Cystic FibrosisPhase 2NCT02759562
Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis
A Phase 2 study testing Andecaliximab in people with Cystic Fibrosis, run by Gilead Sciences at 5 sites in 5 countries.
Trial summary
The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment. There will be 2 parts to this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Andecaliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 4 Nov 2016to 21 Jul 2017
- 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
- Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report criteria
- Must have a body weight of > 40 kg (88.2 lb) at study screening
- Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at screening
- Two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 criteria:
- The relative difference of FEV1(L), calculated as the absolute value of [(first FEV1 - second FEV1) / first FEV1] x 100 should be < 12% AND
- The absolute difference in FEV1 should be < 200 ml
Show all 9Show fewer
- Negative Sputum Investigation/History of any Mycobacterium spp. or Burkholderia spp. per specified protocol-defined time periods
- Clinically stable with no evidence of significant respiratory symptoms that would require administration of IV antibiotics, oxygen supplementation, or hospitalization within 30 days of baseline.
- On stable CF chronic medical regimen for at least 30 days prior to baseline and expected to remain stable through the completion of the study. This includes but is not limited to: chronic azithromycin use, inhaled bronchodilators, inhaled corticosteroids, inhaled dornase alpha, inhaled hypertonic saline, inhaled mannitol, ivacaftor, and/or ivacaftor/lumacaftor.
Who cannot join
- Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics within 30 days of baseline. Prophylactic and chronic doxycycline use is prohibited during the study.
- Hospitalization for a respiratory event within 30 days of baseline
- Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline
- Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this exclusion criterion if supplemental oxygen is used for comfort only)
- History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis
The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment.
There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.
- Conditions
- Cystic Fibrosis
- Being tested
- Andecaliximab, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndecaliximabDrug
Also called GS-5745
Administered via subcutaneous injection
PlaceboDrug
Administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Andecaliximab 600 mg (Part 1) | Experimental | Andecaliximab 600 mg weekly for 8 weeks Receives: Drug: Andecaliximab |
| Placebo (Part 1) | Placebo comparator | Placebo weekly for 8 weeks Receives: Drug: Placebo |
| Andecaliximab 300 mg (Part 2) | Experimental | Andecaliximab 300 mg weekly for 8 weeks Receives: Drug: Andecaliximab |
| Andecaliximab 150 mg (Part 2) | Experimental | Andecaliximab 150 mg + placebo weekly for 8 weeks Receives: Drug: Andecaliximab; Drug: Placebo |
| Placebo (Part 2) | Placebo comparator | Placebo weekly for 8 weeks Receives: Drug: Placebo |
| Open-Label Extension | Experimental | (Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks Receives: Drug: Andecaliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Measured: Baseline; Week 8
Secondary outcomes (3)
Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Measured: Baseline; Week 8
Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Measured: Baseline; Week 8
Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Measured: Baseline; Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start4 Nov 2016
- Primary completion6 Jul 2017
- Study completion21 Jul 2017
Why it stopped: Discontinuation of development for this indication
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 Cystic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 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
- NCT02759562
- Sponsor's protocol ID
- GS-US-404-1808
- Other IDs
- 2015-002192-23, 2015
- Status last verified
- Jul 2018
- First submitted
- 29 Apr 2016
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02759562
- Acronym / sponsor ID
- GS-US-404-1808
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of development for this indication
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Posted 5 Jul 2018
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 effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment.
There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Andecaliximab 600 mg (Part 1) | Experimental | Drug: AndecaliximabAndecaliximab 600 mg weekly for 8 weeks |
| Placebo (Part 1) | Placebo comparator | Drug: PlaceboPlacebo weekly for 8 weeks |
| Andecaliximab 300 mg (Part 2) | Experimental | Drug: AndecaliximabAndecaliximab 300 mg weekly for 8 weeks |
| Andecaliximab 150 mg (Part 2) | Experimental | Drug: Andecaliximab, Drug: PlaceboAndecaliximab 150 mg + placebo weekly for 8 weeks |
| Placebo (Part 2) | Placebo comparator | Drug: PlaceboPlacebo weekly for 8 weeks |
| Open-Label Extension | Experimental | Drug: Andecaliximab(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report criteria
- Must have a body weight of > 40 kg (88.2 lb) at study screening
- Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at screening
- Two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 criteria:
- Negative Sputum Investigation/History of any Mycobacterium spp. or Burkholderia spp. per specified protocol-defined time periods
Key exclusion criteria (6 listed)
- Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics within 30 days of baseline. Prophylactic and chronic doxycycline use is prohibited during the study.
- Hospitalization for a respiratory event within 30 days of baseline
- Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline
- Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this exclusion criterion if supplemental oxygen is used for comfort only)
- History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list
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 |
|---|---|---|
| AndecaliximabAlso: GS-5745Administered via subcutaneous injection | Drug | Andecaliximab 150 mg (Part 2), Andecaliximab 300 mg (Part 2), Andecaliximab 600 mg (Part 1), Open-Label Extension |
| PlaceboAdministered via subcutaneous injection | Drug | Andecaliximab 150 mg (Part 2), Placebo (Part 1), Placebo (Part 2) |
Primary outcome
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
3 secondary outcomes
Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Andecaliximab in people with Cystic Fibrosis, run by Gilead Sciences at 5 sites in 5 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 9 inclusion and 6 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, France, Germany, Spain, United Kingdom. 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. Some participants in this study may receive a placebo. 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 5 Jul 2018). 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?
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 (time frame: Baseline; Week 8). 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 17 Aug 2018.