Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: placebo; Drug: SAR156597

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345070

2014-003933-24 (EudraCT Number)

DRI11772

U1111-1154-6083 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

Enrollment: 327 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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327 participants in 3 patient groups, including a placebo group

Placebo qw

Placebo Comparator group

Description:

Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.

Treatment:

Drug: placebo

SAR156597 200 mg q2w

Experimental group

Description:

Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.

Treatment:

Drug: placebo

Drug: SAR156597

SAR156597 200 mg qw

Experimental group

Description:

Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

Treatment:

Drug: SAR156597