CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 210 enrolled
Drug / intervention
Crovalimab +1 moredrug
Likely dose
Crovalimab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04434092
NCT04434092Phase 3Active
CompareCT.gov

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Hoffmann-La Roche·interventional·Posted Jun 16, 2020·Updated Apr 28, 2026

In Brief

A Phase 3 clinical trial evaluating Crovalimab and Eculizumab for Paroxysmal Nocturnal Hemoglobinuria. Active but no longer recruiting, targeting 210 participants across 61 sites in 23 countries.

Detailed Summary

A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesArgentina, Brazil, China, France, Germany, Greece, Japan, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
CollaboratorsChugai Pharmaceutical

Timeline

Phase 3Active
2021202220232024202520262027
First PostedJun 16, 2020
Enrollment StartOct 8, 2020
Primary CompletionNov 16, 2022
Study CompletionSep 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.0 years ago

Interventions

Crovalimabdrug

Dosing depends on body weight. Participants will be dosed as follows: * 5 kg to \< 12 kg: 100 mg IV on Week 1 Day 1 (W1D1); 85 mg SC on Week 1 Day 2 (W1D2) and Q2W from Week 3 until end of study * 12 kg to \< 20 kg: 200 mg IV on W1D1; 85 mg SC on W1D2, Weeks 2, 3 and 4; 170 mg SC, Q2W from Week 5 until end of study * 20 kg to \< 30 kg: 300 mg IV on W1D1; 85 mg SC on W1D2, Weeks 2, 3 and 4; 340 mg SC, Q4W from Week 5 until end of study * 30 kg to \< 40 kg: 400 mg IV on W1D1; 170 mg SC on W1D2, Weeks 2, 3 and 4; 510 mg SC, Q4W from Week 5 until end of study * 40 kg to \< 100 kg: 1000 mg IV on W1D1; 340 mg SC W1D2, Weeks 2, 3 and 4; 680 mg SC, Q4W from Week 5 until end of study * 100 kg: 1500 mg IV on W1D1; 340 mg SC W1D2, Weeks 2, 3 and 4; 1020 mg SC, Q4W from Week 5 until end of study.

Eculizumabdrug

Eculizumab will be administered as specified in the respective arm.