A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
The study treatments will be administered double-blind for 12 weeks, meaning that the
patient and study personnel will not know the identity of the treatment. Approximately 75
patients will be randomized (patients are assigned to a treatment by a chance) in a 2:1
ratio to receive siltuximab plus best supportive care (BSC) (Group A) or placebo plus BSC
(Group B). BSC includes RBC transfusion, antimicrobials, white blood cell (WBC) growth
factors, and platelet transfusions. Patients who complete 12 weeks of treatment may qualify
to receive siltuximab as open-label (identity of treatment will be known) treatment.
Treatment may continue until death, unacceptable toxicity, withdrawal of consent, or the
clinical cutoff (defined as 24 weeks after the last patient is randomized), whichever occurs
first. The study will end approximately 36 weeks after the last patient is randomized.
Patient safety will be monitored. Siltuximab and matching placebo will be supplied as a
sterile, lyophilized formulation for reconstitution and intravenous (IV) infusion. Group A:
siltuximab (15 mg/kg) administered as a 1-hour infusion every 4 weeks + BSC, or Group B:
placebo administered as a 1-hour infusion every 4 weeks + BSC.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of patients achieving a reduction in red blood cell transfusions
Reduction in red blood cell transfusions is defined by >=50% relative decrease and a >=2 unit absolute decrease in red blood cell transfusions.
8 weeks before the unblinding compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
United States: Food and Drug Administration
|Miami, Florida 33176|
|Albany, New York 12208|
|Cleveland, Ohio 44195|
|Austin, Texas 78705|
|Seattle, Washington 98195|
|Charlotte, North Carolina|