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.
Detailed description
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 and week 24. 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
* Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the distal interphalangeal joints)). * Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated CRP.
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 |
|---|---|---|
| American College of Rheumatology (ACR) 20 Response | 16 weeks | An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI)75 | 16 Weeks | PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching. |
Countries
Belgium, Bulgaria, Canada, Czechia, Estonia, France, Greece, Hungary, Italy, Mexico, Poland, Russia, Slovakia, Spain, Switzerland, United Kingdom, 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 | 159 |
| 140 mg Brodalumab Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection | 158 |
| Placebo Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24. | 161 |
| Total | 478 |
Baseline characteristics
| Characteristic | Total | 210 mg Brodalumab | 140 mg Brodalumab | Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 15 Participants | 20 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 427 Participants | 144 Participants | 138 Participants | 145 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 12.28 | 49.1 years STANDARD_DEVIATION 12.24 | 49.9 years STANDARD_DEVIATION 12.8 | 48.1 years STANDARD_DEVIATION 11.79 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 2 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 459 Participants | 155 Participants | 152 Participants | 152 Participants |
| Region of Enrollment Belgium | 2 participants | 0 participants | 0 participants | 2 participants |
| Region of Enrollment Bulgaria | 9 participants | 2 participants | 4 participants | 3 participants |
| Region of Enrollment Canada | 9 participants | 4 participants | 3 participants | 2 participants |
| Region of Enrollment Czech Republic | 19 participants | 2 participants | 8 participants | 9 participants |
| Region of Enrollment Estonia | 9 participants | 4 participants | 3 participants | 2 participants |
| Region of Enrollment France | 8 participants | 4 participants | 2 participants | 2 participants |
| Region of Enrollment Greece | 6 participants | 2 participants | 2 participants | 2 participants |
| Region of Enrollment Hungary | 15 participants | 5 participants | 6 participants | 4 participants |
| Region of Enrollment Italy | 9 participants | 2 participants | 5 participants | 2 participants |
| Region of Enrollment Mexico | 12 participants | 5 participants | 3 participants | 4 participants |
| Region of Enrollment Poland | 139 participants | 50 participants | 45 participants | 44 participants |
| Region of Enrollment Russian Federation | 71 participants | 22 participants | 22 participants | 27 participants |
| Region of Enrollment Slovakia | 15 participants | 5 participants | 5 participants | 5 participants |
| Region of Enrollment Spain | 21 participants | 10 participants | 4 participants | 7 participants |
| Region of Enrollment Switzerland | 12 participants | 1 participants | 6 participants | 5 participants |
| Region of Enrollment United Kingdom | 15 participants | 6 participants | 3 participants | 6 participants |
| Region of Enrollment United States | 107 participants | 35 participants | 37 participants | 35 participants |
| Sex: Female, Male Female | 230 Participants | 70 Participants | 80 Participants | 80 Participants |
| Sex: Female, Male Male | 248 Participants | 89 Participants | 78 Participants | 81 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 | 84 / 158 | 79 / 158 | 71 / 159 |
| serious Total, serious adverse events | 10 / 158 | 5 / 158 | 4 / 159 |
Outcome results
Primary
American College of Rheumatology (ACR) 20 Response
An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 210 mg Brodalumab | American College of Rheumatology (ACR) 20 Response | 0 percentage of participants |
| 140 mg Brodalumab | American College of Rheumatology (ACR) 20 Response | 21.8 percentage of participants |
| Placebo | American College of Rheumatology (ACR) 20 Response | 36.5 percentage of participants |
Secondary
Psoriasis Area and Severity Index (PASI)75
PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.
Time frame: 16 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 210 mg Brodalumab | Psoriasis Area and Severity Index (PASI)75 | 70.3 percentage of participants |
| 140 mg Brodalumab | Psoriasis Area and Severity Index (PASI)75 | 55.6 percentage of participants |
| Placebo | Psoriasis Area and Severity Index (PASI)75 | 0 percentage of participants |