Phase 2 Alopecia Areata Trial, Terminated NCT05556265 Sponsor: Bristol-Myers Squibb Condition: Alopecia Areata
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT05556265) looked at a medicine called deucravacitinib in people with alopecia areata — a condition where the immune system attacks hair follicles, causing hair loss. A total of 94 participants took part in the first 24-week phase: 32 received deucravacitinib once a day (called QD), 31 received it twice a day (called BID), and 31 received a placebo (an inactive treatment). The trial's main measurement for hair loss used a tool called the SALT score, which runs from 0 to 100 — where a lower number means less hair loss on the scalp. The trial also tracked the number of participants who experienced medical events (called adverse events) during the study, as well as blood test results and heart trace (ECG) readings. The reported data shows that, after 24 weeks, the average SALT score change from the starting point was −5.8 points in the once-daily deucravacitinib group, +1.0 points in the twice-daily group, and −7.3 points in the placebo group. (A negative number means the score went down, i.e. less hair loss on the scale, compared to where each group started.) Regarding medical events during the first 24 weeks, the reported data shows that 25 out of 32 participants in the once-daily group, 28 out of 31 in the twice-daily group, and 20 out of 31 in the placebo group experienced at least one adverse event. Serious adverse events were reported in 1 participant in each of the two deucravacitinib groups and none in the placebo group. The reported data shows no participants in any group reached the most severe grades (Grade 3 or 4) for abnormal blood test results across either study period. A small number of notable heart trace readings were recorded — 2 participants in the twice-daily group and 1 in the placebo group during the first period — but further detail on what these represented was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Alopecia Areata Trial, Terminated

NCT05556265
Terminated Phase 2 🇦🇺 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 have been officially diagnosed with alopecia areata (a condition causing patchy hair loss) for at least 6 months.
  • Your current episode of hair loss on the scalp has been ongoing for at least 6 months.
  • Your current episode of hair loss covering 50% or more of your scalp has lasted no longer than 8 years.
  • Your hair loss has been stable, meaning there has been no significant natural regrowth (more than 10%) in the last 6 months.
  • At least 50% of your scalp hair is currently lost, as measured by a standard scoring tool called the SALT score — people with complete scalp hair loss, with or without body hair loss, may also be included.

Who may not be able to join:

  • You have a different type of alopecia areata called "diffuse-type," or another kind of hair loss condition (such as traction alopecia or scarring hair loss conditions) rather than the standard patchy form.
  • You have another active skin condition affecting your scalp that could make it difficult for the study team to accurately measure your hair loss.
  • You have extensive tattoos on your scalp that could make it difficult for the study team to accurately measure your hair loss.
  • There are additional criteria not listed here that may also affect whether you can join (confirm with trial site).

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 28 July 2026
Phase 2: approximately ~30% 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: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution - 0003, Kogarah, New South Wales
Local Institution - 0005, Carlton, Victoria

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

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
8 November 2022
Est. completion
6 January 2024

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇫🇷 France 🇯🇵 Japan 🇵🇱 Poland 🇺🇸 United States

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

Primary endpoints

Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period; Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period; Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period; Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period; Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Labora...

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: 28 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