Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Andecaliximab; Placebo
Intervention description: Administered via subcutaneous injection; Administered via subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.