The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
The Alfred Hospital - Professor Stuart Roberts' Clinic - The Alfred Centre Location
Melbourne, Victoria, Australia
Toronto General Hospital
Toronto, Ontario, Canada
Time to Relapse for RO7049665 7.5 mg Versus Placebo
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: From randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)
Change From Baseline in Alanine Aminotransferase (ALT)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to end of the study (up to approximately 25 months)
Change From Baseline in Aspartate Aminotransferase (AST)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to end of the study (up to approximately 25 months)
Change From Baseline in Immunoglobulin G (IgG)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to end of the study (up to approximately 25 months)
Time to Relapse for RO7049665 3.5 mg Versus Placebo
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: From Randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)
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Universite de Montreal - Centre Hospitalier de l'Universite de Montreal CHUM - Hopital Saint-Luc
Montreal, Quebec, Canada
Martin Zeitz Centrum für Seltene Erkrankungen ZSE Hamburg
Hamburg, Germany
IRCCS Saverio De Bellis; Anatomia Patologica
Castellana Grotte, Apulia, Italy
Ospedale San Gerardo
Monza, Lombardy, Italy
Amsterdam UMC - location AMC
Amstermdam, Netherlands
Radboud Universiteit - Radboud Universitair Medisch Centrum Radboudumc
Nijmegen, Netherlands
Centro Hospitalar de Vila Real
Vila Real, Portugal
Pusan National University Hospital; division of pulmonology
Busan, South Korea
...and 4 more locations
Percentage of Participants With Adverse Events (AEs)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to end of the study (up to approximately 25 months)
Number of Participants With Anti-drug Antibody (ADA) Emergence and Neutralizing Potential
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to end of the study (up to approximately 25 months)