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

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: Placebo Comparator; Biological: KB001-A

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton, New South Wales, Australia, 2305
  • Victoria
    • Parkville, Victoria, Australia, 3052
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
• Israel
  • Haifa, Israel, 31096
  • Jerusalem, Israel, 91240
  • Petah-Tikva, Israel, 49202
  • Tel Hashomer, Israel, 52621
• New Zealand
  • Dunedin, New Zealand, 9016
  • Hamilton, New Zealand, 3420
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Phoenix, Arizona, United States, 85016
    • Tucson, Arizona, United States, 85724
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • California
    • Long Beach, California, United States, 90806
    • Oakland, California, United States, 94611
    • Orange, California, United States, 92868
    • Stanford, California, United States, 94304
  • Colorado
    • Aurora, Colorado, United States, 80045
  • Florida
    • Gainesville, Florida, United States, 32610
    • Miami, Florida, United States, 33136
    • Orlando, Florida, United States, 32806
    • Tampa, Florida, United States, 33606
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Idaho
    • Boise, Idaho, United States, 83712
  • Illinois
    • Glenview, Illinois, United States, 60025
  • Indiana
    • Indianapolis, Indiana, United States, 46202
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kentucky
    • Lexington, Kentucky, United States, 40536
    • Louisville, Kentucky, United States, 40202
  • Maine
    • Portland, Maine, United States, 04102
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
    • Worchester, Massachusetts, United States, 10655
  • Michigan
    • Detriot, Michigan, United States, 48201
    • Grand Rapids, Michigan, United States, 49503
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
  • Missouri
    • Kansas City, Missouri, United States, 64108
    • St. Louis, Missouri, United States, 63104
    • St. Louis, Missouri, United States, 63110
  • New Hampshire
    • Hanover, New Hampshire, United States, 03756
    • Manchester, New Hampshire, United States, 03756
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
  • New York
    • Albany, New York, United States, 12208
    • Hawthorne, New York, United States, 10532
    • New Hyde Park, New York, United States, 11040
    • New York, New York, United States, 10032
  • Ohio
    • Cincinnati, Ohio, United States, 45229
    • Cincinnati, Ohio, United States, 45267
    • Cleveland, Ohio, United States, 44106
    • Columbus, Ohio, United States, 43205
    • Dayton, Ohio, United States, 45404
    • Toledo, Ohio, United States, 43606
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
    • Philadelphia, Pennsylvania, United States, 19104
    • Philadelphia, Pennsylvania, United States, 19102
    • Pittsburgh, Pennsylvania, United States, 15224
  • South Carolina
    • Charleston, South Carolina, United States, 29425
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
    • Memphis, Tennessee, United States, 38105
    • Nashville, Tennessee, United States, 37232
  • Texas
    • Austin, Texas, United States, 78723
    • Dallas, Texas, United States, 75390
    • San Antonio, Texas, United States, 78212
  • Vermont
    • Colchester, Vermont, United States, 05446
  • Virginia
    • Richmond, Virginia, United States, 23219
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
    • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KB001-A; 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
Placebo Comparator: Placebo Comparator; Placebo administered up to 5x intravenously	Drug: Placebo Comparator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Humanigen, Inc.
• Investigators: Study Chair: Nestor A. Molfino, MD., MSc, KaloBios Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; CF; Pseudomonas aeruginosa (Pa)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: KB001A-05