven, Connecticut, 06519, United States

RECRUITING

1 Site

Washington D.C., District of Columbia, 20037, United States

RECRUITING

1 Site

Coral Gables, Florida, 33134, United States

RECRUITING

1 Site

Indianapolis, Indiana, 46250, United States

RECRUITING

1 Site

Louisville, Kentucky, 40241, United States

RECRUITING

1 Site

Brighton, Massachusetts, 02135, United States

RECRUITING

1 Site

Minneapolis, Minnesota, 55455, United States

RECRUITING

1 Site

New Brighton, Minnesota, 55112, United States

RECRUITING

1 Site

Saint Joseph, Missouri, 64506, United States

RECRUITING

1 Site

Omaha, Nebraska, 68114, United States

RECRUITING

1 Site

Cleveland, Ohio, 44195, United States

RECRUITING

1 Site

Columbus, Ohio, 43215, United States

RECRUITING

1 Site

Nashville, Tennessee, 37215, United States

RECRUITING

1 Site

Pflugerville, Texas, 78660, United States

RECRUITING

2 Sites

San Antonio, Texas, 78218, United States

RECRUITING

1 Site

Webster, Texas, 77598, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chief Medical Officer

    ASLAN Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

ASLAN Pharmaceuticals

CONTACT

+65 6817 9598contact@aslanpharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2023

First Posted

May 18, 2023

Study Start

April 14, 2023

Primary Completion

September 12, 2024

Study Completion

October 31, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(19)