Moderate-to-Severe AsthmaPhase 2KB003-04NCT01603277

Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

A Phase 2 study testing Anti-GM-CSF Monoclonal Antibody 400mg in people with Moderate-to-Severe Asthma, run by Humanigen, Inc. at 70 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma. Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Moderate-to-Severe Asthma
What is being tested?: Anti-GM-CSF Monoclonal Antibody 400mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 70 sitesin 6 countries
Study dates: Jul 2012to Jan 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

A diagnosis of asthma established for at least 2 years
Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose

Who cannot join

Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
History of any cardiovascular, neurological, hepatic, or renal condition
History of smoking within the past 12 months

Trial locations and contacts

70 sites in 6 countries.

Country

City, postcode or hospital

70 sites in 6 countries

United States33 sites

Study site
Ann Arbor, Michigan, 48109
Study site
Arlington, Texas, 76012
Study site
Birmingham, Alabama, 35216
Study site
Centennial, Colorado, 80112
Study site
Charleston, South Carolina, 29407
Study site
Charleston, South Carolina, 29425
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Colorado Springs, Colorado, 80907
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Denver, Colorado, 80206
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Duluth, Georgia, 30096
Study site
Fullerton, California, 92835
Study site
Granada Hills, California, 91344
Study site
Greenville, South Carolina, 29615
Study site
Lawrenceville, Georgia, 30046
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Lexington, Kentucky, 40536
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Los Angeles, California, 90025
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Miami, Florida, 33136
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Miami, Florida, 33171
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Milwaukee, Wisconsin, 53226
Study site
Oklahoma City, Oklahoma, 73120
Study site
Oklahoma City, Oklahoma, 73131
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Rancho Mirage, California, 92270
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Reno, Nevada, 89502
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Sacramento, California, 95819
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San Jose, California, 95117
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Savannah, Georgia, 31405
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St Louis, Missouri, 63110
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Sugarland, Texas, 77479
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Summit, New Jersey, 07901
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Tampa, Florida, 33613
Study site
Warwick, Rhode Island, 02886
Study site
Waterbury, Connecticut, 06708
Study site
Winston-Salem, North Carolina, 27157
Study site
Winter Park, Florida, 32789

Other trials in United States

Poland10 sites

Study site
Biała Rawska, 96-230
Study site
Bialystok, Podlaskie Voivodeship, 15-010
Study site
Bydgoszcz, 85-079
Study site
Krakow, 31-033
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Krakow, 31-159
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Lodz, 90-153
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Lublin, 20-089
Study site
Mrozy, Silesian Voivodeship, 05-321
Study site
Piasta, 15-044
Study site
Wiłomin, Slaski, 05-200

Other trials in Poland

Ukraine9 sites

Study site
Dnipropetrovsk, 49074
Study site
Donetsk, 83099
Study site
Kharkiv, 61124
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Kyiv, 03680
Study site
Odesa, 65009
Study site
Simferopol, 95043
Study site
Vinnytsia, 21029
Study site
Yalta, 98600
Study site
Zaporizhzhya, 69035

Other trials in Ukraine

Australia8 sites

Study site
Bedford Park, South Australia, 5042
Study site
Box Hill, Victoria, 3128
Study site
Cairns, Queensland, 4870
Study site
Frankston, Victoria, 3199
Study site
Melbourne, Victoria, 3050
Study site
Nedlands, Western Australia, 6009
Study site
Woodville, South Australia, 5011
Study site
Woolonggabba, Queensland, 4102

Other trials in Australia

France5 sites

Study site
Marseille, 13015
Study site
Montpellier, 34295
Study site
Rennes, 35033
Study site
Strasbourg, 67091
Study site
Tours, 37044

Other trials in France

United Kingdom5 sites

Study site
Bradford, West Yorkshire, BD9 6RJ
Study site
Leeds, West Yorkshire, LS9 7TF
Study site
Northwood, Middlesex, HA6 2RN
Study site
Southampton, SO16 6YD
Study site
Wishaw, Lanarkshire, ML2 0DP

Other trials in United Kingdom

About this study

Official title: A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

Conditions: Moderate-to-Severe Asthma
Being tested: Anti-GM-CSF Monoclonal Antibody 400mg, Placebo
Keywords: Asthma, GM-CSF, Moderate-to-Severe Asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-GM-CSF Monoclonal Antibody 400mgBiological
Anti-GM-CSF Monoclonal Antibody 400mg
PlaceboOther
Normal Saline

Study groups in NCT01603277
Study group	Role	What they receive
Anti-GM-CSF Monoclonal Antibody 400mg	Experimental	Not described Receives: Biological: Anti-GM-CSF Monoclonal Antibody 400mg
Normal Saline	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Percent Predicted FEV1 at Week 24
Measured: Baseline to Week 24

Secondary outcomes (3)

To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
Measured: Week 24
To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
Measured: Week 24
To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jan 2014

First posted22 May 2012 (estimated)
Study startJul 2012
Primary completionJul 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Moderate-to-Severe AsthmaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01603277
Sponsor's protocol ID: KB003-04
Acronym: KB003-04
Status last verified: Jan 2015
First submitted: 16 May 2012
Last updated: 2 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.
PubMed 26739717

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
ClinicalTrials.gov ID: NCT01603277
Acronym / sponsor ID: KB003-04 / KB003-04
Conditions: Moderate-to-Severe Asthma
Keywords: Asthma, GM-CSF, Moderate-to-Severe Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Humanigen, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 22 May 2012 (estimated)
Results: Posted 2 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Anti-GM-CSF Monoclonal Antibody 400mg	Experimental	Biological: Anti-GM-CSF Monoclonal Antibody 400mg
Normal Saline	Placebo comparator	Other: Placebo

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

A diagnosis of asthma established for at least 2 years
Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose

Key exclusion criteria (5 listed)

Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
History of any cardiovascular, neurological, hepatic, or renal condition
History of smoking within the past 12 months

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
Anti-GM-CSF Monoclonal Antibody 400mgAnti-GM-CSF Monoclonal Antibody 400mg	Biological	Anti-GM-CSF Monoclonal Antibody 400mg
PlaceboNormal Saline	Other	Normal Saline

Primary outcome

Change in Percent Predicted FEV1 at Week 24
Time frame: Baseline to Week 24

3 secondary outcomes

To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
Time frame: Week 24
To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
Time frame: Week 24
To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments
Time frame: Week 24

Results and safety

Results posted to the registry on 2 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anti-GM-CSF Monoclonal Antibody 400mg	78	64
Normal Saline	82	64

Primary outcome: Change in Percent Predicted FEV1 at Week 24

Time frame: Baseline to Week 24. Mean (Standard Deviation). Unit: Percent

Measure	Anti-GM-CSF Monoclonal Antibody 400mg n = 78	Normal Saline n = 82
Value	3.631 (12.6174)	2.000 (8.5251)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anti-GM-CSF Monoclonal Antibody 400mg	5 of 78 (6.4%)	10 of 78 (12.8%)	Not reported
Normal Saline	2 of 82 (2.4%)	15 of 82 (18.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26739717Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.

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RecruitingPhase 1/2
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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.

70 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-GM-CSF Monoclonal Antibody 400mg in people with Moderate-to-Severe Asthma, run by Humanigen, Inc. at 70 sites in 6 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 5 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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Poland, Ukraine, Australia, France and 1 more country. 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?

Yes. Results are posted in the registry (first posted 2 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Percent Predicted FEV1 at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603277, which also lists 1 linked publication.

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 2 Feb 2015.