For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose:
This study will enroll participants aged 12 years or older with a body weight >= 40 kg diagnosed with PNH who have not been previously treated with complement inhibitor therapy. Approximately 200 participants will be randomized in a 2:1 ratio into the following regimens: [1] Crovalimab; [2] Eculizumab.
Status:
Recruiting
Study Date:
Thu, 10/08/2020 ( ) to Fri, 10/25/2024 ( )
Bone Marrow Disease(s):
- paroxysmal nocturnal hemoglobinuria (PNH)
- pediatric
Intervention:
Arm Intervention/treatment
Experimental: Arm A (Crovalimab)
Participants will receive an initial intravenous (IV) loading dose on Week 1 Day 1, followed by 4 weekly crovalimab subcutaneous (SC) doses on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter, for a total of at least 24 weeks of study treatment.
Drug: Crovalimab
Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
Active Comparator: Arm B (Eculizumab)
Participants will receive initial IV weekly doses for 4 weeks which will be followed by Q2W (every 2 weeks) IV administrations starting on Week 5.
Drug: Eculizumab
Eculizumab will be administered at a dose of 600 mg for the first 4 weeks, followed by maintenance doses of 900 mg starting on Week 5, as per the dosing schedule described above.