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Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Andecaliximab

Placebo

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Andecaliximab 600 mg (Part 1)

Placebo (Part 1)

Andecaliximab 300 mg (Part 2)

Andecaliximab 150 mg (Part 2)

Placebo (Part 2)

Open-Label Extension

Arm Description

Andecaliximab 600 mg weekly for 8 weeks

Placebo weekly for 8 weeks

Andecaliximab 300 mg weekly for 8 weeks

Andecaliximab 150 mg + placebo weekly for 8 weeks

Placebo weekly for 8 weeks

(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks

Outcomes

Primary Outcome Measures

Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Secondary Outcome Measures

Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Full Information

NCT ID

NCT02759562

First Posted

April 29, 2016

Last Updated

July 20, 2018

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02759562

Brief Title

Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

Official Title

A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Discontinuation of development for this indication

Study Start Date

November 4, 2016 (Actual)

Primary Completion Date

July 6, 2017 (Actual)

Study Completion Date

July 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Andecaliximab 600 mg (Part 1)

Arm Type

Experimental

Arm Description

Andecaliximab 600 mg weekly for 8 weeks

Arm Title

Placebo (Part 1)

Arm Type

Placebo Comparator

Arm Description

Placebo weekly for 8 weeks

Arm Title

Andecaliximab 300 mg (Part 2)

Arm Type

Experimental

Arm Description

Andecaliximab 300 mg weekly for 8 weeks

Arm Title

Andecaliximab 150 mg (Part 2)

Arm Type

Experimental

Arm Description

Andecaliximab 150 mg + placebo weekly for 8 weeks

Arm Title

Placebo (Part 2)

Arm Type

Placebo Comparator

Arm Description

Placebo weekly for 8 weeks

Arm Title

Open-Label Extension

Arm Type

Experimental

Arm Description

(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks

Intervention Type

Drug

Intervention Name(s)

Andecaliximab

Other Intervention Name(s)

GS-5745

Intervention Description

Administered via subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered via subcutaneous injection

Primary Outcome Measure Information:

Title

Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time Frame

Baseline; Week 8

Secondary Outcome Measure Information:

Title

Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time Frame

Baseline; Week 8

Title

Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time Frame

Baseline; Week 8

Title

Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8

Time Frame

Baseline; Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

City

New Lambton

State/Province

New South Wales

Country

Australia

City

Montpellier

Country

France

City

Berlin

Country

Germany

City

Barcelona

Country

Spain

City

Liverpool

Country

United Kingdom

12. IPD Sharing Statement

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Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

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