Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata
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ClinicalTrials.gov Identifier: NCT05368103 |
Recruitment Status :
Completed
First Posted : May 10, 2022
Last Update Posted : February 26, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | April 11, 2022 | ||||
First Posted Date ICMJE | May 10, 2022 | ||||
Last Update Posted Date | February 26, 2024 | ||||
Actual Study Start Date ICMJE | April 27, 2022 | ||||
Actual Primary Completion Date | August 7, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 24. [ Time Frame: Day 1 through Week 24. ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata | ||||
Official Title ICMJE | A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Alopecia Areata | ||||
Intervention ICMJE | Biological: Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Other Name: HZN-7734
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Study Arms ICMJE | Experimental: Daxdilimab
Nine sets of Daxdilimab injections over a total of 32 weeks.
Intervention: Biological: Daxdilimab
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | January 25, 2024 | ||||
Actual Primary Completion Date | August 7, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05368103 | ||||
Other Study ID Numbers ICMJE | HZNP-DAX-201 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Amgen | ||||
Original Responsible Party | Horizon Therapeutics Ireland DAC | ||||
Current Study Sponsor ICMJE | Amgen | ||||
Original Study Sponsor ICMJE | Horizon Therapeutics Ireland DAC | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Amgen | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |