A Phase 3 interventional study of 210 mg brodalumab and 140 mg brodalumab in Psoriatic Arthritis, sponsored by Bausch Health Americas, Inc.. Terminated at 152 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Bausch Health Americas, Inc. · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 478 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administered via subcutaneous injections
Drug: 210 mg brodalumab
Administered via subcutaneous injection
Drug: 140 mg brodalumab
Administered via subcutaneous injection until week 24.
Drug: Placebo
210 mg brodalumab administered via subcutaneous injection
Also known as: AMG 827
140 mg brodalumab administered via subcutaneous injection
Also known as: AMG 827
Placebo administered via subcutaneous injection until week 24.
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
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
| Milestone | 210 mg Brodalumab | 140 mg Brodalumab | Placebo |
|---|---|---|---|
| Started | 159 | 158 | 161 |
| Completed | 158 | 158 | 159 |
| Not completed | 1 | 0 | 2 |
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).
| percentage of participants | 210 mg Brodalumab | 140 mg Brodalumab | Placebo |
|---|---|---|---|
| American College of Rheumatology (ACR) 20 Response | 0 (0 to 0) | 21.8 (10.6 to 33.1) | 36.5 (22.8 to 45.3) |
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.
| percentage of participants | 210 mg Brodalumab | 140 mg Brodalumab | Placebo |
|---|---|---|---|
| Psoriasis Area and Severity Index (PASI)75 | 70.3 (57.6 to 82.9) | 55.6 (27.9 to 56.6) | 0 (0 to 0) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 210 mg Brodalumab | — | 10/158 (6.3%) | 84/158 (53.2%) |
| 140 mg Brodalumab | — | 5/158 (3.2%) | 79/158 (50%) |
| Placebo | — | 4/159 (2.5%) | 71/159 (44.7%) |
| Event | 210 mg Brodalumab | 140 mg Brodalumab | Placebo |
|---|---|---|---|
| UrosepsisInfections and infestations | 1/158 | 0/158 | 0/159 |
| Squimos Cell Carcinoma of the VulvaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/158 | 0/158 | 0/159 |
| Major DepressionPsychiatric disorders | 1/158 | 0/158 | 0/159 |
| DizzinessGeneral disorders | 0/158 | 1/158 | 0/159 |
| Lens DislocationEye disorders | 1/158 | 0/158 | 0/159 |
| CholelithiasisHepatobiliary disorders | 0/158 | 1/158 | 0/159 |
| Drug reaction with Eosinaphilia and Systematic symptomsSkin and subcutaneous tissue disorders | 0/158 | 1/158 | 0/159 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/158 | 0/158 | 0/159 |
| Synovial CystMusculoskeletal and connective tissue disorders | 1/158 | 0/158 | 0/159 |
| Muscular WeaknessMusculoskeletal and connective tissue disorders | 0/158 | 1/158 | 0/159 |
| Event | 210 mg Brodalumab | 140 mg Brodalumab | Placebo |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 24/158 | 28/158 | 7/159 |
| HypertensionVascular disorders | 10/158 | 2/158 | 3/159 |
| Upper Respiratory tract InfectionInfections and infestations | 9/158 | 9/158 | 8/159 |
| bronchitisInfections and infestations | 6/158 | 5/158 | 2/159 |
| DiarrheoaGastrointestinal disorders | 2/158 | 5/158 | 3/159 |
| HeadacheNervous system disorders | 5/158 | 4/158 | 3/159 |
| AnaemiaBlood and lymphatic system disorders | 5/158 | 4/158 | 1/159 |
| HeadacheNervous system disorders | 5/158 | 3/158 | 3/159 |
| Psoriatic ArthropathyMusculoskeletal and connective tissue disorders | 0/158 | 3/158 | 5/159 |
| PsoriasisSkin and subcutaneous tissue disorders | 1/158 | 0/158 | 5/159 |
| Age, Categorical(Participants) | 210 mg Brodalumab | 140 mg Brodalumab | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 144 | 138 | 145 | 427 |
| >=65 years | 15 | 20 | 16 | 51 |
| Age, Continuous(years) | 210 mg Brodalumab | 140 mg Brodalumab | Placebo | Total |
|---|---|---|---|---|
| Mean | 49.1 ± 12.24 | 49.9 ± 12.80 | 48.1 ± 11.79 | 49 ± 12.28 |
| Sex: Female, Male(Participants) | 210 mg Brodalumab | 140 mg Brodalumab | Placebo | Total |
|---|---|---|---|---|
| Female | 70 | 80 | 80 | 230 |
| Male | 89 | 78 | 81 | 248 |
| Race (NIH/OMB)(Participants) | 210 mg Brodalumab | 140 mg Brodalumab | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 2 |
| Asian | 0 | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 155 | 152 | 152 | 459 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 6 | 5 | 13 |
| Region of Enrollment(participants) | 210 mg Brodalumab | 140 mg Brodalumab | Placebo | Total |
|---|---|---|---|---|
| Russian Federation | 22 | 22 | 27 | 71 |
| Hungary | 5 | 6 | 4 | 15 |
| United States | 35 | 37 | 35 | 107 |
| United Kingdom | 6 | 3 | 6 | 15 |
| Switzerland | 1 | 6 | 5 | 12 |
| Spain | 10 | 4 | 7 | 21 |
| Greece | 2 | 2 | 2 | 6 |
| Canada | 4 | 3 | 2 | 9 |
| Czech Republic | 2 | 8 | 9 | 19 |
| Belgium | 0 | 0 | 2 | 2 |
| Poland | 50 | 45 | 44 | 139 |
| Italy | 2 | 5 | 2 | 9 |
| Mexico | 5 | 3 | 4 | 12 |
| Slovakia | 5 | 5 | 5 | 15 |
| France | 4 | 2 | 2 | 8 |
| Bulgaria | 2 | 4 | 3 | 9 |
| Estonia | 4 | 3 | 2 | 9 |
Showing the first 100 of 152 sites across 17 countries.
Plan to share: Yes
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.