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Program refocus
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KB003 70 mg | Experimental |
| |
| KB003 200 mg | Experimental |
| |
| KB003 600 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB003 | Biological | KB003 IV x5 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Weeks 14 & 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestor A. Molfino, MD, MSC | Humanigen, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | California | 94304 | United States | |||
The safety run-in portion was conducted in a small cohort of 7 active and 2 placebo subjects to evaluate the acceptability of repeat-dose safety. KB003 was administered by intravenous (IV) infusion as a 600 mg dose at wks 0, 2, 4, 8, and 12, with primary safety being evaluated at wk 14 and a follow-up (end of study) safety assessment at wk 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | KB003 70mg | Dose group not evaluated in this portion of study |
| FG001 | KB003 200 mg | Dose group not evaluated in this portion of study |
| FG002 | KB003 600 mg | 600 mg, KB003 a monoclonal antibody |
| FG003 | Placebo | Placebo comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KB003 70mg | Dose group not evaluated in this portion of study |
| BG001 | KB003 200 mg | Dose group not evaluated in this portion of study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects. | Posted | Number | Participants | Weeks 14 & 30 |
|
Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KB003 70mg | Dose group not evaluated in this portion of study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Hernia Obstructive | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
The study was terminated upon completion of safety run-in due to program refocus.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nestor A. Molfino, MD., MSc | KaloBios Pharmaceuticals, Inc. | 650-243-3103 | nmolfino@kalobios.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000710968 | lenzilumab |
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| Placebo Comparator | Other | Placebo IV x5 doses |
|
| Westlake Village |
| California |
| 91361 |
| United States |
| Miami | Florida | 33143 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Frederick | Maryland | 21702 | United States |
| Wheaton | Maryland | 20902 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63141 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Tulsa | Oklahoma | 74135 | United States |
| Oak Creek | Wisconsin | 53154 | United States |
| BG002 | KB003 600 mg | 600 mg, KB003 a monoclonal antibody |
| BG003 | Placebo | Placebo comparator |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Placebo comparator |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | KB003 200 mg | Dose group not evaluated in this portion of study | 0 | 0 | 0 | 0 |
| EG002 | KB003 600 mg | 600 mg, KB003 a monoclonal antibody | 1 | 7 | 7 | 7 |
| EG003 | Placebo | Placebo comparator | 0 | 2 | 2 | 2 |
| Infections and Infestations | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Muscoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
The sponsor has right of first publication of trial results, which will be a joint, multi-center publication of the study results from all appropriate sites contributing data, analysis and comments.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |