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

Completed · Phase 2

Conditions studied: Alopecia Areata

In brief

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.

Key facts

Study ID: NCT05368103
Run by: Amgen
People needed: 30
Starts: 2022-04-27
Expected to finish: 2024-01-26
Last updated by the study team: 2025-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Presence of ≥ 50% and ≤ 95% total scalp hair loss at screening and baseline (Day 1) defined by the SALT score.
Duration of current episode of hair loss >3 months but <7 years at screening and Day 1, along with investigators' assessment that hair regrowth is possible.
No evidence of active regrowth present at baseline and no known history of significant regrowth, as per investigator's judgement, over the last 6 months.

You may not qualify if…

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.
Confirmed positive test for hepatitis B serology defined as:
Hepatitis B surface antigen (HBsAg), or
Hepatitis B core antibody (HBcAb or anti-HBc)
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.
Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus [CMV]) at any time prior to Day 1, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes.
Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Day 1.
Any of the following within 30 days prior to signing the ICF and though Day 1:
Clinically significant active infection in the opinion of the investigator, including ongoing, and chronic infection requiring antibiotics or antiviral medication (chronic nail infections are allowed). Note: Participant with a limited recurrence of a cold sore or herpes genitalis between ICF signature and Day 1 could be eligible based on the investigator's judgement.
Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives.
A participant with a documented positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test may be rescreened at least 2 weeks after a positive test if the participant is asymptomatic and at least 3 weeks after resolution of symptomatic Coronavirus Disease 2019 (COVID-19) illness.
Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Day 1.
Any acute illness or evidence of clinically significant active infection, such as fever ≥ 38.0°C (≥ 100.5°F) on Day 1.
History of clinically significant cardiac disease including unstable angina; myocardial infarction within 6 months prior to Day 1; congestive heart failure; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically significant abnormality on ECG if, in the opinion of the investigator, it would increase the risk of trial participation.
History of cancer or lymphoproliferative disease within 5 years prior to Day 1, except as follows:
In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to Screening, or
Nonmetastatic cutaneous basal cell or squamous cell carcinoma of the skin treated with apparent success with curative therapy.
Active forms of other inflammatory skin disease(s) or evidence of other skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of the Screening and through Day 1, that in the opinion of the investigator might interfere with evaluation of AA and the assessment of the activity measures.
Presence of another form of alopecia (except for androgenic alopecia).
History of male or female pattern hair loss > Hamilton stage III or > Ludwig stage II.

Where it is running

Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
First OC Dermatology Research, Inc. — Fountain Valley, California, United States
ForCare Clinical Research — Tampa, Florida, United States
DS Research — Louisville, Kentucky, United States
Progressive Clinical Research, P.A. — San Antonio, Texas, United States
Dermatology Specialists of Spokane — Spokane, Washington, United States
Enverus Medical Research — Surrey, British Columbia, Canada
Dr Dusan Sajic Medicine Professional Corporation — Guelph, Ontario, Canada
Lynderm Research Inc. — Markham, Ontario, Canada
The Centre for Clinical Trials — Oakville, Ontario, Canada
SKiN Centre for Dermatology — Peterborough, Ontario, Canada
Innovaderm Research — Montreal, Quebec, Canada
Centre de Recherche Saint-Louis (Quebec) — Québec, Canada

Full record on ClinicalTrials.gov

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