A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Hoffmann-La Roche
Study ID
NCT05075824
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Crovalimab — DRUG
    Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 kg and 100 kg) or 1500 mg IV (for participants with body weight \>= 100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, crovalimab will be administered at a dose of 680 mg SC (for participants with body weight between 40 kg and 100 kg) or 1020 mg SC (for participants with body weight \>= 100 kg). Dosing schedule will be as per Arm Description.
  • Placebo — DRUG
    Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab.

Study Details

This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.

Key Dates

Start date
Mar 9, 2022
Status verified
Apr 2026
Primary completion
Jun 11, 2025
Completion
Apr 9, 2026

Study Design

Enrollment
95 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Crovalimab
    Participants will receive a loading series of Crovalimab comprised of an intravenous (IV) loading dose on Day 1, followed by weekly Crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance SC dosing will begin at Week 5 and will continue every 4 weeks (Q4W) thereafter for a total of 48 weeks of treatment.
  • Placebo Comparator: Placebo
    Participants will receive matching Placebo administered by IV infusion and SC injection over the same duration as Crovalimab, for a total of 48 weeks of treatment.

Primary Outcome Measure

Annualized rate of medical facility VOEs (AVR) [ Time Frame: Baseline up to Week 49 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital of MichiganDetroitMichigan48201-
Mississippi Center for Advanced MedicineMadisonMississippi39110-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
East Carolina UniversityGreenvilleNorth Carolina27834-

Find similar trials in Detroit, MI

By condition
Sickle cell disease
By research site
Children's Hospital of Michigan· Detroit, MIMississippi Center for Advanced Medicine· Madison, MSIcahn School of Medicine at Mount Sinai· New York, NYEast Carolina University· Greenville, NC

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