aHUS Trials Watch 12a (crovalimab)

Article No. 445

13 July 2021

Hoffmann Roche has announced its pediatric trial of crovalimab for aHUS. It is featured on the ClinicalTrials.Gov website and can be found at this link HERE.

Although its status is currently “not yet recruiting” the plan is to study the effectiveness and safety of the drug on 35 children, beginning in October this year. The estimated completion date is December 2025.

There will be three study arms. Firstly those who have not been treated with a complement inhibitor before i.e. naive , those who choose to switch from eculizumab treatment and finally those have been pre treated but for whom eculizumab did not work or who have withdrawn from treatment

27 hospital locations in 11 countries have been listed where recruitment will take place including

United States, Florida
Joe DiMaggio Children’s Hospital
Hollywood, Florida, United States, 33021
United States, Nebraska
University of Nebraska; Pediatric Nephrology
Omaha, Nebraska, United States, 68198
United States, New York
SUNY at Stony Brook
Stony Brook, New York, United States, 11790
United States, Ohio
Cincinnati Children’s Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Belgium
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Brazil
Santa Casa de Belo Horizonte; Centro de Hemodiálise
Belo Horizonte, MG, Brazil, 30150-320
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu, SP, Brazil, 18618-686
Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia
Sao Paulo, SP, Brazil, 05403-900
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
China
Peking University First Hospital
Beijing City, China, 100034
Beijing Children’s Hospital, Capital Medical University
Beijing City, China, 100045
The children’s hospital , Zhejiang university school of medicine
Hangzhou, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, China, 430030
France
Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique
Montpellier, France, 34295
Gh Necker Enfants Malades; Nephrologie
Paris, France, 75743
Israel
Rambam medical Center; Pediatric Nephrology
Haifa, Israel, 3109601
Italy
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico; Nefrologia Pediatrica
Milano, Lombardia, Italy, 20122
Japan
Aichi Children’s Health and Medical Center
Aichi, Japan, 474-8710
Hiroshima Prefectural Hospital
Hiroshima, Japan, 734-8530
Yokohama City University Medical Center
Kanagawa, Japan, 232-0024
Okinawa Prefectural Nanbu Medical Center & Children’s Medical Center
Okinawa, Japan, 9011193
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy
Gdansk, Poland, 80-294
Instytut “Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii
Lodz, Poland, 93-338
Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
Warszawa, Poland, 04-730
Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii
Zabrze, Poland, 41-800
Spain
Hospital Universitario Virgen del Rocio; Servicio de Nefrologia
Sevilla, Spain, 41013

The usual study outcomes apply , the prime being  a complete TMA response by week 25  in those naive to complement inhibitor treatment. There are 23 secondary outcome measures at 25 weeks and up to 8 years. Nothing which asks the patient their views on the experience and perception  of the method and interval of treatment delivery. This drug has to be self injected, which is  novel to aHUS treatment but common in diabetes treatment.

The usual inclusion/exclusion criteria apply.

Four or eight years of data will not be needed to make an application for marketing approval of crovalimab but 25 weeks data will be needed from the last patient recruited.

Then work can be begin on revealing the outcomes in clinical publications which will take time to do but it is unlikely to be before 2023. If there is a positive outcome further time will be taken in going through licensing processes, e.g. FDA ,before health policy makers get to rule on funding it for patients,