Psoriatic Arthritis
Conditions
Keywords
Psoriatic Arthritis, Brodalumab, AMG 827
Brief summary
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
Interventions
210 mg brodalumab administered via subcutaneous injection.
140 mg brodalumab administered via subcutaneous injection.
DRUGPlacebo
Placebo administered via subcutaneous injection until week 24.
Sponsors
Bausch Health Americas, 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
Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least 1 psoriatic skin lesion.
Exclusion criteria
• -Subject has known history of active tuberculosis. * Subject has a planned surgical intervention between baseline and the week 52 evaluation. * Subject has an active infection or history of infections. * Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled. * Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject. Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS) • Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | Baseline and 16 Weeks | ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success. |
Countries
Canada, France, Germany, Greece, Hungary, Latvia, Mexico, Poland, Russia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 210 mg Brodalumab Administered via subcutaneous injections.
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection. | 163 |
| 140 mg Brodalumab Administered via subcutaneous injection.
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection. | 160 |
| Placebo Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24. | 161 |
| Total | 484 |
Baseline characteristics
| Characteristic | Total | Placebo | 140 mg Brodalumab | 210 mg Brodalumab |
|---|---|---|---|---|
| Age, Continuous | 48 years | 49 years | 48 years | 45 years |
| Region of Enrollment Canada | 32 participants | 9 participants | 14 participants | 9 participants |
| Region of Enrollment France | 11 participants | 2 participants | 2 participants | 7 participants |
| Region of Enrollment Germany | 27 participants | 13 participants | 7 participants | 7 participants |
| Region of Enrollment Greece | 11 participants | 2 participants | 6 participants | 3 participants |
| Region of Enrollment Hungary | 20 participants | 8 participants | 9 participants | 3 participants |
| Region of Enrollment Latvia | 15 participants | 3 participants | 6 participants | 6 participants |
| Region of Enrollment Mexico | 13 participants | 4 participants | 5 participants | 4 participants |
| Region of Enrollment Poland | 177 participants | 58 participants | 57 participants | 62 participants |
| Region of Enrollment Russian Federation | 56 participants | 19 participants | 17 participants | 20 participants |
| Region of Enrollment United States | 122 participants | 43 participants | 37 participants | 42 participants |
| Sex: Female, Male Female | 249 Participants | 85 Participants | 80 Participants | 84 Participants |
| Sex: Female, Male Male | 235 Participants | 76 Participants | 80 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 91 / 163 | 85 / 160 | 83 / 161 |
| serious Total, serious adverse events | 5 / 163 | 3 / 160 | 5 / 161 |
Outcome results
Primary
ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.
Time frame: Baseline and 16 Weeks
Population: The Primary Analysis Set consists of all randomized subjects who had the opportunity to complete the week 16 visit prior to termination of the study.~The numbers in the outcome measure data table reflect the percentage of subjects achieving ACR20.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 210 mg Brodalumab | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | 41.8 Percentage of Participants |
| 140 mg Brodalumab | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | 48.9 Percentage of Participants |
| Placebo | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | 24.7 Percentage of Participants |