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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSO3006 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-002022-37 | EudraCT Number |
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The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Guselkumab: Placebo) | Experimental | Participants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind. |
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| Group 2 (Placebo: Guselkumab) | Experimental | Partcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | 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 participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study. | Week 16 |
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), 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 (no psoriasis) 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. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16 | 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 participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Renstar Medical Research | Ocala | Florida | 34470 | United States | ||
| Arlington Dermatology |
| 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. | |
| 30887876 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28. |
| FG001 | Guselkumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo Controlled Period(Week[wk] 0-16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2016 | Aug 9, 2018 |
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| Placebo | Drug | Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device. |
|
| Week 16 |
| Percentage of Participants Who Achieve a PASI 100 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | Week 16 |
| Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16 | 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 participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | Week 16 |
| Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with >=50% and >= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | Week 16 |
| Percent Improvement From Baseline in PASI Score at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Baseline and Week 16 |
| Percent Improvement From Baseline in PASI Score Through Week 40 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. | Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval) |
| Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. | Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval) |
| Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and >= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. | Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval) |
| Rolling Meadows |
| Illinois |
| 60008 |
| United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40241 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| University of Pittsburgh Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Partners | Johnston | Rhode Island | 02919 | United States |
| Virginia Clinical Research | Norfolk | Virginia | 23502 | United States |
| Dr. Chih ho Hong Medical | Surrey | British Columbia | V3R 6A7 | Canada |
| Dermatrials Research | Hamilton | Ontario | L8N 1Y2 | Canada |
| DermEdge Research | Mississauga | Ontario | L4Y 4C5 | Canada |
| Niepubliczny Zaklad Opieki Zdrowotnej Osteo-Medic s.c. Artur Racewicz i Jerzy Supronik | Bialystok | 15 351 | Poland |
| Szpital Uniwersytecki nr 1 im Dr A Jurasza | Bydgoszcz | 85 094 | Poland |
| Wromedica Irena Bielicka, Janusz Szczepanik S.C. | Wroclaw | 51-685 | Poland |
| Derived |
| Ferris LK, Ott E, Jiang J, Hong HC, Li S, Han C, Baran W. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020 Mar;31(2):152-159. doi: 10.1080/09546634.2019.1587145. Epub 2019 Mar 19. |
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
| FG002 | Placebo to Guselkumab | Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Active Treatment and Follow up (wk16-40) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28. |
| BG001 | Guselkumab | Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | 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 participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study. | Full analysis set (FAS) included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Percentage of participants | Week 16 |
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| Primary | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), 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 (no psoriasis) 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. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16 | 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 participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieve a PASI 100 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16 | 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 participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with >=50% and >= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. | FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percent Improvement From Baseline in PASI Score at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. | FAS included all randomized participants who received at least 1 injection of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero. | Posted | Mean | Standard Deviation | Percent improvement | Baseline and Week 16 |
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| Secondary | Percent Improvement From Baseline in PASI Score Through Week 40 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), 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 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. | FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero. | Posted | Mean | Standard Deviation | Percent improvement | Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval) |
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| Secondary | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. | FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data. | Posted | Number | Percentage of participants | Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval) |
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| Secondary | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and >= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. | FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data. | Posted | Number | Percentage of participants | Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval) |
|
Up to Week 40
Not provided
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 | Placebo (Week 0-16) | Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28. | 0 | 16 | 0 | 16 | 12 | 16 |
| EG001 | Guselkumab (Week 0-16) | Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. | 0 | 62 | 2 | 62 | 38 | 62 |
| EG002 | Placebo to Guselkumab (Week 16-40) | Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28. | 0 | 13 | 2 | 13 | 8 | 13 |
| EG003 | Guselkumab (Week 16-40) | Participants received placebo at Week 16, and 100 mg guselkumab at Week 20 and 28. | 0 | 61 | 1 | 61 | 24 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Left Ventricular Hypertrophy | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Coldness | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Oedema | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Pruritus | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Postmenopausal Haemorrhage | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vaginal Cyst | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urticaria Pressure | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Immunology General | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2017 | Aug 9, 2018 | SAP_001.pdf |
| 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 |
|---|---|
| C000588857 | guselkumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Hispanic or Latino |
|
| Other |
|
| White Non-Hispanic |
|
| Poland |
|
| United States |
|
| OG001 |
| Guselkumab |
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Guselkumab |
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|
|
|
| Guselkumab |
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|
|
| OG001 | Guselkumab | Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|
| OG001 |
| Guselkumab |
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|
| OG001 | Guselkumab | Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. |
|
|