Alopecia AreataPhase 2FAST-AANCT05865041
Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants
A Phase 2 study testing Farudodstat in people with Alopecia Areata, run by ASLAN Pharmaceuticals at 19 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Farudodstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 19 sitesUnited States
- Study dates
- 14 Apr 2023to 31 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
1 Site
Birmingham, Alabama, 35205
fastaa@aslanpharma.com
- Recruiting
1 Site
Brighton, Massachusetts, 02135
fastaa@aslanpharma.com
- Recruiting
1 Site
Cleveland, Ohio, 44195
fastaa@aslanpharma.com
- Recruiting
1 Site
Columbus, Ohio, 43215
fastaa@aslanpharma.com
- Recruiting
1 Site
Coral Gables, Florida, 33134
fastaa@aslanpharma.com
- Recruiting
1 Site
Fountain Valley, California, 92708
fastaa@aslanpharma.com
- Recruiting
1 Site
Indianapolis, Indiana, 46250
fastaa@aslanpharma.com
- Recruiting
1 Site
Louisville, Kentucky, 40241
fastaa@aslanpharma.com
- Recruiting
1 Site
Minneapolis, Minnesota, 55455
fastaa@aslanpharma.com
- Recruiting
1 Site
Nashville, Tennessee, 37215
fastaa@aslanpharma.com
- Recruiting
1 Site
New Brighton, Minnesota, 55112
fastaa@aslanpharma.com
- Recruiting
1 Site
New Haven, Connecticut, 06519
fastaa@aslanpharma.com
- Recruiting
1 Site
Omaha, Nebraska, 68114
fastaa@aslanpharma.com
- Recruiting
1 Site
Pflugerville, Texas, 78660
fastaa@aslanpharma.com
- Recruiting
1 Site
Saint Joseph, Missouri, 64506
fastaa@aslanpharma.com
- Recruiting
2 Sites
San Antonio, Texas, 78218
fastaa@aslanpharma.com
- Recruiting
1 Site
Santa Ana, California, 92701
fastaa@aslanpharma.com
- Recruiting
1 Site
Washington D.C., District of Columbia, 20037
fastaa@aslanpharma.com
- Recruiting
1 Site
Webster, Texas, 77598
fastaa@aslanpharma.com
About this study
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
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.
- Conditions
- Alopecia Areata
- Being tested
- Farudodstat, Placebo
- Keywords
- farudodstat, alopecia areata, DHODH inhibitor, ASLAN003
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FarudodstatDrug
Also called ASLAN003
Farudodstat tablets administered orally
PlaceboDrug
Also called Placebo Comparator
Placebo tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Farudodstat; Drug: 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 Receives: Drug: Farudodstat; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Treatment Start to Week 12
Incidence of adverse events (AEs) up to Week 28
Measured: Treatment Start to Week 28
Number of participants with clinically significant laboratory parameters
Measured: Treatment Start to Week 28
Number of participants with clinically significant Electrocardiogram (ECG) parameters
Measured: 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.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Treatment Start to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start14 Apr 2023
- Primary completion12 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASLAN Pharmaceuticals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, ASLAN Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865041
- Sponsor's protocol ID
- ASLAN003-004
- Acronym
- FAST-AA
- Status last verified
- Dec 2023
- First submitted
- 15 Apr 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05865041
- Acronym / sponsor ID
- FAST-AA / ASLAN003-004
- Conditions
- Alopecia Areata
- Keywords
- farudodstat, alopecia areata, DHODH inhibitor, ASLAN003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ASLAN PharmaceuticalsUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 12 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Farudodstat for 12 weeks followed by placebo for 12 weeks | Experimental | Drug: Farudodstat, Drug: PlaceboFarudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks |
| Placebo for 12 weeks followed by farudodstat for 12 weeks | Experimental | Drug: Farudodstat, Drug: PlaceboMatching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FarudodstatAlso: ASLAN003Farudodstat tablets administered orally | Drug | Farudodstat for 12 weeks followed by placebo for 12 weeks, Placebo for 12 weeks followed by farudodstat for 12 weeks |
| PlaceboAlso: Placebo ComparatorPlacebo tablets administered orally | Drug | Farudodstat for 12 weeks followed by placebo for 12 weeks, Placebo for 12 weeks followed by farudodstat for 12 weeks |
Primary outcome
Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
Time frame: 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
Time frame: Treatment Start to Week 28
Number of participants with clinically significant laboratory parameters
Time frame: Treatment Start to Week 28
Number of participants with clinically significant Electrocardiogram (ECG) parameters
Time frame: Treatment Start to Week 28
12 secondary outcomes
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
Time frame: Treatment Start to Week 12
Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.
Time frame: 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.
Time frame: Treatment Start to Week 12
Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.
Time frame: 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.
Time frame: Treatment Start to Week 12
Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Treatment Start to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
ASLAN Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Farudodstat in people with Alopecia Areata, run by ASLAN Pharmaceuticals at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASLAN Pharmaceuticals (+65 6817 9598, contact@aslanpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. (time frame: Treatment Start to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.