Trial Condition(s):

Scleroderma, Systemic

Efficacy and safety of Riociguat in patients with systemic sclerosis

Bayer Identifier:

16277

ClinicalTrials.gov Identifier:

NCT02283762

EudraCT Number:

2014-001353-16

Study Completed

Trial Purpose

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

Inclusion Criteria
- 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.
Exclusion Criteria
- 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.

Trial Summary

Enrollment Goal
121
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Revmatologicky ustav

Praha 2, Czech Republic, 128 50

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50139

Status
Completed
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

A.O.U. di Cagliari

Cagliari, Italy, 09042

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

St Vincent's Hospital

Fitzroy, Australia, 3065

Status
Completed
 
Locations

Monash Medical Centre

Clayton, Australia, 3168

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, Turkey, 34093

Status
Completed
 
Locations

Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50937

Status
Completed
 
Locations

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Status
Completed
 
Locations

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany, 61231

Status
Completed
 
Locations

Royal Perth Hospital

Perth, Australia, 6000

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

Nijmegen, Netherlands, 6525 GA

Status
Completed
 
Locations

University Medical Center Utrecht

Utrecht, Netherlands, 3584 CX

Status
Completed
 
Locations

UniversitätsSpital Zürich

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Hope Hospital

Salford, United Kingdom, M6 8HD

Status
Completed
 
Locations

Aintree University Hospital

Liverpool, United Kingdom, L9 7AL

Status
Completed
 
Locations

Hopital Claude-Huriez CHRU

LILLE, France, 59037

Status
Completed
 
Locations

Centre Hospitalier Universitaire - Grenoble

GRENOBLE, France, 38043

Status
Completed
 
Locations

Stanford University School of Medicine

Palo Alto, United States, 94304

Status
Completed
 
Locations

University of Utah Health Care

Salt Lake City, United States, 84132

Status
Completed
 
Locations

UCLA David Geffen School of Medicine

Los Angeles, United States, 90095-1670

Status
Completed
 
Locations

Mayo Clinic - Scottsdale

Scottsdale, United States, 85259-5404

Status
Completed
 
Locations

Rutgers Robert Wood Johnson Medical School

New Brunswick, United States, 08901

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Georgetown University Medical Center

Washington, United States, 20007

Status
Completed
 
Locations

Memorial Hermann-Texas Medical Center

Houston, United States, 77030

Status
Completed
 
Locations

Arthritis Program Research Group, Inc.

Newmarket, Canada, L3Y 3R7

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland

Status
Completed
 
Locations

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Status
Completed
 
Locations

Tohoku University Hospital

Sendai, Japan, 980-8574

Status
Completed
 
Locations

Institute of Rheumatology Tokyo Women's Medical University

Shinjuku-ku, Japan, 162-0054

Status
Completed
 
Locations

Nippon Medical School Hospital

Bunkyo-ku, Japan, 113-8603

Status
Completed
 
Locations

University of Connecticut Health Center

Farmington, United States, 06030

Status
Completed
 
Locations

Medical University of South Carolina Medical Center

Charleston, United States, 29425

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T1E2

Status
Completed
 
Locations

Mount Sinai Hospital

Toronto, Canada, M5T 3L9

Status
Completed
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7632

Status
Completed
 
Locations

Cochin - Paris

PARIS, France, 75674

Status
Completed
 
Locations

CHU STRASBOURG - Hôpital de Hautepierre

STRASBOURG, France, 67098

Status
Completed
 
Locations

Hôpital Pellegrin - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

St. Joseph's Healthcare - Hamilton

Hamilton, Canada, L8N 1Y2

Status
Completed
 
Locations

Gunma University Hospital

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Status
Completed
 
Locations

Liverpool Hospital

Liverpool, Australia, 2170

Status
Active, not recruiting
 
Locations

Wellington Hospital

Wellington, New Zealand, 6021

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89081

Status
Completed
 
Locations

Cukurova Univ. Tip. Fak. Balcali Hastanesi

Adana, Turkey, 01330

Status
Completed
 
Locations

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, Turkey, 35340

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Completed
 

Trial Design