A Phase 2 interventional study of KB003 and Placebo Comparator in Rheumatoid Arthritis, sponsored by Humanigen, Inc.. Terminated at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Humanigen, Inc. · Phase 2, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 9 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Humanigen, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Biological: KB003
Biological: KB003
Biological: KB003
Other: Placebo Comparator
KB003 IV x5 doses
Also known as: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Placebo IV x5 doses
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)
Time frame: Weeks 14 & 30
This was a two-part study with a safety run-in. The primary objective of the main portion of the study was to evaluate the safety, PK, and efficacy of selected repeat-dose regimens of KB003 in subjects with active moderate to severe rheumatoid arthritis who had an inadequate treatment outcome from prior biologic therapy.
| Milestone | KB003 70mg | KB003 200 mg | KB003 600 mg | Placebo |
|---|---|---|---|---|
| Started | 0 | 0 | 7 | 2 |
| Completed | 0 | 0 | 5 | 2 |
| Not completed | 0 | 0 | 2 | 0 |
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)
| Participants | KB003 600 mg | Placebo |
|---|---|---|
| This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. | 7 | 2 |
Collected over Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KB003 70mg | — | — | — |
| KB003 200 mg | — | — | — |
| KB003 600 mg | — | 1/7 (14.3%) | 7/7 (100%) |
| Placebo | — | 0/2 (0%) | 2/2 (100%) |
| Event | KB003 70mg | KB003 200 mg | KB003 600 mg | Placebo |
|---|---|---|---|---|
| Abdominal Hernia ObstructiveGastrointestinal disorders | — | — | 1/7 | — |
| Event | KB003 70mg | KB003 200 mg | KB003 600 mg | Placebo |
|---|---|---|---|---|
| Infections and InfestationsInfections and infestations | — | — | 3/7 | 1/2 |
| Psychiatric DisordersPsychiatric disorders | — | — | 1/7 | 1/2 |
| Injury, Poisoning and Procedural ComplicationsInjury, poisoning and procedural complications | — | — | 0/7 | 1/2 |
| Gastrointestinal DisorderGastrointestinal disorders | — | — | 2/7 | 0/2 |
| Muscoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders | — | — | 2/7 | 0/2 |
| Nervous System DisordersNervous system disorders | — | — | 2/7 | 0/2 |
| Cardiac DisordersCardiac disorders | — | — | 1/7 | 0/2 |
| Vascular DisordersVascular disorders | — | — | 1/7 | 0/2 |
| Age, Categorical(participants) | KB003 70mg | KB003 200 mg | KB003 600 mg | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | — | — | 0 | 0 | 0 |
| Between 18 and 65 years | — | — | 5 | 2 | 7 |
| >=65 years | — | — | 2 | 0 | 2 |
| Gender(participants) | KB003 70mg | KB003 200 mg | KB003 600 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | — | — | 4 | 1 | 5 |
| Male | — | — | 3 | 1 | 4 |
| Region of Enrollment(participants) | KB003 70mg | KB003 200 mg | KB003 600 mg | Placebo | Total |
|---|---|---|---|---|---|
| United States | — | — | 7 | 2 | 9 |
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Humanigen, Inc.