A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata

Amgen13 sites in 2 countries30 target enrollmentApril 27, 2022

ConditionsAlopecia Areata

InterventionsDaxdilimab

DrugsDaxdilimab

Overview

Phase: Phase 2
Intervention: Daxdilimab
Conditions: Alopecia Areata
Sponsor: Amgen
Enrollment: 30
Locations: 13
Primary Endpoint: Percent Change From Baseline in SALT Score at Week 24
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

Approximately 30 participants will be enrolled to receive daxdilimab administered subcutaneously over 32 weeks. The maximum trial duration per participant is approximately 52 weeks, including up to 30 days for the screening period, 32 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 16 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study. Study acquired from Horizon in 2024.

Registry

clinicaltrials.gov

Start Date

April 27, 2022

End Date

January 26, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.

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.
•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.

Arms & Interventions

Daxdilimab

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

Intervention: Daxdilimab

Outcomes

Primary Outcomes

Percent Change From Baseline in SALT Score at Week 24

Time Frame: Baseline to 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.

Secondary Outcomes

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)
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 12, 16, 20, 24, 28, 32, and 36(Weeks 12, 16, 20, 24, 28, 32, and 36)
Percent Change From Baseline in SALT Score at Weeks 40, 44, and 48(Baseline to Weeks 40, 44, and 48)
Percentage of Participants Who Achieved a ≥ 50% Reduction in SALT Score From Baseline at Weeks 40, 44, and 48(Baseline to Weeks 40, 44, and 48)
Percentage of Participants Who Had an Absolute SALT Score ≤ 10 at Weeks 40, 44 and 48(Weeks 40, 44 and 48)
Percentage of Participants Who Had an Absolute SALT Score ≤ 20 at Weeks 40, 44 and 48(Weeks 40, 44 and 48)
Percentage of Participants Who Had an Absolute SALT Score ≤ 30 at Weeks 40, 44 and 48(Weeks 40, 44 and 48)
Percentage of Participants Who Had an Absolute SALT Score ≤ 50 at Weeks 40, 44 and 48(Weeks 40, 44 and 48)
Serum Concentration of Daxdilimab(Baseline: 2 hours post-dose; Weeks 4-32: Pre-dose; Weeks 36-48: Any time during the visit.)
Percent Change From Baseline in Plasmacytoid Dendritic Cell (pDC) Levels(Baseline to Weeks 4, 12, 24, 32, 36 and 48)
Number of Participants Who Experienced an Anti-drug Antibody (ADA) Response(Baseline and Weeks 4, 8, 12, 24, and 36: Pre-dose)
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)(Day 1 to Week 48)
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI)(Day 1 to Week 48)