Phase 3 Alopecia Areata Trial, Recruiting NCT05723198 Sponsor: Eli Lilly and Company Condition: Alopecia Areata
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Phase 3 Alopecia Areata Trial, Recruiting

NCT05723198
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 12 and 17 years old (note: younger children aged 6–11 may join after the older age group has been enrolled)
  • You have been diagnosed with severe alopecia areata (significant patchy hair loss) for at least 1 year
  • Your current episode of hair loss has been ongoing for at least 6 months
  • At least 50% of your scalp hair is lost, as measured by a standard scoring tool called the SALT score
  • You have already tried at least one available treatment for your hair loss (such as a cream or other therapy) and it did not work well enough
  • You have previously received psychological counseling related to your hair loss
  • Your current severe hair loss episode has lasted less than 8 years (if it has lasted 8 years or more, you may still qualify if some hair regrowth — on its own or with treatment — has been seen in the affected areas during that time — confirm with trial site)

Who may not be able to join:

  • Your hair loss is mainly of the "diffuse" type, meaning general shedding all over rather than distinct patches
  • You have another type of hair loss condition at the same time, such as hair pulling disorder, stress-related shedding, chemotherapy-related hair loss, or a scalp condition like a fungal infection or psoriasis
  • You are largely or completely unable to care for yourself, for example if you are confined to bed
  • You have high blood pressure that is not well controlled by treatment
  • You have had a major operation within the past 8 weeks, or you are expected to need one during the study
  • You have a serious or unstable health condition affecting your heart, lungs, liver, digestive system, hormones, blood, brain, or mental health that the study doctor feels could put you at risk or affect the study results (confirm with trial site)
  • You have tested positive for the Hepatitis B virus
  • You have an active Hepatitis C infection confirmed by specific blood tests
  • You have HIV or have tested positive for HIV antibodies

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

Australian sites

Skin and Cancer Foundation Australia - Darlinghurst Clinic, Darlinghurst,
Sinclair Dermatology, Melbourne,
3 9013 0099
Institute for Skin, Health, and Immunity, Mitcham,
412476267
Veracity Clinical Research Pty Ltd, Wooloongabba,
730391346

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
27 February 2023
Est. completion
1 March 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇯🇵 Japan 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov