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

This study is currently recruiting participants.
Verified April 2014 by KaloBios Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01695343
First received: September 25, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Biological: KB001-A
Drug: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa

Resource links provided by NLM:


Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    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:
  • Safety and tolerability of KB001-A [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments


Estimated Enrollment: 180
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695343

Contacts
Contact: Josh Pelham jpelham@kalobios.com

  Show 64 Study Locations
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Study Chair: Nestor A. Molfino, MD., MSc KaloBios Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01695343     History of Changes
Other Study ID Numbers: KB001A-05
Study First Received: September 25, 2012
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by KaloBios Pharmaceuticals:
Cystic Fibrosis
Pseudomonas aeruginosa (Pa)
CF

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014