--- title: Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) nct_id: NCT01933334 overall_status: COMPLETED phase: PHASE2 sponsor: Genentech, Inc. study_type: INTERVENTIONAL primary_condition: Systemic Sclerosis countries: United States, Canada, Italy canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01933334.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01933334" ct_last_update_post_date: 2016-08-04 last_seen_at: "2026-05-12T06:35:43.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) **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) **NCT ID:** [NCT01933334](https://clinicaltrials.gov/study/NCT01933334) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 63 - **Lead Sponsor:** Genentech, Inc. - **Conditions:** Systemic Sclerosis - **Start Date:** 2013-10 - **Completion Date:** 2014-09 - **CT.gov Last Update:** 2016-08-04 ## Brief Summary 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). ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (\<) 7 years 2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan 3. Screening forced vital capacity (FVC) greater than equal to (\>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) \>=40% of the predicted value 4. At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate Exclusion Criteria: 1. Clinically significant pulmonary hypertension 2. Known underlying liver disease 3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux 4. History of clinically significant asthma or chronic obstructive pulmonary disease 5. Active infection 6. Diagnosis of another connective tissue disorder 7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention 8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD) 9. Pregnancy or lactation 10. Creatinine clearance \<40 milliliters per minute (mL/min) 11. Prior use of pirfenidone 12. Unsuitable for enrollment or unlikely to comply with study requirements ``` ## Arms - **Pirfenidone: 4-Week Titration Group** (EXPERIMENTAL) — Participants will receive one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day \[mg/day\]) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks maintenance period). - **Pirfenidone: 2-Week Titration Group** (EXPERIMENTAL) — Participants will receive one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period). ## Interventions - **Pirfenidone** (DRUG) — Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period). ## Primary Outcomes - **Percentage of Participants With Treatment-Emergent Adverse Events (AEs)** _(time frame: From baseline up to 28 days after the last dose of study drug (last dose = Week 16))_ — Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. - **Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)** _(time frame: From baseline up to 28 days after the last dose of study drug (last dose = Week 16))_ — An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. ## Secondary Outcomes - **University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores** _(time frame: Baseline, Weeks 4, 8, 12, and 16)_ ## Locations (22) - Mayo Clinic, Scottsdale, Scottsdale, Arizona, United States - University of California, Los Angeles, Los Angeles, California, United States - Stanford University School of Medicine, Redwood City, California, United States - University of California, San Francisco, San Francisco, California, United States - National Jewish Medical and Research Center, Denver, Colorado, United States - Georgetown University Hospital, Washington D.C., District of Columbia, United States - Northwestern University, Chicago, Chicago, Illinois, United States - Boston University Medical Center, Boston, Massachusetts, United States - University of Michigan, Ann Arbor, Michigan, United States - Hospital for Special Surgery, New York, New York, United States - Columbia University, New York, New York, United States - University of Cincinnati, Cincinnati, Ohio, United States - Cleveland Clinic Foundation, Cleveland, Ohio, United States - University of Toledo, Toledo, Ohio, United States - University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States - Medical University South Carolina, Charleston, South Carolina, United States - University of Texas, Houston, Houston, Texas, United States - University of Utah, Salt Lake City, Utah, United States - St. Joseph's Healthcare, Hamilton, Ontario, Canada - Toronto General Hospital, Toronto, Ontario, Canada - Università di Torino, Orbassano, Turin, Italy - University of Florence, Florence, Italy ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `locations.northwestern university, chicago|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.boston university medical center|boston|massachusetts|united states` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mayo clinic, scottsdale|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.university of california, los angeles|los angeles|california|united states` — added _(2026-05-12)_ - `locations.stanford university school of medicine|redwood city|california|united states` — added _(2026-05-12)_ - `locations.university of california, san francisco|san francisco|california|united states` — added _(2026-05-12)_ - `locations.national jewish medical and research center|denver|colorado|united states` — added _(2026-05-12)_ - `locations.georgetown university hospital|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.hospital for special surgery|new york|new york|united states` — added _(2026-05-12)_ - `locations.columbia university|new york|new york|united states` — added _(2026-05-12)_ - `locations.university of cincinnati|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.cleveland clinic foundation|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.university of toledo|toledo|ohio|united states` — added _(2026-05-12)_ - `locations.university of pittsburgh medical center|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_ - `locations.medical university south carolina|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.university of texas, houston|houston|texas|united states` — added _(2026-05-12)_ - `locations.university of utah|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.st. joseph's healthcare|hamilton|ontario|canada` — added _(2026-05-12)_ - `locations.toronto general hospital|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.università di torino|orbassano|turin|italy` — added _(2026-05-12)_ - `locations.university of florence|florence||italy` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01933334.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01933334* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*