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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Discoid Lupus Erythematosus
- Sponsor
- Amgen
- Enrollment
- 99
- Locations
- 68
- Primary Endpoint
- Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24
- Status
- Terminated
- Last Updated
- 6 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to understand and provide written informed consent.
- •Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- •A diagnosis of DLE for ≥ 6 months prior to screening supported by a history of:
- •A biopsy or
- •a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale.
- •Currently active discoid lupus with all the following:
- •Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
- •CLASI-A score ≥ 8 related to discoid lesions at Baseline.
- •Treatment refractory DLE defined as active disease despite current or historical treatment with a systemic treatment.
- •Females are eligible to participate if they are not pregnant or breastfeeding, and meet the contraceptive/barrier requirement(s).
Exclusion Criteria
- •Participation in another clinical study with an investigational drug within 4 weeks prior to Randomization or within 5 published half-lives, whichever is longer.
- •Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of participant safety or trial results.
- •Weight \> 160 kg (352 pounds) at Screening.
- •History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobin (Ig) therapy.
- •Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the informed consent form (ICF) through 6 months after receiving the last dose of IP.
- •Splenectomy.
- •Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening through randomization.
- •History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities.
- •History of cancer within the past 5 years, except as follows:
- •Cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
Arms & Interventions
Placebo
Administration of placebo Q4W from Day 1 through Week 20.
Intervention: Placebo
Daxdilimab; Low Dose
Administration of daxdilimab low dose Q4W from Day 1 through Week 20.
Intervention: Daxdilimab
Daxdilimab; High Dose
Administration of daxdilimab high dose Q4W from Day 1 through Week 20.
Intervention: Daxdilimab
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Percentage of Participants who Achieve 0 or 1 on the Cutaneous Lupus Activity-investigator's Global Assessment (CLA-IGA) scale at Week 24(Week 24)
- Percentage of Participants who Achieve a ≥ 50% Reduction in CLASI-A Score from Baseline at Week 24(Baseline to Week 24)
- Mean Change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline to Week 24(Baseline to Week 24)
- Serum Concentration of Daxdilimab Over Time(Day 1 to Week 24)
- Percentage of Participants who Develop Anti-Drug Antibodies (ADA)(Day 1 to Week 32)
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Day 1 to SFU2 (Week 32))