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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
Stanford University
Palo Alto, California, United States
Hospital For Special Surgery
New York, New York, United States
Metroplex Clinical Research Centre
Dallas, Texas, United States
Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.
Buenos Aires, Argentina
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Argentina
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
La Tronche, France
Hopital Cochin
Paris, France
CHU de Bordeaux
Pessac, France
CHRU Rennes
Rennes, France
...and 15 more locations
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Time frame: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Up to approximately 17 months
MAD Stage: Maximum Serum Concentration (Cmax) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or early termination (ET) visit
MAD Stage: Area Under the Concentration vs Time Curve (AUC) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Time to Maximum Concentration (Tmax) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Total Clearance (CL) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Volume of Distribution (V) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Half-Life (t1/2) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD and OSE Stage: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7303509
Time frame: MAD Stage: Predose on Day 1 and at multiple timepoints up to Day 113 (Week 16) or ET visit; OSE Stage: Predose and multiple timepoints up to Week 52; (up to approximately 1.3 years)
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