Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSO3003 | Other Identifier | Janssen Research & Development, LLC | |
| 2014-000721-20 | EudraCT Number |
Not provided
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Not provided
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The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.
This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label ustekinumab | Experimental |
| |
| Double-blind guselkumab | Experimental |
| |
| Double-blind ustekinumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | 45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 28 through Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37906417 | Derived | Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31. | |
| 37071038 |
Not provided
Not provided
Study consists of 2 periods: Open label run-in (Period 1) and blinded phase (Period 2). Participants were enrolled in open label run-in period only. Participants completed the open label run-in period entered into blinded phase period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ustekinumab (Open Label Run-in) | All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open Label Run-in (Week 0 to Week 16) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Guselkumab | Drug | 100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44. |
|
| Placebo for ustekinumab | Drug | Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab. |
|
| Placebo for guselkumab | Drug | Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab. |
|
| Week 28 through Week 40 |
| Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 28 through Week 40 |
| Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 28 |
| Bakersfield |
| California |
| United States |
| Los Angeles | California | United States |
| Santa Monica | California | United States |
| Coral Gables | Florida | United States |
| Ocala | Florida | United States |
| Alpharetta | Georgia | United States |
| Atlanta | Georgia | United States |
| Arlington Heights | Illinois | United States |
| Chicago | Illinois | United States |
| Skokie | Illinois | United States |
| Indianapolis | Indiana | United States |
| Plainfield | Indiana | United States |
| Louisville | Kentucky | United States |
| Boston | Massachusetts | United States |
| Troy | Michigan | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Portland | Oregon | United States |
| Pittsburgh | Pennsylvania | United States |
| Johnston | Rhode Island | United States |
| Nashville | Tennessee | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Webster | Texas | United States |
| Norfolk | Virginia | United States |
| Spokane | Washington | United States |
| Fremantle | Australia |
| Victoria Park | Australia |
| Woden | Australia |
| Woolloongabba | Australia |
| Surrey | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Moncton | New Brunswick | Canada |
| Halifax | Nova Scotia | Canada |
| Ajax | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Berlin | Germany |
| Bonn | Germany |
| Essen | Germany |
| Gera | Germany |
| Hamburg | Germany |
| Leipzig | Germany |
| Lübeck | Germany |
| Mahlow | Germany |
| Münster | Germany |
| Witten | Germany |
| Bialystok | Poland |
| Bydgoszcz | Poland |
| Gdansk | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Olsztyn | Poland |
| Poznan | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Chelyabinsk | Russia |
| Krasnodar | Russia |
| Lipetsk | Russia |
| Saint Petersburg | Russia |
| Stavropol | Russia |
| Ufa | Russia |
| Yekaterinburg | Russia |
| Anyang | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
| A Coruña | Spain |
| Alcorcón | Spain |
| Alicante | Spain |
| Barcelona | Spain |
| Madrid | Spain |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Dudley | United Kingdom |
| Dundee | United Kingdom |
| London | United Kingdom |
| Salford | United Kingdom |
| Derived |
| Campbell K, Li K, Yang F, Branigan P, Elloso MM, Benson J, Orlovsky Y, Chen Y, Garcet S, Krueger JG. Guselkumab More Effectively Neutralizes Psoriasis-Associated Histologic, Transcriptomic, and Clinical Measures than Ustekinumab. Immunohorizons. 2023 Apr 1;7(4):273-285. doi: 10.4049/immunohorizons.2300003. |
| FG001 | 100 mg Guselkumab (Randomized) | Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40. |
| FG002 | Ustekinumab (Randomized) | Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44. |
| FG003 | Ustekinumab (Nonrandomized Open Label Continuation) | Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Blinded Phase (Week 16 to Week 44) |
|
|
Baseline analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ustekinumab (Open Label Run-in) | All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w. |
| 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 |
| |||||||||||||||||||||||
| 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 | Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16. | Posted | Mean | Standard Deviation | visits | Week 28 through Week 40 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. | Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16. | Posted | Mean | Standard Deviation | visits | Week 28 through Week 40 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16. | Posted | Mean | Standard Deviation | visits | Week 28 through Week 40 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16. | Posted | Number | percentage of participants | Week 28 |
|
Up to Week 60
Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ustekinumab (Open Label Run-in) | All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w. | 11 | 871 | 80 | 871 | ||
| EG001 | 100 mg Guselkumab (Randomized) | Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40. | 9 | 135 | 37 | 135 | ||
| EG002 | Ustekinumab (Randomized) | Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44. | 6 | 133 | 33 | 133 | ||
| EG003 | Ustekinumab (Nonrandomized Open Label Continuation) | Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40. | 20 | 585 | 60 | 585 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Sinus Node Dysfunction | Cardiac disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Retinal Artery Embolism | Eye disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Paraspinal Abscess | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Scapula Fracture | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Large Intestinal Stenosis | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA Version 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| 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 |
|---|---|
| D000069549 | Ustekinumab |
| C000588857 | guselkumab |
| 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
| Withdrawal by Subject |
|
| Other |
|
| Death |
|
| Completed Safety follow-up |
|
| Russia |
|
| Spain |
|
| United Kingdom |
|
| Canada |
|
| United States |
|
| Australia |
|
| Korea, Republic Of |
|
| Taiwan, Province Of China |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|