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NCT05368103 · ClinicalTrials.gov registry record · Phase 2

Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT05368103: Completed Phase 2 study, sponsored by Amgen.

NCT05368103 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05368103, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to assess the preliminary efficacy, safety, tolerability, PK, and PD of Daxdilimab in participants with moderate to severe AA, with ≥50% and ≤95% total scalp hair loss as defined by the SALT score at Screening and Day 1.

Primary Outcome

The SALT score determined the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for AA. The Investigator determined the percent scalp hair loss in a given quadrant, multiplied this by the total scalp area delineated by that quadrant, and summed the resultant numbers for each quadrant to give the total percent scalp hair loss with a range of 0-100. Higher scores indicated more severe AA symptoms. A decrease in SALT score from b

Interventions

  • BIOLOGICAL Daxdilimab

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-04-27
Est. Completion 2024-01-26
Phase Phase 2
Amgen

558 total trials

What the finished NCT05368103 record still lists

NCT05368103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Daxdilimab is the first listed.

NCT05368103 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05368103 about?

NCT05368103 is a clinical study titled "Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata". The purpose of this study is to assess the preliminary efficacy, safety, tolerability, PK, and PD of Daxdilimab in participants with moderate to severe AA, with ≥50% and ≤95% total scalp hair loss as defined by the SALT score at Screening and Day 1.

What is the current status of trial NCT05368103?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-04-27. Estimated completion is 2024-01-26.

What interventions are being tested in trial NCT05368103?

The interventions under investigation include: Daxdilimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05368103?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05368103's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05368103, the US trial registry maintained by the National Library of Medicine. NCT05368103 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.