Daxdilimab for Alopecia Areata
Phase-Based Progress Estimates
Effectiveness
Safety
Progressive Clinical Research, San Antonio, TX
Alopecia Areata+1 More
Daxdilimab - BiologicalEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Alopecia Areata
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: Weeks 12-20; 28-36
Week 24
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 24.
Week 48
Anti-drug antibody (ADA) rate.
Change from baseline in plasmacytoid dendritic cells (pDCs).
Incidence of treatment-emergent adverse events (TEAEs), treatment-serious adverse events (TESAEs), and adverse events of special interest (AESIs).
Weeks 12-20; 28-36
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Weeks 12-20; 28-36.
Weeks 12-36
Proportion of participants who achieve ≥50% reduction in Severity of Alopecia Tool (SALT) from baseline at Weeks 12-36.
Proportion of participants with absolute Severity of Alopecia Tool (SALT) score ≤ 10, 20, 30, 50 at Weeks 12-36.
Weeks 40-48
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Weeks 40-48.
Proportion of participants who achieve ≥50% reduction in Severity of Alopecia Tool (SALT) from baseline at Weeks 40-48.
Proportion of participants with absolute Severity of Alopecia Tool (SALT) score ≤ 10, 20, 30, 50 at Weeks 40-48.
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Daxdilimab
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Daxdilimab · No Placebo Group · Phase 2
Daxdilimab
Biological
Experimental Group · 1 Intervention: Daxdilimab · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 12-20; 28-36
Closest Location: Progressive Clinical Research · San Antonio, TX
2006First Recorded Clinical Trial
4 TrialsResearching Alopecia Areata
73 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
You are a male or female aged 18 to 65 years.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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