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.
Approximately 72 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 20. The maximum trial duration per participant is approximately 36 weeks including screening, the 24 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. Acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Placebo will be administered subcutaneously as two injections for each dose.
Daxdilimab will be administered subcutaneously as two injections for each dose.
Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24
Time frame: Baseline to Week 24
Percentage of Participants who Achieve 0 or 1 on the Cutaneous Lupus Activity-investigator's Global Assessment (CLA-IGA) scale at Week 24
CLA-IGA will be assessed by 5-point Likert Scale (0-4).
Time frame: Week 24
Percentage of Participants who Achieve a ≥ 50% Reduction in CLASI-A Score from Baseline at Week 24
Time frame: Baseline to Week 24
Mean Change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline to Week 24
Time frame: Baseline to Week 24
Serum Concentration of Daxdilimab Over Time
Time frame: Day 1 to Week 24
Percentage of Participants who Develop Anti-Drug Antibodies (ADA)
Time frame: Day 1 to Week 32
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
AEs, Serious AEs (SAEs) and AEs of Special Interest (AESIs) will be monitored. An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 1. Results in death 2. Is life-threatening. An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. An AESI may be serious or nonserious.
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Time frame: Day 1 to SFU2 (Week 32)