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Crovalimab

DRUG20 trials

Sponsors

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd, Hoffmann-La Roche, Roche

Conditions

Antiphospholipid SyndromeAtypical Hemolytic Uremic SyndromeAtypical Hemolytic Uremic Syndrome (aHUS)Guillain-Barré SyndromeHaematological DisordersParoxysmal Hemoglobinuria, NocturnalParoxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria (PNH)

Phase 1

Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria
Active, not recruitingNCT03157635
Hoffmann-La RocheParoxysmal Hemoglobinuria, Nocturnal
Start: 2016-11-14End: 2026-09-30Updated: 2026-02-17
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).
CompletedNCT04912869
Hoffmann-La RocheSickle Cell Disease
Start: 2022-03-26End: 2025-08-15Updated: 2025-08-26
A Phase IB, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso‑Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)
CompletedCTIS2022-502546-26-00
F. Hoffmann-La Roche AGSickle Cell Disease
Start: 2023-09-11End: 2025-05-26Target: 16Updated: 2025-08-18
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD). (CROSSWALK-a)
RecruitingPACTR202308825367505
RocheHaematological Disorders
Start: 2022-03-26Target: 30Updated: 2026-01-27
AN ADAPTIVE PHASE I/II STUDY TO ASSESS SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7112689 IN HEALTHY VOLUNTEERS AND PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
Active, not recruitingCTIS2023-506287-14-00
F. Hoffmann-La Roche AGParoxysmal nocturnal hemoglobinuria (PNH)
Start: 2017-04-21Target: 19Updated: 2025-08-07
Crosswalk-a
RecruitingLBCTR2024045330
F. Hoffmann-La Roche LtdThis study is tackling the management of acute uncomplicated vaso occlusive episodes (voe) in patients with sickle cell disease (SCD). This study will enroll approximately 30 patients (at approximately 10-15 sites globally), aged 12-55 years old and =40 kg, with sickle cell disease genotype of HbSS or HbSß0, presenting to the ER/ED or acute medical facility with an acute uncomplicated vaso-occulsive episodes. sickle cell disease
Start: 2022-03-26Target: 30Updated: 2026-02-02

Phase 2

Phase 3

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Active, not recruitingNCT04432584
Hoffmann-La RocheParoxysmal Nocturnal Hemoglobinuria
Start: 2020-09-30End: 2027-09-30Target: 190Updated: 2026-01-28
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
Active, not recruitingNCT04434092
Hoffmann-La RocheParoxysmal Nocturnal Hemoglobinuria
Start: 2020-10-08End: 2027-09-30Updated: 2026-02-17
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition
Active, not recruitingNCT04654468
Hoffmann-La RocheParoxysmal Nocturnal Hemoglobinuria
Start: 2021-03-17End: 2026-12-31Updated: 2026-02-11
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Active, not recruitingNCT04861259
Hoffmann-La RocheAtypical Hemolytic Uremic Syndrome
Start: 2021-10-22End: 2029-08-20Updated: 2026-01-22
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Active, not recruitingNCT04958265
Hoffmann-La RocheAtypical Hemolytic Uremic Syndrome
Start: 2021-11-17End: 2029-05-19Updated: 2026-03-27
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)
WithdrawnNCT05494619
Hoffmann-La RocheGuillain-Barré Syndrome
Start: 2022-11-30End: 2026-09-30Updated: 2022-12-15
A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
RecruitingCTIS2023-505638-82-00
F. Hoffmann-La Roche AGAtypical Hemolytic Uremic Syndrome (aHUS)
Start: 2022-01-12Target: 9Updated: 2026-01-19
A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients with atypical Hemolytic Uremic Syndrome (aHUS)
Active, not recruitingCTIS2023-505089-27-00
F. Hoffmann-La Roche AGAtypical Hemolytic Uremic Syndrome (aHUS)
Start: 2021-07-01Target: 19Updated: 2026-01-26
A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS
Active, not recruitingCTIS2023-506526-37-00
F. Hoffmann-La Roche AGParoxysmal Nocturnal Hemoglobinuria (PNH)
Start: 2021-03-17Target: 77Updated: 2026-01-09
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
Active, not recruitingCTIS2023-506498-36-00
F. Hoffmann-La Roche AGParoxysmal Nocturnal Hemoglobinuria (PNH)
Start: 2021-04-08Target: 42Updated: 2025-12-01

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