Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Biologics-Inadequate, KB003, GM-CSF
Brief 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.
Interventions
BIOLOGICALKB003
KB003 IV x5 doses
OTHERPlacebo Comparator
Placebo IV x5 doses
Sponsors
Humanigen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Unstable medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| KB003 70mg Dose group not evaluated in this portion of study | 0 |
| KB003 200 mg Dose group not evaluated in this portion of study | 0 |
| KB003 600 mg 600 mg, KB003 a monoclonal antibody | 7 |
| Placebo Placebo comparator | 2 |
| Total | 9 |
Baseline characteristics
| Characteristic | KB003 600 mg | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 2 participants | 0 participants | 2 participants |
| Age, Categorical Between 18 and 65 years | 5 participants | 2 participants | 7 participants |
| Gender Female | 4 participants | 1 participants | 5 participants |
| Gender Male | 3 participants | 1 participants | 4 participants |
| Region of Enrollment United States | 7 participants | 2 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 7 / 7 | 2 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 1 / 7 | 0 / 2 |
Outcome results
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)
Time frame: Weeks 14 & 30
Population: This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KB003 600 mg | This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. | 7 Participants |
| Placebo | This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. | 2 Participants |