ClinicalTrials.gov recorded primary completion on 2022-11-16 for a phase 3 study of crovalimab, also known as Piasky, versus eculizumab in participants with paroxysmal nocturnal hemoglobinuria (PNH) who had not previously received complement inhibitor therapy. The study enrolled 210 participants and was listed as active, not recruiting. Reported measurements showed transfusion avoidance in 65.7% of participants receiving crovalimab and 68.1% receiving eculizumab.

Background

The trial evaluated crovalimab in PNH, a condition characterized in the study record as the target indication. Crovalimab was compared with eculizumab in participants who had not previously been treated with complement inhibitor therapy. The supplied data identify the medicines and condition but do not provide additional drug-class or mechanism details.

Trial design

This was a phase 3 study listed under PNH, with 210 participants and two intervention arms: crovalimab and eculizumab. Its stated purpose was to evaluate whether crovalimab was non-inferior to eculizumab in participants with PNH who had not previously received complement inhibitor therapy. No primary outcome measures were listed in the supplied record, although multiple key measurements and analyses were reported.

Key results

Transfusion avoidance was reported for 65.7% of participants in the crovalimab arm and 68.1% in the eculizumab arm. The listed weighted difference in proportion was -2.8 percentage points, with a 95% confidence interval of -15.67 to 11.14. An odds ratio was reported as 1.02, with a 95% confidence interval of 0.57 to 1.82.

Hemolysis control measured by LDH was reported in 79.3% of participants receiving crovalimab and 79.0% receiving eculizumab. Breakthrough hemolysis occurred in 10.4% and 14.5% of participants, respectively. Hemoglobin stabilization was reported in 63.4% of the crovalimab group and 60.9% of the eculizumab group.

The record also listed two sets of FACIT-F fatigue changes. One set showed means of 36.02 with a standard error of 0.877 for crovalimab and 35.09 with a standard error of 1.408 for eculizumab. Another showed means of 7.79 and 5.15, with standard errors of 0.661 and 0.880, respectively. A listed difference in adjusted mean was 2.64, with a 95% confidence interval of 0.68 to 4.6. Other weighted differences in proportion were -3.9, with a 95% confidence interval of -14.82 to 5.26, and 2.2, with a 95% confidence interval of -11.37 to 16.31.

What this means

The posted measurements showed broadly similar results between crovalimab and eculizumab across transfusion avoidance, LDH-based hemolysis control, breakthrough hemolysis, and hemoglobin stabilization. The record did not supply p-values, named outcome mappings for every analysis, or an adverse-event summary. These results describe the reported group measurements but, without the missing outcome context, do not independently establish comparative safety or efficacy beyond the study’s stated non-inferiority objective.

Source

This article is based on the ClinicalTrials.gov study record for the phase 3 trial, with primary completion recorded on 2022-11-16. The source document is available at clinicaltrials.gov.