Idiopathic Pulmonary FibrosisPhase 1NCT00125385
Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1 study testing GC1008 in people with Idiopathic Pulmonary Fibrosis, run by Genzyme, a Sanofi Company at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- GC1008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2005to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Chicago, Illinois, 60637
Study site
Denver, Colorado, 80206
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee, 37232
Study site
Rochester, Minnesota, 55905
Study site
Seattle, Washington, 98195
About this study
Official title: Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis
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
- Being tested
- GC1008
- Keywords
- IPF, Idiopathic, Pulmonary, Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
GC1008Biological
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.
GC1008Biological
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.
GC1008Biological
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.
GC1008Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose group Receives: Biological: GC1008 |
| Cohort 2 | Experimental | Dose Group Receives: Biological: GC1008 |
| Cohort 3 | Experimental | Dose Group Receives: Biological: GC1008 |
| Cohort 4 | Experimental | Dose Group Receives: Biological: GC1008 |
| Cohort 5 | Experimental | Dose Group Receives: Biological: GC1008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF
Measured: up to 3 years
Secondary outcomes (1)
To evaluate potential clinical outcomes and bioactivity of GC1008
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125385
- Sponsor's protocol ID
- GC100800103
- Status last verified
- Apr 2015
- First submitted
- 29 Jul 2005
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33463535
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00125385
- Acronym / sponsor ID
- GC100800103
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, Idiopathic, Pulmonary, Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: GC1008Dose group |
| Cohort 2 | Experimental | Biological: GC1008Dose Group |
| Cohort 3 | Experimental | Biological: GC1008Dose Group |
| Cohort 4 | Experimental | Biological: GC1008Dose Group |
| Cohort 5 | Experimental | Biological: GC1008Dose Group |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC10080.3 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. | Biological | Cohort 1 |
| GC10081.0 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. | Biological | Cohort 2 |
| GC10082.0 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. | Biological | Cohort 3 |
| GC10084.0 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. | Biological | Cohort 4 |
| GC10088.0 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. | Biological | Cohort 5 |
Primary outcome
To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF
Time frame: up to 3 years
1 secondary outcome
To evaluate potential clinical outcomes and bioactivity of GC1008
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Derived from this study: PubMed 33463535Shenderov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC1008 in people with Idiopathic Pulmonary Fibrosis, run by Genzyme, a Sanofi Company at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.