Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02759562
• Date of registration: 29/04/2016
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis
• Scientific title: A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis
• Date of first enrolment: November 4, 2016
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02759562
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Ireland, Spain, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: Andecaliximab

Primary Outcome(s)

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

Secondary Outcome(s)

Absolute Change in Post-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]

Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 [Time Frame: Baseline; Week 8]

Secondary ID(s)

GS-US-404-1808

2015-002192-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02759562