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Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02759562
Recruitment Status : Terminated (Discontinuation of development for this indication)
First Posted : May 3, 2016
Results First Posted : July 4, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Andecaliximab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis
Actual Study Start Date : November 4, 2016
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Andecaliximab 600 mg (Part 1)
Andecaliximab 600 mg weekly for 8 weeks
Drug: Andecaliximab
Administered via subcutaneous injection
Other Name: GS-5745

Placebo Comparator: Placebo (Part 1)
Placebo weekly for 8 weeks
Drug: Placebo
Administered via subcutaneous injection

Experimental: Andecaliximab 300 mg (Part 2)
Andecaliximab 300 mg weekly for 8 weeks
Drug: Andecaliximab
Administered via subcutaneous injection
Other Name: GS-5745

Experimental: Andecaliximab 150 mg (Part 2)
Andecaliximab 150 mg + placebo weekly for 8 weeks
Drug: Andecaliximab
Administered via subcutaneous injection
Other Name: GS-5745

Drug: Placebo
Administered via subcutaneous injection

Placebo Comparator: Placebo (Part 2)
Placebo weekly for 8 weeks
Drug: Placebo
Administered via subcutaneous injection

Experimental: Open-Label Extension
(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks
Drug: Andecaliximab
Administered via subcutaneous injection
Other Name: GS-5745




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

Secondary Outcome Measures :
  1. Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 [ Time Frame: Baseline; Week 8 ]
  2. Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 [ Time Frame: Baseline; Week 8 ]
  3. Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8 [ Time Frame: Baseline; Week 8 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759562


Locations
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Australia, New South Wales
New Lambton, New South Wales, Australia
France
Montpellier, France
Germany
Berlin, Germany
Spain
Barcelona, Spain
United Kingdom
Liverpool, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] January 14, 2016
Study Protocol: Amendment 2  [PDF] May 25, 2016
Statistical Analysis Plan  [PDF] September 5, 2017


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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02759562     History of Changes
Other Study ID Numbers: GS-US-404-1808
2015-002192-23 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Results First Posted: July 4, 2018
Last Update Posted: August 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs