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

NCT01695343 | Completed Phase 2 DMC

• 1 other identifier: KB001A-05
• Study Type: interventional
• Target: 182
• Locations: 4 countries
• Sites: 67

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Pseudomonas aeruginosa (Pa); CF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and tolerability of KB001-A

  16 Weeks

Study Arms (2)

KB001-A

EXPERIMENTAL

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

Interventions

KB001-A BIOLOGICAL

KB001-A

Placebo Comparator DRUG

Placebo Comparator

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanigen, Inc.: lead

Study Sites (67)

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85016, United States

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Tucson, Arizona, 85724, United States

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Little Rock, Arkansas, 72205, United States

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Long Beach, California, 90806, United States

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Oakland, California, 94611, United States

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Orange, California, 92868, United States

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Stanford, California, 94304, United States

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Aurora, Colorado, 80045, United States

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Gainesville, Florida, 32610, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30322, United States

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Boise, Idaho, 83712, United States

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Glenview, Illinois, 60025, United States

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Indianapolis, Indiana, 46202, United States

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Iowa City, Iowa, 52242, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Portland, Maine, 04102, United States

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Boston, Massachusetts, 02115, United States

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Worchester, Massachusetts, 10655, United States

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Detriot, Michigan, 48201, United States

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Grand Rapids, Michigan, 49503, United States

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Minneapolis, Minnesota, 55455, United States

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Kansas City, Missouri, 64108, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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Hanover, New Hampshire, 03756, United States

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Manchester, New Hampshire, 03756, United States

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Albuquerque, New Mexico, 87131, United States

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Albany, New York, 12208, United States

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Hawthorne, New York, 10532, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10032, United States

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Cincinnati, Ohio, 45229, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43205, United States

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Dayton, Ohio, 45404, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73104, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19102, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15224, United States

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Charleston, South Carolina, 29425, United States

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Knoxville, Tennessee, 37916, United States

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Memphis, Tennessee, 38105, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78723, United States

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Dallas, Texas, 75390, United States

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San Antonio, Texas, 78212, United States

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Colchester, Vermont, 05446, United States

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Richmond, Virginia, 23219, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53226, United States

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New Lambton, New South Wales, 2305, Australia

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Parkville, Victoria, 3052, Australia

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Nedlands, Western Australia, 6009, Australia

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Haifa, 31096, Israel

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Jerusalem, 91240, Israel

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Petah Tikva, 49202, Israel

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Tel Litwinsky, 52621, Israel

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Dunedin, 9016, New Zealand

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Hamilton, 3420, New Zealand

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MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Nestor A. Molfino, MD., MSc

  KaloBios Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

AU (3); IL (4); NZ (2); US (58)