A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants with Moderate-to-Severe Primary Discoid Lupus Erythematosus
Recruiting
99 years or below
All
Phase
2
4 participants needed
1 Location
Brief description of study
PURPOSE:
Phase 2 study to evaluate effect of daxdilimab vs placebo to reduce DLE activity in adults 18-75 yo with DLE. 60 wks 99 pts multiple sites 3 trx grps: placebo; daxdilimab 150 mg; daxdilimab 300 mg. Randomize 1:1:1 sc injections q 4 wks Screening--4 wks; Treatment--48 wks; Follow-Up--8 wks. Check eligibility, ICF signed, meds, ECG, vital signs, PEs, safety + specialty+ research labs, skin swab, pregnancy testing, clinical assessments, questionnaires, photos, optional future, genetic research.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 99 years or below
-
Gender: All
Updated on
12 Apr 2023.
Study ID: 852348