Roche Pharmaceutical Development and Sales Overview
Crovalimab (RG6107, SKY59)
A humanized monoclonal antibody against complement C5
Indication
Atypical hemolytic uremic syndrome (aHUS)
study 1-adults
Atypical hemolytic uremic syndrome (aHUS)
study 2 - paediatrics
Phase/study
# of patients
Phase III
COMMUTE-a
N=90
Single-arm study of aHUS patients
Cohort 1: not previously treated with C5i
"
Cohort 2: switching from C5i
Design
Cohort 3: known C5 polymorphism
■
Cohort 1+3: proportion of patients with complete TMA response anytime
between baseline and week 25
"
Primary endpoint
"
Cohort 2: proportion of patients with maintained TMA control from
baseline through week 25
"
FPI Q4 2021
Status
CT Identifier
NCT04861259
In collaboration with Chugai
aHUS=Atypical Hemolytic Uremic Syndrome; C5i-C5 inhibitor; TMA-thrombotic microangiopathy
Phase III
COMMUTE-P
N=35
Single-arm study of aHUS patients
Cohort 1: not previously treated with C5i
Cohort 2: switching from C5i ≤18y/o
Cohort 1: proportion of patients with complete TMA response anytime
between baseline and week 25
Cohort 2: proportion of patients with maintained TMA control from
baseline through week 25
FPI Q4 2021
NCT04958265
Roche
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ImmunologyView entire presentation