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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

November 14, 2016

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Paroxysmal Hemoglobinuria, Nocturnal
Interventions
DRUG

Crovalimab

Crovalimab will be administered as per schedule described in individual arm.

DRUG

Placebo

Placebo will be administered as per schedule described in Part 1 placebo arm.

Trial Locations (14)

1083

Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia, Budapest

7400

Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology, Kaposvár

52074

Uniklinik RWTH Aachen, Aachen

75475

Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis, Paris

89081

Universitätsklinikum Ulm, Ulm

00168

Policlinico Universitario Agostino Gemelli, Rome

980-8574

Tohoku University Hospital, Miyagi

565-0871

Osaka University Hospital, Osaka

141-8625

NTT Medical Center Tokyo, Tokyo

160-0023

Tokyo Medical University Hospital, Tokyo

305-8576

University of Tsukuba Hospital, Tsukuba

9713 GZ

Pra International Group B.V, Groningen

03722

Severance Hospital, Yonsei University Health System, Seoul

110-744

Seoul National University Hosp, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY