To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01529853
• Collaborator: (none)
• Enrollment: 24
• Locations: 21
• Arms: 4
• Duration (Months): 21
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objective:

To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period.

Secondary Objectives:

To assess in adult patients with IPF:

• The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.

• The trough plasma concentrations of SAR156597

• The potential immunogenicity of SAR156597.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: SAR156597; Drug: Placebo (for SAR156597)	Phase 1/Phase 2

Detailed Description

The study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. Total study duration is up to 22 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAR156597 dose 1 SAR156597 dose 1, subcutaneous injection once every week	Drug: SAR156597; Pharmaceutical form: solution Route of administration: subcutaneous
Experimental: SAR156597 dose 2 SAR156597 dose 2, subcutaneous injection once every week	Drug: SAR156597; Pharmaceutical form: solution Route of administration: subcutaneous
Experimental: SAR156597 dose 3 SAR156597 dose 3, subcutaneous injection once every week	Drug: SAR156597; Pharmaceutical form: solution Route of administration: subcutaneous
Placebo Comparator: Placebo Placebo (for SAR156597), subcutaneous injection once every week	Drug: Placebo (for SAR156597); Pharmaceutical form: solution Route of administration: subcutaneous

Outcome Measures

Primary Outcome Measures

1. Safety/tolerability: Number of participants with Adverse events [from first dose of study drug up to Week 18]

Secondary Outcome Measures

1. Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC) [from baseline to week 6]

2. Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco) [from baseline to week 6]

3. Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ) [from baseline to week 6]

4. Pharmacodynamic: Change in plasma levels of biomarkers [from baseline to week 18]

5. Pharmacokinetic: SAR156597 plasma concentration [from baseline to week 18]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Adult (aged >18 years) male or female patients,

• Documented diagnosis of IPF according to the current American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/American Latin Thoracic Association (ATS/ERS/JRS/ALTA) guidelines

Exclusion criteria:

• Forced vital capacity (FVC) <50% of predicted value Carbon monoxide diffusing lung capacity (DLCO) (corrected for hemoglobin) <35% predicted value

• Oxygen saturation <90% by pulse oximetry while breathing ambient air at rest (sitting position for 10 min)

• Known diagnosis of significant respiratory disorders other than IPF

• Active vasculopathy or use of vasoactive drugs

• Known HIV or chronic viral hepatitis

• Patients with active tuberculosis or latent tuberculosis infection

• Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical (other than IPF) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator

• Clinically significant abnormal ECG at screening

• Clinically significant laboratory tests at screening

• Current history of substance and/or alcohol abuse

• Females who are lactating or who are pregnant.

• Use of any registered therapy targeted to treat IPF within 4 weeks prior to screening

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 840008	Sacramento	California	United States	95817
2	Investigational Site Number 840009	Jacksonville	Florida	United States	32209
3	Investigational Site Number 840011	Jacksonville	Florida	United States	32216
4	Investigational Site Number 840006	Chicago	Illinois	United States	60637
5	Investigational Site Number 840004	Joliet	Illinois	United States	60435
6	Investigational Site Number 840005	Maywood	Illinois	United States	60153
7	Investigational Site Number 840002	Wichita	Kansas	United States	67208
8	Investigational Site Number 840003	Minneapolis	Minnesota	United States	55455
9	Investigational Site Number 840013	New York	New York	United States	10021
10	Investigational Site Number 840014	Cincinnati	Ohio	United States	45267-0542
11	Investigational Site Number 840010	Charleston	South Carolina	United States	29406
12	Investigational Site Number 124003	Edmonton		Canada	T6G 2B7
13	Investigational Site Number 124001	Hamilton		Canada	L8N 4A6
14	Investigational Site Number 124002	Vancouver		Canada	V5Z 1M9
15	Investigational Site Number 152003	Santiago		Chile	750-0691
16	Investigational Site Number 152001	Santiago		Chile	7500710
17	Investigational Site Number 152002	Santiago		Chile	8380456
18	Investigational Site Number 484003	Mexico City		Mexico	40766
19	Investigational Site Number 484002	Monterrey		Mexico	64460
20	Investigational Site Number 724001	Barcelona		Spain	08036
21	Investigational Site Number 724002	Barcelona		Spain	08907

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01529853
• Other Study ID Numbers: TDR11326; 2011-005481-37; U1111-1124-1425
• First Posted: Feb 9, 2012
• Last Update Posted: Feb 15, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Feb 15, 2016