Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

A Phase 2 study testing KB003 in people with Rheumatoid Arthritis, run by Humanigen, Inc. at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: KB003
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 11 sitesUnited States
Study dates: Jan 2010to Feb 2012
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 6 swollen and at least 6 tender joints
C-reactive Protein (CRP) > Upper Limit Normal (ULN)
Prior inadequate response from biologic therapy
Stable regimens of concomitant RA therapies

Who cannot join

Unstable medical conditions

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Study site
Frederick, Maryland, 21702
Study site
Honolulu, Hawaii, 96813
Study site
Miami, Florida, 33143
Study site
Oak Creek, Wisconsin, 53154
Study site
St Louis, Missouri, 63117
Study site
St Louis, Missouri, 63141
Study site
Stanford, California, 94304
Study site
Tulsa, Oklahoma, 74135
Study site
Westlake Village, California, 91361
Study site
Wheaton, Maryland, 20902
Study site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy

Conditions: Rheumatoid Arthritis
Being tested: KB003, Placebo Comparator
Keywords: Rheumatoid Arthritis, Biologics-Inadequate, KB003, GM-CSF
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

KB003Biological
Also called Recombinant anti-GM-CSF IgG1K monoclonal antibody
KB003 IV x5 doses
Placebo ComparatorOther
Placebo IV x5 doses

Study groups in NCT00995449
Study group	Role	What they receive
KB003 70 mg	Experimental	Not described Receives: Biological: KB003
KB003 200 mg	Experimental	Not described Receives: Biological: KB003
KB003 600 mg	Experimental	Not described Receives: Biological: KB003
Placebo	Placebo comparator	Not described Receives: Other: Placebo Comparator

What is being measured

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

This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)
Measured: Weeks 14 & 30

Timeline

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

Jan 2010Feb 2012

First posted15 Oct 2009 (estimated)
Study startJan 2010
Primary completionMar 2011
Study completionFeb 2012

Why it stopped: Program refocus

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.
Other trials for Rheumatoid ArthritisStudies 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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00995449
Sponsor's protocol ID: KB003-02
Status last verified: Jun 2014
First submitted: 5 Oct 2009
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy
ClinicalTrials.gov ID: NCT00995449
Acronym / sponsor ID: KB003-02
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Biologics-Inadequate, KB003, GM-CSF
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Program refocus
Enrolment: 9 participants (actual)
Lead sponsor: Humanigen, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Mar 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 15 Oct 2009 (estimated)
Results: Posted 25 Sep 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
KB003 70 mg	Experimental	Biological: KB003
KB003 200 mg	Experimental	Biological: KB003
KB003 600 mg	Experimental	Biological: KB003
Placebo	Placebo comparator	Other: Placebo Comparator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

At least 6 swollen and at least 6 tender joints
C-reactive Protein (CRP) > Upper Limit Normal (ULN)
Prior inadequate response from biologic therapy
Stable regimens of concomitant RA therapies

Key exclusion criteria (1 listed)

Unstable medical conditions

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
KB003Also: Recombinant anti-GM-CSF IgG1K monoclonal antibodyKB003 IV x5 doses	Biological	KB003 200 mg, KB003 600 mg, KB003 70 mg
Placebo ComparatorPlacebo IV x5 doses	Other	Placebo

Primary outcome

This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
Time frame: Weeks 14 & 30
KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)

Results and safety

Results posted to the registry on 25 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KB003 70mg	0	0
KB003 200 mg	0	0
KB003 600 mg	7	5
Placebo	2	2

Primary outcome: This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.

Time frame: Weeks 14 & 30. Number. Unit: Participants

Measure	KB003 600 mg n = 7	Placebo n = 2
Value	7	2

Population analysed: This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.

Adverse events

Time frame: Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KB003 70mg	0 of 0	0 of 0	Not reported
KB003 200 mg	0 of 0	0 of 0	Not reported
KB003 600 mg	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated upon completion of safety run-in due to program refocus.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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

Humanigen, Inc.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KB003 in people with Rheumatoid Arthritis, run by Humanigen, Inc. at 11 sites in United States.

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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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 25 Sep 2012). 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?

This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. (time frame: Weeks 14 & 30). 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 NCT00995449.

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 9 Jun 2014.