NCT01759511

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

November 15, 2012

Results QC Date

February 17, 2017

Last Update Submit

February 17, 2017

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IdiopathicPulmonaryFibrosisIPF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144

    Weeks 72 and 144

  • Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144

    Weeks 72 and 144

  • All-cause Mortality

    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

Study Arms (1)

Simtuzumab

EXPERIMENTAL

Participants will receive simtuzumab.

Drug: Simtuzumab

Interventions

SimtuzumabDRUG

200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)

Also known as: GS-6624
Simtuzumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arizona Pulmonary Specialists, Ltd.

Scottsdale, Arizona, 85012, United States

Location

University of California

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisFibrosis

Interventions

simtuzumab

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Trial Disclosures
Organization
Gilead Sciences
ClinicalTrialDisclosures@gilead.com

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

January 3, 2013

Study Start

October 18, 2012

Primary Completion

February 19, 2016

Study Completion

February 19, 2016

Last Updated

April 4, 2017

Results First Posted

April 4, 2017

Record last verified: 2017-02

Locations

US(6)