Associated Skin Care Specialists | Minnesota Clinical Study Center
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About
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.
Full 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.
Acquired from Horizon in 2024.
Enrollment
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Inclusion and exclusion criteria
Key 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 discoid lupus erythematosus for ≥ 6 months prior to screening supported by a history of:
Currently active discoid lupus with all the following
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).
Males are eligible to participate if they agree to the contraceptive/barrier requirement(s).
Vaccination status should be up to date per local standards.
Key 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:
Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
Participants with positive hepatitis B serologic test results.
All participants will undergo testing for hepatitis C antibody (HCVAb) during Screening.
Participants who are HCVAb positive will be reflex tested for hepatitis C virus (HCV) RNA and if HCV RNA is positive, the participant is not eligible for the study.
Active tuberculosis (TB), or a positive interferon-gamma release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB.
Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they will be excluded.
Primary purpose
Allocation
Interventional model
Masking
99 participants in 3 patient groups, including a placebo group
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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