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

Humanigen

Status and phase

Completed

Phase 2

Conditions

Cystic Fibrosis

Treatments

Biological: KB001-A

Drug: Placebo Comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01695343

KB001A-05

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

12 to 50 years old

Volunteers

No Healthy Volunteers

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