Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

March 23, 2022

Study Completion Date

June 13, 2022

Conditions
Scleroderma, SystemicInterstitial Lung Disease
Interventions
DRUG

Pirfenidone (PFD)

Participants will receive PFD titrated up to a target dose of 801 mg taken three times daily as tolerated (3-step titration occurring at 2 week intervals).

DRUG

Placebo (Plac)

Participants will receive a Plac, matched to resemble PFD, titrated up to a target dose of 801 mg taken three times daily as tolerated (3-step titration occurring at 2 week intervals).

DRUG

Mycophenolate Mofetil (MMF)

Participants will receive MMF titrated up to a target dose of 1500 mg taken twice daily as tolerated (4-step titration occurring at monthly intervals).

Trial Locations (16)

10021

Hospital for Special Surgery, New York

15261

University of Pittsburgh, Pittsburgh

20007

Georgetown University, Washington D.C.

21224

Johns Hopkins University, Baltimore

29425

Medical University of South Carolina, Charleston

46202

Indiana University Health, Indianapolis

48109

University of Michigan, Ann Arbor

60611

Northwestern University, Chicago

77030

University of Texas Medical School at Houston, Houston

80045

University of Colorado, Aurora

84108

University of Utah, Salt Lake City

90095

University of California Los Angeles, Los Angeles

98195

University of Washington Medical Center, Seattle

02115

Harvard Medical School, Brigham & Women's Hospital, Boston

02118

Boston University, School of Medicine, Boston

08901

Rutgers University, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Michigan

OTHER

collaborator

Genentech, Inc.

INDUSTRY

collaborator

University of California, Los Angeles

OTHER

lead

Michael Roth

OTHER