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Efficacy and safety of farudodstat for treating alopecia areata

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

Phase 2 Interventional ASLAN Pharmaceuticals · NCT05865041

This study is testing a new medication called farudodstat to see if it can help adults with alopecia areata who have lost a lot of hair.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorASLAN Pharmaceuticals Academic / other
Locations19 sites (Birmingham, Alabama and 18 other locations)
Trial IDNCT05865041 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of farudodstat, a DHODH inhibitor, compared to a placebo in adult participants suffering from alopecia areata with significant hair loss. The study aims to measure the treatment's effectiveness at Week 12, focusing on individuals with at least 30% scalp hair loss. Participants must meet specific criteria regarding the severity and duration of their condition to be eligible for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe alopecia areata and at least 30% scalp hair loss.

Not a fit: Patients with other types of hair loss, such as androgenic alopecia or those who do not meet the severity criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with alopecia areata, potentially improving hair regrowth and quality of life.

How similar studies have performed: While this approach is novel in the context of alopecia areata, similar studies targeting hair loss conditions have shown varying degrees of success.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Birmingham, Alabama and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alopecia Areatafarudodstatalopecia areataDHODH inhibitorASLAN003
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.