Phase 2
N=63
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01933334 ↗Enrolled (actual)
63
Serious AEs
4.8%
Results posted
Sep 2015
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) — 96.9; 96.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pirfenidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) |
96.9; 96.8 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) |
9.4; 0.0 | — |
| SECONDARY University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores |
0.3398; 0.3347; 0.4727; 0.3548; 0.1328; 0.0202 | — |
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 Criteria
Inclusion Criteria
- 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 ( =) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) >=40% of the predicted value
- At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate
Exclusion Criteria
- Clinically significant pulmonary hypertension
- Known underlying liver disease
- Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux
- History of clinically significant asthma or chronic obstructive pulmonary disease
- Active infection
- Diagnosis of another connective tissue disorder
- Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention
- History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)
- Pregnancy or lactation
- Creatinine clearance <40 milliliters per minute (mL/min)
- Prior use of pirfenidone
- Unsuitable for enrollment or unlikely to comply with study requirements
Data sourced from ClinicalTrials.gov (NCT01933334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.