A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

March 17, 2021

Primary Completion Date

February 10, 2022

Study Completion Date

December 31, 2026

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
DRUG

Crovalimab

Crovalimab will be administered at a dose of 1000 milligrams (mg) IV (for participants with body weight between 40 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, 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 100 kg) or 1020 mg SC (for participants with body weight ≥ 100 kg). Dosing schedule will be as described above.

Trial Locations (4)

300020

Institute of Hematology and Hospital of Blood Disease, Tianjin

300052

Tianjin Medical University General Hospital, Tianjin

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

610041

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY