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

NCT02345070 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: DRI117722014-003933-24U1111-1154-6083
• Study Type: interventional
• Target: 327
• Locations: 19 countries
• Sites: 101

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52

  FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.

  Baseline, Week 52

Secondary Outcomes (2)

• Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52

  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

  From randomization up to Week 52

Study Arms (3)

Placebo qw

PLACEBO COMPARATOR

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

Drug: placebo

SAR156597 200 mg q2w

EXPERIMENTAL

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

Drug: SAR156597; Drug: placebo

SAR156597 200 mg qw

EXPERIMENTAL

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

Drug: SAR156597

Interventions

SAR156597 DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

SAR156597 200 mg q2w; SAR156597 200 mg qw

placebo DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo qw; SAR156597 200 mg q2w

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (101)

Investigational Site Number 840003

Phoenix, Arizona, 85006, United States

Location

Investigational Site Number 840020

Jacksonville, Florida, 32209, United States

Location

Investigational Site Number 840022

Loxahatchee Groves, Florida, 33470, United States

Location

Investigational Site Number 840017

Atlanta, Georgia, 30322, United States

Location

Investigational Site Number 840008

Decatur, Georgia, 30033, United States

Location

Investigational Site Number 840010

Louisville, Kentucky, 40218, United States

Location

Investigational Site Number 840009

Minneapolis, Minnesota, 55455, United States

Location

Investigational Site Number 840006

Rochester, Minnesota, 55905, United States

Location

Investigational Site Number 840026

Chesterfield, Missouri, 63017, United States

Location

Investigational Site Number 840001

Lebanon, New Hampshire, 03756, United States

Location

Investigational Site Number 840002

Summit, New Jersey, 07901, United States

Location

Investigational Site Number 840015

Jamaica, New York, 11435, United States

Location

Investigational Site Number 840023

Mineola, New York, 11501, United States

Location

Investigational Site Number 840012

New York, New York, 10016, United States

Location

Investigational Site Number 840013

Stony Brook, New York, 11794-8121, United States

Location

Investigational Site Number 840014

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 840011

Dallas, Texas, 75390, United States

Location

Investigational Site Number 840024

Everett, Washington, 98208, United States

Location

Investigational Site Number 032009

Caba, C1414AIF, Argentina

Location

Investigational Site Number 032005

Caba, C1425FVH, Argentina

Location

Investigational Site Number 032001

La Plata, B1900DXM, Argentina

Location

Investigational Site Number 032004

Mendoza, 5500, Argentina

Location

Investigational Site Number 032002

San Miguel de Tucumán, T4000IAR, Argentina

Location

Investigational Site Number 032007

Vicente López, 1602, Argentina

Location

Investigational Site Number 036005

Camperdown, 2050, Australia

Location

Investigational Site Number 036004

Darlinghurst, 2010, Australia

Location

Investigational Site Number 036002

Frankston, 3199, Australia

Location

Investigational Site Number 036003

Murdoch, 6150, Australia

Location

Investigational Site Number 036001

Nundah, 4012, Australia

Location

Investigational Site Number 124003

Toronto, M5G 2N2, Canada

Location

Investigational Site Number 124002

Vancouver, V5Z 1M9, Canada

Location

Investigational Site Number 152003

Quillota, 2260877, Chile

Location

Investigational Site Number 152001

Santiago, 750-0691, Chile

Location

Investigational Site Number 152004

Santiago, 7500698, Chile

Location

Investigational Site Number 152006

Santiago, 8380456, Chile

Location

Investigational Site Number 152002

Talca, 3460001, Chile

Location

Investigational Site Number 152007

Viña del Mar, Chile

Location

Investigational Site Number 170004

Armenia, 630004, Colombia

Location

Investigational Site Number 170001

Bogotá, 110121, Colombia

Location

Investigational Site Number 170005

Cali, Colombia

Location

Investigational Site Number 203002

Hradec Králové, 50005, Czechia

Location

Investigational Site Number 203004

Olomouc, 77900, Czechia

Location

Investigational Site Number 203003

Prague, 12808, Czechia

Location

Investigational Site Number 203001

Prague, 14059, Czechia

Location

Investigational Site Number 208002

Aarhus C, 8000, Denmark

Location

Investigational Site Number 208001

Hellerup, 2900, Denmark

Location

Investigational Site Number 250007

Bobigny, France

Location

Investigational Site Number 250002

Lille, 59037, France

Location

Investigational Site Number 250001

Lyon, 69394, France

Location

Investigational Site Number 250009

Marseille, 13015, France

Location

Investigational Site Number 250005

Montpellier, 34295, France

Location

Investigational Site Number 250004

Nice, 6002, France

Location

Investigational Site Number 250006

Paris, 75018, France

Location

Investigational Site Number 250008

Toulouse, 31059, France

Location

Investigational Site Number 250003

Tours, France

Location

Investigational Site Number 276003

Coswig, 01640, Germany

Location

Investigational Site Number 276002

Donaustauf, 93093, Germany

Location

Investigational Site Number 276004

Giessen, 35392, Germany

Location

Investigational Site Number 276005

Hanover, 30625, Germany

Location

Investigational Site Number 276001

Heidelberg, 69126, Germany

Location

Investigational Site Number 300001

Heraklion, 71110, Greece

Location

Investigational Site Number 376001

Haifa, 34362, Israel

Location

Investigational Site Number 376004

Kfar Saba, 44281, Israel

Location

Investigational Site Number 376002

Petah Tikva, 49100, Israel

Location

Investigational Site Number 376005

Rehovot, 76100, Israel

Location

Investigational Site Number 376003

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 380003

Catania, 95123, Italy

Location

Investigational Site Number 380001

Forlì, 47121, Italy

Location

Investigational Site Number 380005

Milan, 20123, Italy

Location

Investigational Site Number 380002

Orbassano, 10043, Italy

Location

Investigational Site Number 380006

Pisa, 56124, Italy

Location

Investigational Site Number 380004

Siena, 53100, Italy

Location

Investigational Site Number 484002

Mexico City, 14050, Mexico

Location

Investigational Site Number 484001

Monterrey, 64460, Mexico

Location

Investigational Site Number 484005

Monterrey, 66465, Mexico

Location

Investigational Site Number 484003

San Juan del Río, 76800, Mexico

Location

Investigational Site Number 620003

Porto, 4200-319, Portugal

Location

Investigational Site Number 620004

Vila Nova de Gaia, 4400, Portugal

Location

Investigational Site Number 410005

Bucheon-si, 14584, South Korea

Location

Investigational Site Number 410001

Incheon, 21565, South Korea

Location

Investigational Site Number 410006

Seongnam, 463-707, South Korea

Location

Investigational Site Number 410002

Seoul, 02841, South Korea

Location

Investigational Site Number 410003

Seoul, 110-744, South Korea

Location

Investigational Site Number 410004

Seoul, South Korea

Location

Investigational Site Number 724003

Barcelona, 08035, Spain

Location

Investigational Site Number 724002

Barcelona, 08036, Spain

Location

Investigational Site Number 724001

L'Hospitalet de Llobregat, 08907, Spain

Location

Investigational Site Number 724004

Lugo, 27003, Spain

Location

Investigational Site Number 724006

Majadahonda, 28222, Spain

Location

Investigational Site Number 724005

Palma de Mallorca, 07120, Spain

Location

Investigational Site Number 724007

Sabadell, 08208, Spain

Location

Investigational Site Number 792005

Ankara, 06620, Turkey (Türkiye)

Location

Investigational Site Number 792006

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number 792001

Istanbul, 34111, Turkey (Türkiye)

Location

Investigational Site Number 792004

Istanbul, 34390, Turkey (Türkiye)

Location

Investigational Site Number 792003

Istanbul, 34844, Turkey (Türkiye)

Location

Investigational Site Number 792002

Izmir, 35100, Turkey (Türkiye)

Location

Investigational Site Number 826002

Cambridge, CB23 3RE, United Kingdom

Location

Investigational Site Number 826003

Exeter, EX2 5DW, United Kingdom

Location

Investigational Site Number 826004

Leicester, LE3 9QP, United Kingdom

Location

Investigational Site Number 826001

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: May 1, 2015
• Primary Completion: May 22, 2017
• Study Completion: August 14, 2017
• Last Updated: March 24, 2022
• Results First Posted: May 26, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); DE (5); CO (3); CL (6); IL (5); CZ (4); AU (5); TU (6); PT (2); ES (7); CA (2); IT (6); DK (2); FR (9); GR (1); AR (6); ME (4); KR (6); US (18)