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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
.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.
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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 subcutaneous (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 Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear). | 12 weeks |
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12. | 12 weeks |
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12. | 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 | 35233 | 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 |
|
| Tucson |
| Arizona |
| 85710 |
| United States |
| Research Site | Hot Springs | Arkansas | 71913 | United States |
| Research Site | Bakersfield | California | 93309 | United States |
| Research Site | Beverly Hills | California | 90211 | United States |
| Research Site | Irvine | California | 92697 | United States |
| Research Site | Los Angeles | California | 90027 | United States |
| Research Site | Los Angeles | California | 90045 | United States |
| Research Site | Sacramento | California | 95816 | United States |
| Research Site | San Diego | California | 92103 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | Vista | California | 92083 | United States |
| Research Site | Denver | Colorado | 80209 | United States |
| Research Site | Denver | Colorado | 80210 | United States |
| Research Site | Denver | Colorado | 80239 | United States |
| Research Site | New Haven | Connecticut | 06511 | United States |
| Research Site | Aventura | Florida | 33180 | United States |
| Research Site | Jacksonville | Florida | 32216 | United States |
| Research Site | Miami | Florida | 33136 | United States |
| Research Site | Pembroke Pines | Florida | 33028 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Newnan | Georgia | 30263 | United States |
| Research Site | Snellville | Georgia | 30078 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Chicago | Illinois | 60654 | United States |
| Research Site | Skokie | Illinois | 60077 | United States |
| Research Site | Carmel | Indiana | 46032 | United States |
| Research Site | Plainfield | Indiana | 46168 | United States |
| Research Site | South Bend | Indiana | 46617 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Lake Charles | Louisiana | 70601 | United States |
| Research Site | Lake Charles | Louisiana | 70605 | United States |
| Research Site | New Orleans | Louisiana | 70112 | United States |
| Research Site | Rockville | Maryland | 20850 | United States |
| Research Site | Silver Spring | Maryland | 20902 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | North Andover | Massachusetts | 01845 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Fridley | Minnesota | 55432 | United States |
| Research Site | Omaha | Nebraska | 68144 | United States |
| Research Site | Henderson | Nevada | 89074 | United States |
| Research Site | Brooklyn | New York | 11209 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Rochester | New York | 14625 | United States |
| Research Site | Charlotte | North Carolina | 28210 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Beachwood | Ohio | 44122 | United States |
| Research Site | Columbus | Ohio | 43212 | United States |
| Research Site | Gahanna | Ohio | 43230 | United States |
| Research Site | South Euclid | Ohio | 44118 | United States |
| Research Site | Portland | Oregon | 97239 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Anderson | South Carolina | 29621 | United States |
| Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Site | Austin | Texas | 78759 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Houston | Texas | 77065 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78249 | United States |
| Research Site | West Jordan | Utah | 84088 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Research Site | Roanoke | Virginia | 24016 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| Research Site | Phillip | Australian Capital Territory | 2606 | Australia |
| Research Site | Kogarah | New South Wales | 2217 | Australia |
| Research Site | Benowa | Queensland | 4217 | Australia |
| Research Site | Gold Coast | Queensland | 4217 | Australia |
| Research Site | Woolloongabba | Queensland | 4102 | Australia |
| Research Site | Box Hill | Victoria | 3128 | Australia |
| Research Site | Carlton | Victoria | 3053 | Australia |
| Research Site | Parkville | Victoria | 3050 | Australia |
| Research Site | Graz | 8036 | Austria |
| Research Site | Innsbruck | 6020 | Austria |
| Research Site | Linz | 4020 | Austria |
| Research Site | Vienna | 1030 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vienna | 1130 | Austria |
| Research Site | Calgary | Alberta | T3A 2N1 | Canada |
| Research Site | Edmonton | Alberta | T5K 1X3 | Canada |
| Research Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 3Y1 | Canada |
| Research Site | Ajax | Ontario | L1S 7K8 | Canada |
| Research Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| Research Site | Mississauga | Ontario | L5H 1G9 | Canada |
| Research Site | Oakville | Ontario | L6J 7W5 | Canada |
| Research Site | Ottawa | Ontario | K2G 6E2 | Canada |
| Research Site | Peterborough | Ontario | K9J 1Z2 | Canada |
| Research Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Research Site | Windsor | Ontario | N8W 1E6 | Canada |
| Research Site | Windsor | Ontario | N8W 5L7 | Canada |
| Research Site | Montreal | Quebec | H3H 1V4 | Canada |
| Research Site | Brno | 656 91 | Czechia |
| Research Site | Jihlava | 586 33 | Czechia |
| Research Site | Nový Jičín | 741 01 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Prague | 180 81 | Czechia |
| Research Site | Ústí nad Labem | 401 13 | Czechia |
| Research Site | Amiens | 80504 | France |
| Research Site | Besançon | 25030 | France |
| Research Site | Brest | 29609 | France |
| Research Site | Clermont-Ferrand | 63000 | France |
| Research Site | Marseille | 13385 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Paris | 75475 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Rouen | 76031 | France |
| Research Site | Budapest | 1036 | Hungary |
| Research Site | Debrecen | 4012 | Hungary |
| Research Site | Kecskemét | 6000 | Hungary |
| Research Site | Miskolc | 3529 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Veszprém | 8200 | Hungary |
| Research Site | Amsterdam | 1105 AZ | Netherlands |
| Research Site | Breda | 4818 CK | Netherlands |
| Research Site | Nijmegen | 6525 GL | Netherlands |
| Research Site | Rotterdam | 3015 CA | Netherlands |
| Research Site | Gdynia | 81-384 | Poland |
| Research Site | Katowice | 40-040 | Poland |
| Research Site | Lodz | 90-265 | Poland |
| Research Site | Lodz | 90-436 | Poland |
| Research Site | Lublin | 20-080 | Poland |
| Research Site | Szczecin | 70-332 | Poland |
| Research Site | Tarnów | 33-100 | Poland |
| Research Site | Warsaw | 02-106 | Poland |
| Research Site | Warsaw | 04-141 | Poland |
| Research Site | Wroclaw | 50-088 | Poland |
| Research Site | Wroclaw | 50-368 | Poland |
| Research Site | Wroclaw | 51-153 | Poland |
| Research Site | Wroclaw | 51-318 | Poland |
| Research Site | Wroclaw | 53-658 | Poland |
| Research Site | Coimbra | 3000-075 | Portugal |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Porto | 4050 | Portugal |
| Research Site | Porto | 4200-319 | Portugal |
| Research Site | Córdoba | AndalucÃ-a | 14004 | Spain |
| Research Site | Seville | AndalucÃ-a | 41009 | Spain |
| Research Site | Alcañiz | Aragón | 44600 | Spain |
| Research Site | Manacor | Balearic Islands | 07500 | Spain |
| Research Site | Badalona | Cataluña | 08916 | Spain |
| Research Site | Barcelona | Cataluña | 08003 | Spain |
| Research Site | Barcelona | Cataluña | 08025 | Spain |
| Research Site | Barcelona | Cataluña | 08036 | Spain |
| Research Site | Barcelona | Cataluña | 08041 | Spain |
| Research Site | A Coruña | Galicia | 15001 | Spain |
| Research Site | Alcorcón | Madrid | 28922 | Spain |
| Research Site | Valencia | Valencia | 46014 | Spain |
| Research Site | Madrid | 28006 | Spain |
| 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 subcutaneous (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 subcutaneous (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, 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 Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear). | Posted | Count of Participants | Participants | 12 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12. | Posted | Count of Participants | Participants | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12. | 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 | 6 | 612 | 354 | 612 | ||
| 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 | 13 | 610 | 365 | 610 | ||
| EG002 | 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. | 4 | 300 | 177 | 300 | ||
| EG003 | Placebo | Administered by subcutaneous (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 | 8 | 309 | 165 | 309 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis Acute | Infections and infestations | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Blood Glucose Increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Diabetes Mellitus Inadequate Control | General disorders | Non-systematic Assessment |
| ||
| Dysponea | General disorders | Non-systematic Assessment |
| ||
| Escherichia Urinary tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ligament Rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Noncardiac Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Syncope | General disorders | Non-systematic Assessment |
| ||
| Alcohol Abuse | General disorders | Non-systematic Assessment |
| ||
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Angina Unstable | Cardiac disorders | Non-systematic Assessment |
| ||
| Anteriosclerosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Carbon Monoxide Poisining | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Cerbebral Infarction | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Chondromalacia | General disorders | Non-systematic Assessment |
| ||
| Chondropathy | General disorders | Non-systematic Assessment |
| ||
| Drug Detoxification | General disorders | Non-systematic Assessment |
| ||
| Fibromyalgia | General disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Joint Capsule Rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ligament Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Vertigo | General disorders | Non-systematic Assessment |
| ||
| Acute Coronary Syndrome | Vascular disorders | Non-systematic Assessment |
| ||
| Suicide attempt | Psychiatric 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 |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Viral Upper respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Non-systematic Assessment |
| ||
| Oral Herpes | Infections and infestations | Non-systematic Assessment |
| ||
| Conjuncitvitus | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis Viral | Infections and infestations | Non-systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Tooth Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis Media | Infections and infestations | Non-systematic Assessment |
| ||
| Skin Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in Extremity | 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 |
| ||
| Muskuloskelital Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Joint Swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritus Generalized | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Intertrigo | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Migrane | Nervous system disorders | Non-systematic Assessment |
| ||
| Sinus headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Peripheral Swelling | General disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Odema Peripheral | General disorders | Non-systematic Assessment |
| ||
| Injection Site Pain | General disorders | Non-systematic Assessment |
| ||
| Non-cardiac Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Muscle Strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Joint Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hyperuricaemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Gout | 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
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Netherlands |
|
| Austria |
|
| Hungary |
|
| United States |
|
| Poland |
|
| Australia |
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| France |
|
| Portugal |
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| Spain |
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