Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02345070
• Date of registration: 19/01/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis ESTAIR
• Scientific title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study
• Date of first enrolment: May 1, 2015
• Target sample size: 327
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02345070
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Canada, Chile, Colombia, Czech Republic, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Mexico, Portugal, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria :

- Adult male or female participants.

- Documented diagnosis of IPF according to the current 2011 American Thoracic
Society/European Respiratory Society/Japanese Respiratory Society/ American Latin
Thoracic Association (ATS/ERS/JRS/ALAT) guidelines.

- Signed written informed consent.

Exclusion criteria:

- Age less than or equal to 40 years.

- IPF disease diagnosis greater than 5 years.

- Forced vital capacity (FVC) less than (<) 40 percent (%) of predicted value.

- Carbon monoxide diffusing lung capacity (DLCO) corrected for hemoglobin <30% of
predicted value.

- Severe chronic obstructive bronchitis as characterized by forced expiratory volume in
1 second /forced vital capacity (FEV1/FVC) <0.70.

- Need for 24 hours of oxygen therapy or oxygen saturation <88% after 10 minutes
breathing ambient air at rest.

- Known diagnosis of significant respiratory disorders other than IPF.

- Pulmonary artery hypertension requiring a specific treatment.

- Currently listed and/or anticipated for lung transplantation within the next 6 months
(on an active list).

- History of vasculitis or connective tissue disorders.

- Known human immunodeficiency virus or chronic viral hepatitis.

- Participants with active tuberculosis or incompletely treated latent tuberculosis
infection.

- Use of any cytotoxic/immunosuppressive agent including but not limited to
azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to
screening.

- Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab,
golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24
weeks for rituximab and 24 months for alefacept).

- Use of any investigational drug within 1 month of screening, or 5 half-lives, if known
( whichever was longer), or within 12 weeks for stem cell therapy.

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: placebo

Drug: SAR156597

Primary Outcome(s)

Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 [Time Frame: Baseline, Week 52]

Secondary Outcome(s)

Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52 [Time Frame: From randomization to disease progression (up to Week 52)]

Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52 [Time Frame: From randomization up to Week 52]

Secondary ID(s)

2014-003933-24

DRI11772

U1111-1154-6083

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02345070