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Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

NCT03221257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-12-15

Study results available
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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).

Conditions

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).

Sponsors & Collaborators

Principal Investigators

  • Michael D Roth, MD · Pulmonary & Critical Care Medicine, Geffen School of Medicine at UCLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2022-03-23
Completion
2022-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221257 on ClinicalTrials.gov