NCT02759562

Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

Terminated Phase 2 Results posted Last updated 17 August 2018

What this trial tests

Phase 2 trial testing Andecaliximab in Cystic Fibrosis in 6 participants. Terminated before completion.

Timeline

4 November 2016

Primary endpoint
6 July 2017

21 July 2017

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	4 November 2016
Primary completion	6 July 2017
Estimated completion	21 July 2017
Sites	5 locations across France, United Kingdom, Germany, Australia, Spain

Drugs / interventions tested

• Andecaliximab — full drug profile →
• Placebo

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 Primary · Baseline; Week 8

Group	Value	95% CI
Andecaliximab	-2.10	± 4.446
Placebo	2.90	± 3.461

Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 Secondary · Baseline; Week 8

Group	Value	95% CI
Andecaliximab	1.01	± 4.534
Placebo	-1.45	± 1.655

Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 Secondary · Baseline; Week 8

Group	Value	95% CI
Andecaliximab	-3.85	± 9.009
Placebo	4.41	± 4.196

Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 Secondary · Baseline; Week 8

Group	Value	95% CI
Andecaliximab	2.28	± 9.323
Placebo	-1.98	± 1.749

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to the last dose date plus 30 days (maximum exposure: 140 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Andecaliximab (Double-Blind)

Serious: 0/3 (0%)

Deaths: 0/3

Placebo (Double-Blind)

Serious: 0/3 (0%)

Deaths: 0/3

Andecaliximab (Open-Label)

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (19 terms — click to expand)

Reaction	System	Andecaliximab (Double-Blind)	Placebo (Double-Blind)	Andecaliximab (Open-Label)
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—
Cystic fibrosis	Congenital, familial and genetic disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Injection site bruising	General disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Injection site haematoma	General disorders	—	—	—
Injection site pain	General disorders	—	—	—
Injection site pruritus	General disorders	—	—	—
Injection site rash	General disorders	—	—	—
Oral herpes	Infections and infestations	—	—	—
Rhinitis	Infections and infestations	—	—	—
Bacterial test positive	Investigations	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—
Seizure	Nervous system disorders	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT02759562 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunomodulatory roles of metalloproteinases in rheumatoid arthritis.
   Bian Y, Xiang Z, Wang Y, Ren Q, et al · · 2023 · cited 45× · PMID 38035026 · DOI 10.3389/fphar.2023.1285455
2. Monoclonal antibodies against metzincin targets.
   Santamaria S, de Groot R. · · 2019 · cited 35× · PMID 29488211 · DOI 10.1111/bph.14186
3. Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis.
   Skilton M, Krishan A, Patel S, Sinha IP, et al · · 2019 · cited 18× · PMID 30616300 · DOI 10.1002/14651858.cd009841.pub3
4. Exploring Proteases as Alternative Molecular Targets to Tackle Inflammation in Cystic Fibrosis Respiratory Infections.
   Sandri A, Boschi F. · · 2025 · cited 1× · PMID 40076497 · DOI 10.3390/ijms26051871
5. The COPD Pipeline XXXII.
   Gross N. · · 2016 · cited 1× · PMID 28848893 · DOI 10.15326/jcopdf.3.3.2016.0150