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Sponsor decision
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The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.
A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.
A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
This study assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.
A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.
A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 210 mg brodalumab | Experimental | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. |
|
| 140 mg brodalumab | Experimental | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. |
|
| ustekinumab | Active Comparator | Administered by subcutaneous (SC) injection per the labeled dosing regimen. |
|
| Placebo | Placebo Comparator | Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 210 mg brodalumab | Drug | 210 mg brodalumab administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed. | 12 weeks |
| Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo | Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35205 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39264399 | Derived | Lebwohl MG, Armstrong AW, Alexis AF, Lain EL, Jacobson AA. Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses. Dermatol Ther (Heidelb). 2024 Oct;14(10):2709-2726. doi: 10.1007/s13555-024-01264-3. Epub 2024 Sep 12. | |
| 34606048 | Derived | Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 210 mg Brodalumab | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. 210 mg brodalumab: 210 mg brodalumab administered SC |
| FG001 | 140 mg Brodalumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 140 mg brodalumab | Drug | 140 mg brodalumab administered SC |
|
|
| ustekinumab | Drug | 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. |
|
|
| placebo | Drug | placebo administered SC |
|
| Mobile |
| Alabama |
| 36608 |
| United States |
| Research Site | Phoenix | Arizona | 85023 | United States |
| Research Site | Beverly Hills | California | 90212 | United States |
| Research Site | Burbank | California | 91505 | United States |
| Research Site | Encino | California | 91436 | United States |
| Research Site | Fremont | California | 94538 | United States |
| Research Site | Fullerton | California | 92835 | United States |
| Research Site | Irvine | California | 92614 | United States |
| Research Site | Los Angeles | California | 90036 | United States |
| Research Site | Riverside | California | 92505 | United States |
| Research Site | Sacramento | California | 95819 | United States |
| Research Site | San Diego | California | 92103 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | San Francisco | California | 94118 | United States |
| Research Site | Denver | Colorado | 80220 | United States |
| Research Site | Farmington | Connecticut | 06030 | United States |
| Research Site | Trumbull | Connecticut | 06611 | United States |
| Research Site | Boca Raton | Florida | 33486 | United States |
| Research Site | Coral Gables | Florida | 33134 | United States |
| Research Site | Hollywood | Florida | 33021 | United States |
| Research Site | Jacksonville | Florida | 32204 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Ocala | Florida | 34471 | United States |
| Research Site | Tamarac | Florida | 33321 | United States |
| Research Site | Alpharetta | Georgia | 30022 | United States |
| Research Site | Atlanta | Georgia | 30327 | United States |
| Research Site | Macon | Georgia | 31217 | United States |
| Research Site | Boise | Idaho | 83704 | United States |
| Research Site | Arlington Heights | Illinois | 60005 | United States |
| Research Site | Champaign | Illinois | 61820 | United States |
| Research Site | Maywood | Illinois | 60153 | United States |
| Research Site | Normal | Illinois | 61761 | United States |
| Research Site | Wheaton | Illinois | 60189 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | New Albany | Indiana | 47150 | United States |
| Research Site | Overland Park | Kansas | 66202 | United States |
| Research Site | Overland Park | Kansas | 66215 | United States |
| Research Site | Louisville | Kentucky | 40217 | United States |
| Research Site | Owensboro | Kentucky | 42303 | United States |
| Research Site | Worcester | Massachusetts | 01605 | United States |
| Research Site | Ann Arbor | Michigan | 48103 | United States |
| Research Site | Clarkston | Michigan | 48346 | United States |
| Research Site | Clinton Township | Michigan | 48038 | United States |
| Research Site | Henderson | Nevada | 89074 | United States |
| Research Site | Las Vegas | Nevada | 89144 | United States |
| Research Site | East Windsor | New Jersey | 08520 | United States |
| Research Site | Hoboken | New Jersey | 07030 | United States |
| Research Site | Verona | New Jersey | 07044 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Rochester | New York | 14623 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | High Point | North Carolina | 27262 | United States |
| Research Site | Cincinnati | Ohio | 45249 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Lake Oswego | Oregon | 97035 | United States |
| Research Site | Portland | Oregon | 97210 | United States |
| Research Site | Exton | Pennsylvania | 19341 | United States |
| Research Site | Johnston | Rhode Island | 02919 | United States |
| Research Site | Greer | South Carolina | 29650 | United States |
| Research Site | Bartlett | Tennessee | 38134 | United States |
| Research Site | Nashville | Tennessee | 37205 | United States |
| Research Site | Bellaire | Texas | 77401 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Houston | Texas | 77004 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Houston | Texas | 77082 | United States |
| Research Site | Webster | Texas | 77598 | United States |
| Research Site | Salt Lake City | Utah | 84132 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Richmond | Virginia | 23294 | United States |
| Research Site | Spokane | Washington | 99204 | United States |
| Research Site | Clarksburg | West Virginia | 26301 | United States |
| Research Site | Camperdown | New South Wales | 2050 | Australia |
| Research Site | Darlinghurst | New South Wales | 2010 | Australia |
| Research Site | Kogarah | New South Wales | 2217 | Australia |
| Research Site | St Leonards | New South Wales | 2065 | Australia |
| Research Site | Sydney | New South Wales | 2000 | Australia |
| Research Site | Westmead | New South Wales | 2145 | Australia |
| Research Site | Hectorville | South Australia | 5073 | Australia |
| Research Site | Fremantle | Western Australia | 6160 | Australia |
| Research Site | Bruges | 8000 | Belgium |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Montigny-le-Tilleul | 6110 | Belgium |
| Research Site | Calgary | Alberta | T2G 1B1 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Research Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Research Site | Winnipeg | Manitoba | R3C 1R4 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Research Site | Halifax | Nova Scotia | B3H 0A2 | Canada |
| Research Site | Barrie | Ontario | L4M 6L2 | Canada |
| Research Site | Hamilton | Ontario | L8N 1V6 | Canada |
| Research Site | Markham | Ontario | L3P 1A8 | Canada |
| Research Site | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Research Site | Toronto | Ontario | M3H 5Y8 | Canada |
| Research Site | Toronto | Ontario | M5S 3B4 | Canada |
| Research Site | Toronto | Ontario | M8X 1Y9 | Canada |
| Research Site | Drummondville | Quebec | J2B 5L4 | Canada |
| Research Site | Montreal | Quebec | H3Z 2S6 | Canada |
| Research Site | Saint-Hyacinthe | Quebec | J2S 6L6 | Canada |
| Research Site | Créteil | 94010 | France |
| Research Site | Limoges | 87000 | France |
| Research Site | Nice | 06200 | France |
| Research Site | Poitiers | 86000 | France |
| Research Site | Saint-Priest-en-Jarez | 42270 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Vandœuvre-lès-Nancy | 54511 | France |
| Research Site | Chaïdári | Athens | 12462 | Greece |
| Research Site | Athens | 16121 | Greece |
| Research Site | Ioannina | 45500 | Greece |
| Research Site | Larissa | 41110 | Greece |
| Research Site | Marousi | 15123 | Greece |
| Research Site | Thessaloniki | 54643 | Greece |
| Research Site | Thessaloniki | 56429 | Greece |
| Research Site | Békéscsaba | 5600 | Hungary |
| Research Site | Budapest | 1085 | Hungary |
| Research Site | Gyula | 5700 | Hungary |
| Research Site | Szeged | 6720 | Hungary |
| Research Site | Szolnok | 5000 | Hungary |
| Research Site | Szombathely | 9700 | Hungary |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Milan | 20122 | Italy |
| Research Site | Milan | 48018 | Italy |
| Research Site | Roma | 00133 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Riga | 1001 | Latvia |
| Research Site | Riga | 1003 | Latvia |
| Research Site | Riga | LV-1013 | Latvia |
| Research Site | Ventspils | 3601 | Latvia |
| Research Site | Bialystok | 15-879 | Poland |
| Research Site | Dąbrówka | 62-069 | Poland |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Iwonicz-Zdrój | 38-440 | Poland |
| Research Site | Katowice | 40-954 | Poland |
| Research Site | Krakow | 30-510 | Poland |
| Research Site | Krakow | 31-501 | Poland |
| Research Site | Lodz | 90-242 | Poland |
| Research Site | Lublin | 20-406 | Poland |
| Research Site | Poznan | 60-539 | Poland |
| Research Site | Stalowa Wola | 37-450 | Poland |
| Research Site | Åšwidnik | 21-040 | Poland |
| Research Site | Warsaw | 01-192 | Poland |
| Research Site | Warsaw | 02-201 | Poland |
| Research Site | Moscow | 107076 | Russia |
| Research Site | Moscow | 119991 | Russia |
| Research Site | Moscow | 121614 | Russia |
| Research Site | Saint Petersburg | 191015 | Russia |
| Research Site | Saint Petersburg | 194044 | Russia |
| Research Site | Saratov | 410026 | Russia |
| Research Site | Yekaterinburg | 620076 | Russia |
| 32207067 | Derived | Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4. |
| 30471012 | Derived | McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z. |
| 30328108 | Derived | Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27. |
| 26422722 | Derived | Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824. |
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
| FG002 | Ustekinumab | Administered by subcutaneous (SC) injection per the labeled dosing regimen. ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. |
| FG003 | Placebo | Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. 210 mg brodalumab: 210 mg brodalumab administered SC placebo: placebo administered SC |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 210 mg Brodalumab | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. 210 mg brodalumab: 210 mg brodalumab administered SC |
| BG001 | 140 mg Brodalumab | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. 140 mg brodalumab: 140 mg brodalumab administered SC |
| BG002 | Ustekinumab | Administered by subcutaneous (SC) injection per the labeled dosing regimen. ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. |
| BG003 | Placebo | Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. 210 mg brodalumab: 210 mg brodalumab administered SC placebo: placebo administered SC |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed. | Posted | Count of Participants | Participants | 12 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo | Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear). | sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo. | Posted | Count of Participants | Participants | 12 weeks |
|
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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 | 210 mg Brodalumab | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. 210 mg brodalumab: 210 mg brodalumab administered SC | 9 | 624 | 353 | 624 | ||
| EG001 | 140 mg Brodalumab | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. 140 mg brodalumab: 140 mg brodalumab administered SC | 10 | 629 | 329 | 629 | ||
| EG002 | Placebo | Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. 210 mg brodalumab: 210 mg brodalumab administered SC placebo: placebo administered SC | 3 | 315 | 152 | 315 | ||
| EG003 | Ustekinumab | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. | 2 | 313 | 168 | 313 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Localised Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Altered State of Consciousness | General disorders | Non-systematic Assessment |
| ||
| Appendicitus | Immune system disorders | Non-systematic Assessment |
| ||
| Arthritis | General disorders | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Bladder Cancer | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Cholecystitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dermatitis Contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Diverticulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Encephalopathy | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Erythrodermic Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| ||
| Meningitis Cryptoccocal | Infections and infestations | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Nervous system disorders | Non-systematic Assessment |
| ||
| Overdose | General disorders | Non-systematic Assessment |
| ||
| Peritonsillar Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Rash Papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis Contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Influenza Like Illness | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Injection Site Pain | General disorders | Non-systematic Assessment |
| ||
| headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Investigations | Investigations | Non-systematic Assessment |
| ||
| Injury and Complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Injection Site erythema | General disorders | Non-systematic Assessment |
| ||
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Metabolism and Nutritional Disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 510-259-5284 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571216 | brodalumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| Latvia |
|
| Russia |
|
| Hungary |
|
| Belgium |
|
| United States |
|
| Poland |
|
| Italy |
|
| Australia |
|
| France |
|
|
|