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

NCT05368103 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HZNP-DAX-201
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 13

Brief 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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in SALT Score at Week 24

  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 baseline indicated a reduction in AA symptoms. Baseline indicates last non-missing valid observation prior to the first dose of daxdilimab.

  Baseline to Week 24

Secondary Outcomes (17)

• Percent Change From Baseline in SALT Score at Weeks 12, 16, 20, 28, 32, and 36

  Baseline to Weeks 12, 16, 20, 28, 32, and 36

• Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 12, 16, 20, 24, 28, 32, and 36

  Baseline to Weeks 12, 16, 20, 24, 28, 32, and 36

• Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 12, 16, 20, 24, 28, 32, and 36

  Weeks 12, 16, 20, 24, 28, 32, and 36

• Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 12, 16, 20, 24, 28, 32, and 36

  Weeks 12, 16, 20, 24, 28, 32, and 36

• Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 12, 16, 20, 24, 28, 32, and 36

  Weeks 12, 16, 20, 24, 28, 32, and 36

Study Arms (1)

Daxdilimab

EXPERIMENTAL

Nine sets of Daxdilimab injections over a total of 32 weeks.

Biological: Daxdilimab

Interventions

Daxdilimab BIOLOGICAL

Daxdilimab will be administered subcutaneously as two injections for each dose.

Also known as: HZN-7734

Daxdilimab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (13)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

First OC Dermatology Research, Inc.

Fountain Valley, California, 92708, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Progressive Clinical Research, P.A.

San Antonio, Texas, 78213, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Dr Dusan Sajic Medicine Professional Corporation

Guelph, Ontario, N1L 0B7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2,, Canada

Location

Innovaderm Research

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche Saint-Louis (Quebec)

Québec, G1W 4R4, Canada

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 10, 2022
• Study Start: April 27, 2022
• Primary Completion: August 7, 2023
• Study Completion: January 26, 2024
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); US (6)