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Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria

Study acronym: COMPOSER
StatusCompleted
PhasePhase 1/2
Started2016-11-14
View on ClinicalTrials.gov ↗
This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.

Amendment history 3 changes detected by DataLookout

2026-09-02
notable
Trial completed
2026-08-06
minor
Primary completion moved earlier: 2026-09-30 → 2026-08-13
2026-08-06
minor
Completion moved earlier: 2026-09-30 → 2026-08-13
Trial Details
NCT Number NCT03157635
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Paroxysmal Hemoglobinuria, Nocturnal
Enrollment 59 participants
Start Date 2016-11-14
Primary Completion 2026-08-13 (estimated)
Study Completion 2026-08-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-01