Phase 2
N=327
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02345070 ↗Enrolled (actual)
327
Serious AEs
30.5%
Results posted
May 2020
Primary outcome: Primary: Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 — -5.81; -5.24; -6.31 percent predicted FVC — p== 0.6339
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAR156597 (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 |
-5.81; -5.24; -6.31 | = 0.6339 |
| SECONDARY Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52 |
0.512; 0.460; 0.537 | — |
| SECONDARY Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52 |
0.09; 0.08; 0.13 | — |
Summary
Primary Objective:
To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).
Secondary Objectives:
To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.
To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02345070). 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.