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Daxdilimab

Phase 2

Alopecia Areata | Monoclonal antibody | Immunology |Amgen Inc.|Last Updated: Jan 7, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05368103Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia AreataPHASE2 COMPLETED 30 — — Apr 27, 2022Jan 26, 2024Jan 7, 202513 United States, Canada
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in SALT Score at Week 24
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 Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DaxdilimabEXPERIMENTALNine sets of Daxdilimab injections over a total of 32 weeks.
Interventions
NameTypeDescription
DaxdilimabBIOLOGICALDaxdilimab will be administered subcutaneously as two injections for each dose.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Willing and able to give informed consent. 2. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. 3. Adult men or women 18 to 65 years of age. 4. Willing to keep the same hair style and color (eg, hair products, pro...

Countries:United StatesCanada
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