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

Cystic Fibrosis Clinical Trial

— KB001-A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695343
• Other study ID #: KB001A-05
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2012
• Last updated: January 12, 2015
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: KaloBios Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Biological:
• KB001-A

Drug:
• Placebo Comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KaloBios Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Israel,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and tolerability of KB001-A	Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments	16 Weeks	Yes