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

NCT ID: NCT00125385

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Dose group

Group Type: EXPERIMENTAL

GC1008

Intervention Type: BIOLOGICAL

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.

Cohort 2

Dose Group

Group Type: EXPERIMENTAL

GC1008

Intervention Type: BIOLOGICAL

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.

Cohort 3

Dose Group

Group Type: EXPERIMENTAL

GC1008

Intervention Type: BIOLOGICAL

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.

Cohort 4

Dose Group

Group Type: EXPERIMENTAL

GC1008

Intervention Type: BIOLOGICAL

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.

Cohort 5

Dose Group

Group Type: EXPERIMENTAL

GC1008

Intervention Type: BIOLOGICAL

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.

Interventions

GC1008

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

GC1008

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

GC1008

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

GC1008

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

GC1008

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Denver, Colorado, United States

Chicago, Illinois, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Rochester, Minnesota, United States

Nashville, Tennessee, United States

Seattle, Washington, United States

Belgium, , Belgium

Countries

United States; Belgium

References

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.

Reference Type: DERIVED

PMID: 33463535 (View on PubMed)

Other Identifiers

GC100800103

Identifier Type: -

Identifier Source: org_study_id