Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata (NCT05368103) | Clinical Trial Compass
CompletedPhase 2
Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata
United States30 participantsStarted 2022-04-27
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Willing and able to give informed consent.
✓. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
✓. Adult men or women 18 to 65 years of age.
✓. Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the trial.
✓. Clinical diagnosis of moderate-to-severe AA - defined as meeting the following criteria:
Exclusion criteria
✕. Individuals involved in the conduct of the trial, their employees, or immediate family members of such individuals.
✕. Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with the evaluation of the IP or interpretation of trial results.
✕. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobulin (Ig) therapy.
✕. Participant has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products and protective apparel are recommended when sun exposure cannot be avoided.
✕. Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection, splenectomy, or any underlying condition that in the opinion of the investigator significantly predisposes the participant to infection.
What they're measuring
1
Percent Change From Baseline in SALT Score at Week 24
✕. Confirmed positive test for hepatitis B serology defined as:
✕. Positive test for hepatitis C virus antibody.
✕. Active tuberculosis (TB), or a positive TB test at Screening. Participant will be evaluated for latent TB infection with a purified protein derivative (PPD) test or a QuantiFERON-TB Gold test. Participants who demonstrate evidence of latent TB infection (either PPD ≥5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille Calmette-Guérin vaccination status will not be allowed to participate in the trial, unless documented history of appropriate treatment for active or latent TB. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.