Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.

Official Title
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A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Simtuzumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Previous participation in Phase 1 Gilead clinical trial Diagnosis of idiopathic pulmonary fibrosis Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception Females must discontinue nursing Comply with study requirements Have adequate organ function Key Exclusion Criteria: History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study Pregnant or lactating Clinically significant heart, hepatic or renal disease History of cancer within 5 years of screening Infection that is not controlled despite antibiotics or other treatment History of bleeding diathesis within the last 6 months of Day 1 Known history of human immunodeficiency virus, hepatitis B or C Concern's for subjects compliance Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required Placed on a lung transplant list Previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab Note: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simtuzumab<br>Participants will receive simtuzumab. | Drug: Simtuzumab<br>* 200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)<br>* Other names: GS-6624;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety Profile of Simtuzumab | The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality. | 30 days post last study treatment (up to 165 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144 | FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath. Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144. | Weeks 72 and 144 | 
| Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144 | DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood. Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144. | Weeks 72 and 144 | 
| All-cause Mortality | All-cause mortality was assessed as a number of participants who died from any cause. | Up to 165 weeks | 
| Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120 |  | Weeks 72 and 120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic, Pulmonary, Fibrosis, IPF