Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

ClinicalTrials.gov ID: NCT01933334

Public ClinicalTrials.gov record NCT01933334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).

Study identification

NCT ID: NCT01933334
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Genentech, Inc.; Industry
Enrollment: 63 participants

Conditions and interventions

Conditions

Systemic Sclerosis

Interventions

Pirfenidone Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2013 (Type not available)
Primary completion: Sep 2014 (Actual)
Completion: Sep 2014 (Actual)
Last update posted: Aug 4, 2016

2013 – 2014

United States locations

U.S. sites: 18
U.S. states: 13
U.S. cities: 17

Facility	City	State	ZIP	Site status
Mayo Clinic, Scottsdale	Scottsdale	Arizona	85259	—
University of California, Los Angeles	Los Angeles	California	90095	—
Stanford University School of Medicine	Redwood City	California	94063	—
University of California, San Francisco	San Francisco	California	94143	—
National Jewish Medical and Research Center	Denver	Colorado	80206	—
Georgetown University Hospital	Washington D.C.	District of Columbia	20007	—
Northwestern University, Chicago	Chicago	Illinois	60611	—
Boston University Medical Center	Boston	Massachusetts	02118	—
University of Michigan	Ann Arbor	Michigan	48109	—
Hospital for Special Surgery	New York	New York	10021	—
Columbia University	New York	New York	10032	—
University of Cincinnati	Cincinnati	Ohio	45267	—
Cleveland Clinic Foundation	Cleveland	Ohio	44195	—
University of Toledo	Toledo	Ohio	43614	—
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15261	—
Medical University South Carolina	Charleston	South Carolina	29425	—
University of Texas, Houston	Houston	Texas	77030	—
University of Utah	Salt Lake City	Utah	84132	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01933334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 4, 2016 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01933334 live on ClinicalTrials.gov.

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