Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Biological: KB001-A; Drug: Placebo Comparator

• Registration Number: NCT01695343
• Lead Sponsor: Humanigen, Inc.

Brief Summary

The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Study Start: 2012-12
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Individuals with CF who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms (CF exacerbation) in the 12 months before the Screening Visit
• Confirmed diagnosis of CF
• At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The most recent positive Pa culture must be within 12 weeks before the Screening Visit (or obtain a positive culture at screening)
• FEV1 % levels within acceptable ranges (per the study protocol)
• Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit

Exclusion Criteria

• Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit
• Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit
• Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0 Visit
• History of sputum cultures positive for B. cepacia complex in the 2 years before the Screening Visit
• History of organ transplantation
• Current smoker (tobacco, marijuana, or any other material). Use of smokeless inhalers/vaporizers for these materials is also prohibited
• History of drug addiction or alcohol abuse in the 12 months before the Screening Visit
• History of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction
• Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test
• Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0 Visit, whichever is longer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KB001-A	KB001-A	KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.
Placebo Comparator	Placebo Comparator	Placebo administered up to 5x intravenously

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms.	16 Weeks	Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of KB001-A	16 Weeks	Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments