Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus (RECAST DLE)
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- STATUS
- Recruiting
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- End date
- Dec 5, 2024
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- participants needed
- 99
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- sponsor
- Horizon Therapeutics Ireland DAC
Summary
A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.
Description
Approximately 99 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 44. After week 24 all subjects will be receiving daxbilimab, including those assigned to the placebo arm, Q4W from Week 24 to Week 44. The maximum trial duration per participant is approximately 60 weeks including screening, the 48 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Details
| Condition | Discoid Lupus Erythematosus |
|---|---|
| Treatment | Daxdilimab, Placebo/Daxdilimab |
| Clinical Study Identifier | NCT05591222 |
| Sponsor | Horizon Therapeutics Ireland DAC |
| Last Modified on | 5 September 2023 |
Eligibility
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