Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis
NCT ID: NCT02759562
Last Updated: 2018-08-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2016-11-04
2017-07-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Andecaliximab 600 mg (Part 1)
Andecaliximab 600 mg weekly for 8 weeks
Andecaliximab
Administered via subcutaneous injection
Placebo (Part 1)
Placebo weekly for 8 weeks
Placebo
Administered via subcutaneous injection
Andecaliximab 300 mg (Part 2)
Andecaliximab 300 mg weekly for 8 weeks
Andecaliximab
Administered via subcutaneous injection
Andecaliximab 150 mg (Part 2)
Andecaliximab 150 mg + placebo weekly for 8 weeks
Andecaliximab
Administered via subcutaneous injection
Placebo
Administered via subcutaneous injection
Placebo (Part 2)
Placebo weekly for 8 weeks
Placebo
Administered via subcutaneous injection
Open-Label Extension
(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks
Andecaliximab
Administered via subcutaneous injection
Interventions
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Andecaliximab
Administered via subcutaneous injection
Placebo
Administered via subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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New Lambton, New South Wales, Australia
Montpellier, , France
Berlin, , Germany
Barcelona, , Spain
Liverpool, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-002192-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-404-1808
Identifier Type: -
Identifier Source: org_study_id
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