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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Biological: KB001-A
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KB001-A<br>KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose. | Biological: KB001-A<br> <br> |
| Placebo Comparator: Placebo Comparator<br>Placebo administered up to 5x intravenously | Drug: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. | 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. | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of KB001-A | Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments | 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CF, Cystic Fibrosis, Pseudomonas aeruginosa (Pa)