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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01695343
• Date of registration: 25/09/2012
• Prospective Registration: Yes
• Primary sponsor: KaloBios Pharmaceuticals
• Public title: Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment KB001-A
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa
• Date of first enrolment: December 2012
• Target sample size: 182
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01695343
• 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
• Phase: Phase 2

Countries of recruitment

Australia, Israel, New Zealand, United States

Contacts

• Name: Nestor A. Molfino, MD., MSc
• Affiliation: KaloBios Pharmaceuticals, Inc.

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Placebo Comparator

Biological: KB001-A

Primary Outcome(s)

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]

Secondary Outcome(s)

Safety and tolerability of KB001-A [Time Frame: 16 Weeks]

Secondary ID(s)

KB001A-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors