TerminatedNCT02759562Updated Aug 17, 2018Results posted

Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

A Phase 2 interventional study of Andecaliximab and Placebo in Cystic Fibrosis, sponsored by Gilead Sciences. Terminated at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Why this study was terminated

Discontinuation of development for this indication

Phase: Phase 2
Study type: Interventional
Enrollment: 6
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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 studied

Cystic Fibrosis

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In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 6 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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
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.

Key Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 6 participants (actual)

Study arms

Experimental
Andecaliximab 600 mg (Part 1)
Andecaliximab 600 mg weekly for 8 weeks
Drug: Andecaliximab
Placebo comparator
Placebo (Part 1)
Placebo weekly for 8 weeks
Drug: Placebo
Experimental
Andecaliximab 300 mg (Part 2)
Andecaliximab 300 mg weekly for 8 weeks
Drug: Andecaliximab
Experimental
Andecaliximab 150 mg (Part 2)
Andecaliximab 150 mg + placebo weekly for 8 weeks
Drug: Andecaliximab · Drug: Placebo
Placebo comparator
Placebo (Part 2)
Placebo weekly for 8 weeks
Drug: Placebo
Experimental
Open-Label Extension
(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks
Drug: Andecaliximab

Interventions

DrugAndecaliximab
Administered via subcutaneous injection
Also known as: GS-5745
DrugPlacebo
Administered via subcutaneous injection

What researchers measure

Primary outcomes

Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8

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

Posted Jul 5, 2018

Limitations and caveats

Gilead made a decision to discontinue the development of andecaliximab in cystic fibrosis. This decision was not due to any safety concerns. Because only 6 participants were enrolled, no inferential analyses were performed.

Participant flow

Participants were enrolled at study sites in Australia and Europe. The first participant was screened on 04 November 2016. The last study visit occurred on 21 July 2017. The study was terminated after 6 participants were enrolled in Part 1 of the study. Therefore, Part 2 was not initiated.

Double-Blind Treatment Period (8 Weeks)

Participant flow — Double-Blind Treatment Period (8 Weeks)
Milestone	Andecaliximab	Placebo
Started	3	3
Completed	3	3
Not completed	0	0

Open-Label Treatment Period

Participant flow — Open-Label Treatment Period
Milestone	Andecaliximab	Placebo
Started	2	2
Completed	0	0
Not completed	2	2
Withdrew: Withdrew consent	1	0
Withdrew: Study terminated by sponsor	1	2

Outcome measures

PrimaryAbsolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time frame:: Baseline; Week 8
Reported as:: Mean · percent

Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
percent	Andecaliximab	Placebo
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8	-2.10 ± 4.446	2.90 ± 3.461

SecondaryAbsolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time frame:: Baseline; Week 8
Reported as:: Mean · percent

Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
percent	Andecaliximab	Placebo
Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8	1.01 ± 4.534	-1.45 ± 1.655

SecondaryRelative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time frame:: Baseline; Week 8
Reported as:: Mean · percent change

Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
percent change	Andecaliximab	Placebo
Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8	-3.85 ± 9.009	4.41 ± 4.196

SecondaryRelative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time frame:: Baseline; Week 8
Reported as:: Mean · percent change

Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
percent change	Andecaliximab	Placebo
Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8	2.28 ± 9.323	-1.98 ± 1.749

Adverse events

Collected over Baseline up to the last dose date plus 30 days (maximum exposure: 140 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Andecaliximab (Double-Blind)	0/3 (0%)	0/3 (0%)	3/3 (100%)
Placebo (Double-Blind)	0/3 (0%)	0/3 (0%)	3/3 (100%)
Andecaliximab (Open-Label)	0/4 (0%)	0/4 (0%)	4/4 (100%)

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Andecaliximab (Double-Blind)	Placebo (Double-Blind)	Andecaliximab (Open-Label)
HaemoptysisRespiratory, thoracic and mediastinal disorders	1/3	0/3	2/4
Cystic fibrosisCongenital, familial and genetic disorders	1/3	0/3	0/4
DiarrhoeaGastrointestinal disorders	1/3	0/3	0/4
GastritisGastrointestinal disorders	0/3	1/3	0/4
Injection site bruisingGeneral disorders	0/3	1/3	0/4
Injection site erythemaGeneral disorders	1/3	0/3	0/4
Injection site haematomaGeneral disorders	0/3	1/3	0/4
Injection site painGeneral disorders	1/3	0/3	0/4
Injection site pruritusGeneral disorders	1/3	1/3	0/4
RhinitisInfections and infestations	0/3	1/3	0/4

Baseline characteristics

Safety Analysis Set: participants who took at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	Andecaliximab	Placebo	Total
Mean	46.0 ± 20.42	43.3 ± 10.02	44.7 ± 14.46

Sex: Female, Male
Sex: Female, Male(Participants)	Andecaliximab	Placebo	Total
Female	2	0	2
Male	1	3	4

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Andecaliximab	Placebo	Total
White	3	3	6

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Andecaliximab	Placebo	Total
Not Hispanic or Latino	3	3	6

Region of Enrollment
Region of Enrollment(Participants)	Andecaliximab	Placebo	Total
United Kingdom	1	1	2
Australia	1	0	1
France	0	1	1
Germany	0	1	1
Spain	1	0	1

Pre-bronchodilator Forced expiratory volume in 1 second (FEV1) % predicted
Pre-bronchodilator Forced expiratory volume in 1 second (FEV1) % predicted(percent)	Andecaliximab	Placebo	Total
Mean	49.7 ± 8.70	59.1 ± 19.26	54.4 ± 14.33

Post-bronchodilator FEV1 % predicted
Post-bronchodilator FEV1 % predicted(percent)	Andecaliximab	Placebo	Total
Mean	52.1 ± 5.90	64.6 ± 20.58	58.3 ± 15.17

Study locations

5 sites

New Lambton, New South Wales, Australia
Montpellier, France
Berlin, Germany
Barcelona, Spain
Liverpool, United Kingdom

References and documents

Study documents

Study protocol · Jan 14, 2016
Study protocol · May 25, 2016
Statistical analysis plan · Sep 5, 2017

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02759562
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: May 3, 2016
Start date: Nov 4, 2016
Primary completion: Jul 6, 2017
Completion: Jul 21, 2017
Results posted: Jul 5, 2018
Last update: Aug 17, 2018

Study contacts

Gilead Study Director

study director · Gilead Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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