Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

NCT02759562 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-404-18082015-002192-23
• Study Type: interventional
• Target: 6
• Locations: 5 countries
• Sites: 5

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

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

  Baseline; Week 8

Secondary Outcomes (3)

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

  Baseline; Week 8

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

  Baseline; Week 8

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

  Baseline; Week 8

Study Arms (6)

Andecaliximab 600 mg (Part 1)

EXPERIMENTAL

Andecaliximab 600 mg weekly for 8 weeks

Drug: Andecaliximab

Placebo (Part 1)

PLACEBO COMPARATOR

Placebo weekly for 8 weeks

Drug: Placebo

Andecaliximab 300 mg (Part 2)

EXPERIMENTAL

Andecaliximab 300 mg weekly for 8 weeks

Drug: Andecaliximab

Andecaliximab 150 mg (Part 2)

EXPERIMENTAL

Andecaliximab 150 mg + placebo weekly for 8 weeks

Drug: Andecaliximab; Drug: Placebo

Placebo (Part 2)

PLACEBO COMPARATOR

Placebo weekly for 8 weeks

Drug: Placebo

Open-Label Extension

EXPERIMENTAL

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

Drug: Andecaliximab

Interventions

Andecaliximab DRUG

Administered via subcutaneous injection

Also known as: GS-5745

Andecaliximab 150 mg (Part 2); Andecaliximab 300 mg (Part 2); Andecaliximab 600 mg (Part 1); Open-Label Extension

Placebo DRUG

Administered via subcutaneous injection

Andecaliximab 150 mg (Part 2); Placebo (Part 1); Placebo (Part 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (5)

Unknown Facility

New Lambton, New South Wales, Australia

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

andecaliximab

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Limitations and Caveats

Gilead made a decision to discontinue the development of andecaliximab in cystic fibrosis. This decision was not due to any safety concerns. Because only 6 participants were enrolled, no inferential analyses were performed.

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: November 4, 2016
• Primary Completion: July 6, 2017
• Study Completion: July 21, 2017
• Last Updated: August 17, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-07

Locations

DE (1); FR (1); GB (1); AU (1); ES (1)