Idiopathic Pulmonary FibrosisPhase 2ATLASNCT01759511
Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing Simtuzumab in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 6 sites in United States.
Trial summary
The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Simtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Oct 2012to 19 Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous participation in Phase 1 Gilead clinical trial
- Diagnosis of idiopathic pulmonary fibrosis
- Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
- Females must discontinue nursing
- Comply with study requirements
- Have adequate organ function
Who cannot join
- History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
- Pregnant or lactating
- Clinically significant heart, hepatic or renal disease
- History of cancer within 5 years of screening
- Infection that is not controlled despite antibiotics or other treatment
- History of bleeding diathesis within the last 6 months of Day 1
Show all 12Show fewer
- Known history of human immunodeficiency virus, hepatitis B or C
- Concern's for subjects compliance
- Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
- Placed on a lung transplant list
- Previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of California
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, 85012
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)
The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Simtuzumab
- Keywords
- Idiopathic, Pulmonary, Fibrosis, IPF
- 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.
SimtuzumabDrug
Also called GS-6624
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
| Study group | Role | What they receive |
|---|---|---|
| Simtuzumab | Experimental | Participants will receive simtuzumab. Receives: Drug: Simtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety Profile of Simtuzumab
The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
Measured: 30 days post last study treatment (up to 165 weeks)
Secondary outcomes (4)
Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144
- FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.
- Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144.
Measured: Weeks 72 and 144
Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144
- DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.
- Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144.
Measured: Weeks 72 and 144
All-cause Mortality
All-cause mortality was assessed as a number of participants who died from any cause.
Measured: Up to 165 weeks
Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120
Measured: Weeks 72 and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study start18 Oct 2012
- Primary completion19 Feb 2016
- Study completion19 Feb 2016
Why it stopped: The Study was terminated due to lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759511
- Sponsor's protocol ID
- GS-US-322-0206
- Acronym
- ATLAS
- Status last verified
- Feb 2017
- First submitted
- 15 Nov 2012
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT01759511
- Acronym / sponsor ID
- ATLAS / GS-US-322-0206
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic, Pulmonary, Fibrosis, IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Study was terminated due to lack of efficacy.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2012 (actual)
- Primary completion
- 19 Feb 2016 (actual)
- Study completion
- 19 Feb 2016 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simtuzumab | Experimental | Drug: SimtuzumabParticipants will receive simtuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previous participation in Phase 1 Gilead clinical trial
- Diagnosis of idiopathic pulmonary fibrosis
- Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
- Females must discontinue nursing
- Comply with study requirements
Key exclusion criteria (12 listed)
- History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
- Pregnant or lactating
- Clinically significant heart, hepatic or renal disease
- History of cancer within 5 years of screening
- Infection that is not controlled despite antibiotics or other treatment
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 |
|---|---|---|
| SimtuzumabAlso: GS-6624200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1) | Drug | Simtuzumab |
Primary outcome
Overall Safety Profile of Simtuzumab
Time frame: 30 days post last study treatment (up to 165 weeks)
The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
4 secondary outcomes
Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144
Time frame: Weeks 72 and 144
Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144
Time frame: Weeks 72 and 144
All-cause Mortality
Time frame: Up to 165 weeks
Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120
Time frame: Weeks 72 and 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gilead Study Director study director
Gilead Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simtuzumab in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 6 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Safety Profile of Simtuzumab (time frame: 30 days post last study treatment (up to 165 weeks)). 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 4 Apr 2017.