Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Terminated

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Simtuzumab placebo; Drug: Simtuzumab

• Registration Number: NCT01769196
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Study Start: 2013-01-31
• Primary Completion: 2016-02-23
• Study Completion: 2016-02-23
• Results First Submitted: 2017-02-22
• Results First Submitted QC: 2017-02-22
• Status Verified: 2017-04
• Results First Posted: 2017-04-13
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 544

Inclusion Criteria

• Male or female subjects from 45 to 85 years of age
• Definite IPF within 3 years prior to screening
• Be able to walk at least 50 meters

Key

Exclusion Criteria

• Significant diseases other than IPF

• Obstructive lung disease

• Aortic aneurysm greater than or equal to 3.5 cm in diameter

• Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.

  • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
  • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located

• Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simtuzumab Placebo	Simtuzumab placebo	Participants will receive simtuzumab placebo for up to 254 weeks.
Simtuzumab	Simtuzumab	Participants will receive simtuzumab for up to 254 weeks.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Up to 148 weeks	Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
PFS Among the Participants With sLOXL2 ≥ 50th Percentile	Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 75th Percentile	Up to 148 weeks

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 151 weeks	Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile	Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile	Up to 151 weeks
Relative Change From Baseline in FVC % Predicted	Weeks 54, 106, and 130	* FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.; * Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130; * The relative change was calculated as 100% \* ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations	Up to 148 weeks
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations	Up to 148 weeks
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death	Up to 148 weeks
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)	Weeks 58, 106, and 130	* Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.; * The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score	Week 58, 106, and 130	* The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.; * The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.

Trial Locations

Locations (174)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Pulmonary Specialists, Ltd.; 🇺🇸 Scottsdale, Arizona, United States

Saint Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

The University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

David Geffen School of Medicine at University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Sansum Clinic; 🇺🇸 Santa Barbara, California, United States

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