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)

Who is this study for? Adult and adolescent participants with atypical hemolytic uremic syndrome
What treatments are being studied? Crovalimab
Status: Active_not_recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Body weight \>= 40 kg at screening.

• Vaccination against Neisseria meningitidis serotypes A, C, W, and Y; vaccination against serotypes B, according to national vaccination recommendations.

• Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae, according to national vaccination recommendations.

• For participants continuing to receive other therapies concomitantly with crovalimab (e.g., immunosuppressants, corticosteroids, mammalian target of rapamycin inhibitor (mTORi) , or calcineurin inhibitors): stable dose for \>=28 days prior to screening and up to the first crovalimab administration.

• For female participants of childbearing potential: an agreement to remain abstinent or use contraception.

• Female participants of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of crovalimab.

• Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant.

• Onset of initial TMA presentation within 28 days prior to the first dose of crovalimab (for Naive Cohort only).

• Documented treatment with either eculizumab or ravulizumab (for Switch Cohort only).

• Clinical evidence of response to a C5 inhibitor (for Switch Cohort only).

• Known C5 polymorphism (for C5 SNP Cohort only).

• Poorly controlled TMA following treatment with another C5 inhibitor (for C5 SNP Cohort only).

Locations
United States
California
Univ of CA San Francisco
San Francisco
Colorado
Children's Hospital Colorado
Aurora
Georgia
Emory Children's Center
Atlanta
Missouri
Washington University
St Louis
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
The Ohio State University Wexner Medical Center
Columbus
Texas
UT Health Science Center
San Antonio
Other Locations
Belgium
UZ Leuven Gasthuisberg
Leuven
Brazil
Santa Casa de Misericordia
Belo Horizonte
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu
Hospital das Clinicas - FMUSP
São Paulo
Canada
Vancouver General Hospital
Vancouver
China
Peking University First Hospital
Beijing
France
Hôpital Arnaud de Villeneuve
Montpellier
Hopital Lapeyronie
Montpellier
Gh Necker Enfants Malades
Paris
Hôpital Robert Debré
Paris
Hopital Tenon
Paris
Germany
Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne
Klinik für Nephrologie des Universitätsklinikum Essen
Essen
Universitätsklinikum Essen
Essen
Medizinische Hochschule Hannover
Hanover
Hungary
Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely
Budapest
India
Medanta-The Medicity
Gurgaon
All India Institute Of Medical Sciences (AIIMS)
New Delhi
Israel
Rambam Medical Center
Haifa
Rabin Medical Center
Petah Tikva
Sheba MC
Ramat Gan
Italy
A.O. Universitaria S. Martino Di Genova
Genoa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
Japan
Nagoya University Hospital
Aichi
Saitama Medical University Hospital
Saitama
The University of Tokyo Hospital
Tokyo
Mexico
Hospital General de México
Distrito Federal
Instituto Nacional de Ciencias
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey
Hospital de Especialidades Puerta de Hierro S.A de C.V.
Zapopan
Poland
Instytut ?Centrum Zdrowia Matki Polki
Lodz
Spain
Hospital Clinic i Provincial
Barcelona
Hospital Universitario Virgen del Rocío
Seville
Turkey
Istanbul University Istanbul Medical Faculty
Istanbul
Kocaeli University Medical Faculty
Kocaeli
Necmettin Erbakan University Meram Medical Faculty
Konya
Malatya Park Hospital
Malatya
Time Frame
Start Date: 2021-10-22
Completion Date: 2029-08-20
Participants
Target number of participants: 83
Treatments
Experimental: Crovalimab
Participants will be enrolled in three cohorts: \[1\] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; \[2\] Switch Cohort - participants who switch to crovalimab from another Complement Component 5 (C5) inhibitor and \[3\] C5 Single Nucleotide Polymorphism (C5 inhibitor) Cohort - participants with documented C5 polymorphism.
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical

This content was sourced from clinicaltrials.gov