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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01933334
• Date of registration: 23/08/2013
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) LOTUSS
• Scientific 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)
• Date of first enrolment: October 2013
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01933334
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, Italy, United States

Contacts

• Name: For additional information, call InterMune Medical Information Telephone: [phone]
• Affiliation: University of Cincinnati

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Pirfenidone

Primary Outcome(s)

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)]

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)]

Secondary Outcome(s)

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]

Secondary ID(s)

PSSc-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/09/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01933334