Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Scleroderma, Systemic

In brief

To investigate if Riociguat is effective in the treatment of systemic sclerosis

Key facts

Study ID

NCT02283762

Run by

Bayer

People needed

121

Starts

2015-01-15

Expected to finish

2019-03-28

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 years and older
• Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria
• dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
• Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation)
• ≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit
• FVC (forced vital capacity) ≥ 45% of predicted at screening
• DLCO (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening
• Negative serum pregnancy test in a woman of childbearing potential at the screening visit
• Women of childbearing potential must agree to use adequate contraception when sexually active. "Adequate contraception" is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration.

You may not qualify if…

• Limited cutaneous SSc (systemic sclerosis) at screening
• Major surgery (including joint surgery) within 8 weeks prior to screening
• Hepatic insufficiency classified as Child-Pugh C
• Patients with isolated AST or ALT >3xULN or bilirubin >2xULN can be included in the trial under the condition of additional monitoring during the trial
• Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m\^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m\^2 will be undergo additional monitoring of renal function
• Any prior history of renal crisis
• Sitting SBP (systolic blood pressure) < 95 mmHg at the screening visit
• Sitting heart rate < 50 beats per minute (BPM) at the screening visit
• Left ventricular ejection fraction < 40% prior to screening
• Any form of pulmonary hypertension as determined by right heart catheterization
• Pulmonary disease with FVC < 45% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening
• Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
• Not permitted prior and concomitant medication
• Pregnant or breast feeding women
• Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.

Where it is running

• UCLA David Geffen School of Medicine — Los Angeles, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Medical University of South Carolina Medical Center — Charleston, South Carolina, United States
• Memorial Hermann-Texas Medical Center — Houston, Texas, United States
• University of Utah Health Care — Salt Lake City, Utah, United States
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• St Vincent's Hospital — Fitzroy, Victoria, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• CU Saint-Luc/UZ St-Luc — Bruxelles - Brussel, Belgium
• UZ Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• St. Joseph's Healthcare - Hamilton — Hamilton, Ontario, Canada
• Arthritis Program Research Group, Inc. — Newmarket, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Sir Mortimer B. Davis Jewish General Hospital — Montreal, Quebec, Canada
• Revmatologicky ustav — Prague, Czechia
• Hôpital Pellegrin - Bordeaux — Bordeaux, France
• Centre Hospitalier Universitaire - Grenoble — Grenoble, France
• Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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