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Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GC1008
GC1008
GC1008
GC1008
GC1008
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, Idiopathic, Pulmonary, Fibrosis

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Willing and able to provide written informed consent prior to any study-related procedures. Patients should have an established diagnosis of IPF. Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values. Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation > 80% Exclusion Criteria: Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion. Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions; History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin. History of clinically significant respiratory diseases other than IPF. History of clinically significant cardiac, hepatic, or renal disease. History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening. Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening. Other pathology that might interfere with the assessment of the safety or efficacy of the test article. Other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Dose group

Dose Group

Dose Group

Dose Group

Dose Group

Outcomes

Primary Outcome Measures

To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF

Secondary Outcome Measures

To evaluate potential clinical outcomes and bioactivity of GC1008

Full Information

First Posted
July 29, 2005
Last Updated
April 9, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00125385
Brief Title
Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
IPF, Idiopathic, Pulmonary, Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Dose group
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Dose Group
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Dose Group
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Dose Group
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Dose Group
Intervention Type
Biological
Intervention Name(s)
GC1008
Intervention Description
0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Intervention Type
Biological
Intervention Name(s)
GC1008
Intervention Description
1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Intervention Type
Biological
Intervention Name(s)
GC1008
Intervention Description
2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Intervention Type
Biological
Intervention Name(s)
GC1008
Intervention Description
4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Intervention Type
Biological
Intervention Name(s)
GC1008
Intervention Description
8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Primary Outcome Measure Information:
Title
To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
To evaluate potential clinical outcomes and bioactivity of GC1008
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide written informed consent prior to any study-related procedures. Patients should have an established diagnosis of IPF. Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values. Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation > 80% Exclusion Criteria: Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion. Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions; History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin. History of clinically significant respiratory diseases other than IPF. History of clinically significant cardiac, hepatic, or renal disease. History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening. Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening. Other pathology that might interfere with the assessment of the safety or efficacy of the test article. Other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
City
Belgium
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
33463535
Citation
Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2):e143226. doi: 10.1172/JCI143226.
Results Reference
derived

Learn more about this trial

Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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