Cystic FibrosisPhase 2KB001-ANCT01695343
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
A Phase 2 study testing KB001-A in people with Cystic Fibrosis, run by Humanigen, Inc. at 67 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- KB001-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 67 sitesin 4 countries
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
67 sites in 4 countries.
67 sites in 4 countries
United States58 sites
Study site
Albany, New York, 12208
Study site
Albuquerque, New Mexico, 87131
Study site
Atlanta, Georgia, 30322
Study site
Aurora, Colorado, 80045
Study site
Austin, Texas, 78723
Study site
Boise, Idaho, 83712
Study site
Boston, Massachusetts, 02115
Study site
Charleston, South Carolina, 29425
Study site
Cincinnati, Ohio, 45229
Study site
Cincinnati, Ohio, 45267
Study site
Cleveland, Ohio, 44106
Study site
Colchester, Vermont, 05446
Study site
Columbus, Ohio, 43205
Study site
Dallas, Texas, 75390
Study site
Dayton, Ohio, 45404
Study site
Detriot, Michigan, 48201
Study site
Gainesville, Florida, 32610
Study site
Glenview, Illinois, 60025
Study site
Grand Rapids, Michigan, 49503
Study site
Hanover, New Hampshire, 03756
Study site
Hawthorne, New York, 10532
Study site
Hershey, Pennsylvania, 17033
Study site
Indianapolis, Indiana, 46202
Study site
Iowa City, Iowa, 52242
Study site
Kansas City, Missouri, 64108
Study site
Knoxville, Tennessee, 37916
Study site
Lexington, Kentucky, 40536
Study site
Little Rock, Arkansas, 72205
Study site
Long Beach, California, 90806
Study site
Louisville, Kentucky, 40202
Study site
Madison, Wisconsin, 53792
Study site
Manchester, New Hampshire, 03756
Study site
Memphis, Tennessee, 38105
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53226
Study site
Minneapolis, Minnesota, 55455
Study site
Mobile, Alabama, 36608
Study site
Nashville, Tennessee, 37232
Study site
New Hyde Park, New York, 11040
Study site
New York, New York, 10032
Study site
Oakland, California, 94611
Study site
Oklahoma City, Oklahoma, 73104
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32806
Study site
Philadelphia, Pennsylvania, 19102
Study site
Philadelphia, Pennsylvania, 19104
Study site
Phoenix, Arizona, 85016
Study site
Pittsburgh, Pennsylvania, 15224
Study site
Portland, Maine, 04102
Study site
Richmond, Virginia, 23219
Study site
San Antonio, Texas, 78212
Study site
St Louis, Missouri, 63104
Study site
St Louis, Missouri, 63110
Study site
Stanford, California, 94304
Study site
Tampa, Florida, 33606
Study site
Toledo, Ohio, 43606
Study site
Tucson, Arizona, 85724
Study site
Worchester, Massachusetts, 10655
Israel4 sites
Study site
Haifa, 31096
Study site
Jerusalem, 91240
Study site
Petah Tikva, 49202
Study site
Tel HaShomer, 52621
Australia3 sites
Study site
Nedlands, Western Australia, 6009
Study site
New Lambton, New South Wales, 2305
Study site
Parkville, Victoria, 3052
About this study
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
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
- Being tested
- KB001-A, Placebo Comparator
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa (Pa), CF
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB001-ABiological
Placebo ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: KB001-A |
| Placebo Comparator | Placebo comparator | Placebo administered up to 5x intravenously Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 Weeks
Secondary outcomes (1)
Safety and tolerability of KB001-A
Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanigen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nestor A. Molfino, MD., MSc, Study chair, KaloBios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695343
- Sponsor's protocol ID
- KB001A-05
- Acronym
- KB001-A
- Status last verified
- Jan 2015
- First submitted
- 25 Sep 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01695343
- Acronym / sponsor ID
- KB001-A / KB001A-05
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa (Pa), CF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Humanigen, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KB001-A | Experimental | Biological: KB001-AKB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose. |
| Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorPlacebo administered up to 5x intravenously |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB001-A | Biological | KB001-A |
| Placebo Comparator | Drug | Placebo Comparator |
Primary outcome
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
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.
1 secondary outcome
Safety and tolerability of KB001-A
Time frame: 16 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestor A. Molfino, MD., MSc study chair
KaloBios Pharmaceuticals, Inc.
67 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KB001-A in people with Cystic Fibrosis, run by Humanigen, Inc. at 67 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Israel, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.