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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02759562




Registration number
NCT02759562
Ethics application status
Date submitted
29/04/2016
Date registered
3/05/2016
Date last updated
17/08/2018

Titles & IDs
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
Secondary ID [1] 0 0
2015-002192-23
Secondary ID [2] 0 0
GS-US-404-1808
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Andecaliximab
Treatment: Drugs - Placebo

Experimental: Andecaliximab 600 mg (Part 1) - Andecaliximab 600 mg weekly for 8 weeks

Placebo Comparator: Placebo (Part 1) - Placebo weekly for 8 weeks

Experimental: Andecaliximab 300 mg (Part 2) - Andecaliximab 300 mg weekly for 8 weeks

Experimental: Andecaliximab 150 mg (Part 2) - Andecaliximab 150 mg + placebo weekly for 8 weeks

Placebo Comparator: Placebo (Part 2) - Placebo weekly for 8 weeks

Experimental: Open-Label Extension - (Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks


Treatment: Drugs: Andecaliximab
Administered via subcutaneous injection

Treatment: Drugs: Placebo
Administered via subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Timepoint [1] 0 0
Baseline; Week 8
Secondary outcome [1] 0 0
Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Timepoint [1] 0 0
Baseline; Week 8
Secondary outcome [2] 0 0
Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Timepoint [2] 0 0
Baseline; Week 8
Secondary outcome [3] 0 0
Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Timepoint [3] 0 0
Baseline; Week 8

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- New Lambton
Recruitment postcode(s) [1] 0 0
- New Lambton
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Montpellier
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Spain
State/province [3] 0 0
Barcelona
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02759562
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02759562