Riociguat in Scleroderma Associated Digital Ulcers

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

July 24, 2018

Study Completion Date

July 24, 2018

Conditions
SclerodermaDigital Ulcers
Interventions
DRUG

Riociguat

riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)

DRUG

Placebo

Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;

Trial Locations (5)

10035

Hospital of Special Surgery (HSS), New York

15261

University of Pittsburgh, Pittsburgh

20007

Georgetown University, Washington D.C.

48109

University of Michigan, Ann Arbor

84132

University of Utah, Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Dinesh Khanna, MD, MS

OTHER

NCT02915835 - Riociguat in Scleroderma Associated Digital Ulcers | Biotech Hunter | Biotech Hunter