Phase 3 study for people with Alopecia Areata

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Eli Lilly and Company
Registry number NCT05723198
Started 27 February 2023 Today 16 October 2026 Estimated completion 1 March 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Skin and Cancer Foundation Australia - Darlinghurst Clinic Darlinghurst NSW Completed
Sinclair Dermatology Melbourne VIC Recruiting
Institute for Skin, Health, and Immunity Mitcham VIC Recruiting
Veracity Clinical Research Pty Ltd Wooloongabba QLD Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 6 Years to 17 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 595

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).

* Have severe areata alopecia (AA) for at least 1 year

* Diagnosis for at least 1 year

* Current AA episode of at least 6 months' duration

* SALT score ≥50% at screening and baseline

* History of trial and failure with at least 1 available treatment (topical or other) for AA

* History of psychological counseling related to AA

* Current episode of severe AA of less than 8 years.

* Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.

Exclusion Criteria:

* Primarily "diffuse" type of AA (characterized by diffuse hair shedding).

* Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.

* Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden

* Have uncontrolled arterial hypertension

* Have had major surgery within 8 weeks prior to screening or will require major surgery during the study

* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.

* Have a positive test for hepatitis B virus (HBV) infection

* Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]).

* Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Dates on the record

Started 27 February 2023
Estimated completion 1 March 2028
Registry last updated 8 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 8 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.