NCT00125385

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

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

July 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

July 29, 2005

Last Update Submit

April 9, 2015

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPFIdiopathicPulmonaryFibrosis

Outcome Measures

Primary Outcomes (1)

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

    up to 3 years

Secondary Outcomes (1)

  • To evaluate potential clinical outcomes and bioactivity of GC1008

    up to 3 years

Study Arms (5)

Cohort 1

EXPERIMENTAL

Dose group

Biological: GC1008

Cohort 2

EXPERIMENTAL

Dose Group

Biological: GC1008

Cohort 3

EXPERIMENTAL

Dose Group

Biological: GC1008

Cohort 4

EXPERIMENTAL

Dose Group

Biological: GC1008

Cohort 5

EXPERIMENTAL

Dose Group

Biological: GC1008

Interventions

GC1008BIOLOGICAL

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 1

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Denver, Colorado, 80206, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Seattle, Washington, 98195, United States

Location

Unknown Facility

Belgium, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 33463535DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisFibrosis

Interventions

fresolimumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

July 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

BE(1)US(7)