Idiopathic Pulmonary FibrosisPhase 1NCT01362231
A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing GS-6624 in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 7 sites in United States.
Trial summary
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- GS-6624
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2010to Dec 2012
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptable results on pulmonary function tests
- At rest oxygen saturation ≥90% on room air
- Adequate organ function
Who cannot join
- High resolution computer tomography pattern showing emphysema that is greater than fibrosis
- Acceptable results on whole body plethysmography
- History of clinically significant hepatic or renal disease
- Poorly controlled or severe diabetes mellitus
- Use of systemic immunosuppressants within 28 days of GS-6624 infusion
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Loess Hills Clinical Research Center
Council Bluffs, Iowa, 51503
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
UPMC Translational Research Center
Pittsburgh, Pennsylvania, 15213
Arizona Pulmonary Specialists
Scottsdale, Arizona, 85258
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.
Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.
Read the detailed description
The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011.
In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- GS-6624
- Keywords
- Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Fibrosis, Pulmonary Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-6624Drug
Also called AB0024
Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| GS-6624 125mg | Experimental | Not described Receives: Drug: GS-6624 |
| Experimental: GS-6624 200mg | Experimental | Not described Receives: Drug: GS-6624 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
Measured: 113 days
Secondary outcomes (1)
- To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ
Secondary Endpoints:
- Anti-GS-6624 antibody formation;
- Change in FVC and DLCO;
- Change in SGRQ score.
Measured: 113 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zung Thai, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362231
- Sponsor's protocol ID
- AB0024-201
- Status last verified
- Jul 2015
- First submitted
- 12 Apr 2011
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT01362231
- Acronym / sponsor ID
- AB0024-201
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 May 2011 (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.
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.
Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.
Detailed description
The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011.
In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS-6624 125mg | Experimental | Drug: GS-6624 |
| Experimental: GS-6624 200mg | Experimental | Drug: GS-6624 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acceptable results on pulmonary function tests
- At rest oxygen saturation ≥90% on room air
- Adequate organ function
Key exclusion criteria (5 listed)
- High resolution computer tomography pattern showing emphysema that is greater than fibrosis
- Acceptable results on whole body plethysmography
- History of clinically significant hepatic or renal disease
- Poorly controlled or severe diabetes mellitus
- Use of systemic immunosuppressants within 28 days of GS-6624 infusion
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 |
|---|---|---|
| GS-6624Also: AB0024Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period. | Drug | Experimental: GS-6624 200mg, GS-6624 125mg |
Primary outcome
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
Time frame: 113 days
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
1 secondary outcome
- To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ
Time frame: 113 Days
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 9 Jul 2015.
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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.
Zung Thai, MD study director
Gilead Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-6624 in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 7 sites in United States.
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 3 inclusion and 5 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 (time frame: 113 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2015.