Clinical trial NCT00125385: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: IPF
Idiopathic
Pulmonary
Fibrosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF
timeFrame: up to 3 years
Secondary outcomes:
measure: To evaluate potential clinical outcomes and bioactivity of GC1008
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Nashville
country: United States
state: Tennessee
city: Seattle
country: United States
state: Washington
city: Belgium
country: Belgium
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.