Universitätsklinikum Freiburg | Klinik fur Dermatologie und Venerologie
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About
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
Enrollment
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Inclusion criteria
Inclusion Criteria for the MAD Stage:
Inclusion Criteria for the OSE Stage:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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Central trial contact
Reference Study ID Number: GA43360 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
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