CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Pirfenidone (PFD) +2 moredrug
Likely dose
Pirfenidone (PFD) 801 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03221257
NCT03221257Phase 2Completed
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Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease

Michael Roth·interventional·Posted Jul 18, 2017·Updated Dec 15, 2023

In Brief

A Phase 2 clinical trial evaluating Pirfenidone (PFD), Placebo (Plac), and 1 other intervention for Scleroderma, Systemic and Interstitial Lung Disease. Completed, enrolled 51 participants across 16 sites.

Detailed Summary

A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Systemic, Interstitial Lung Disease
CountriesUnited States
CollaboratorsUniversity of Michigan, Genentech, Inc., University of California, Los Angeles

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 18, 2017
Enrollment StartNov 28, 2017
Primary CompletionMar 23, 2022
Study CompletionJun 13, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.0 years ago

Interventions

Pirfenidone (PFD)drug

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).

Placebo (Plac)drug

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).

Mycophenolate Mofetil (MMF)drug

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).