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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSO4009 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in the treatment of Chinese participants with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Guselkumab | Experimental | Participants will receive guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, and then every 8 weeks (q8w) through Week 44. Participants will receive matching placebo at Week 16. |
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| Group 2: Placebo | Placebo Comparator | Participants will receive placebo SC injection for guselkumab at Weeks 0, 4, and 12, and then cross over at Week 16 to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and q8w thereafter through Week 44. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab 100 mg will be administered as a SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=)90 percent (%) improvement in PASI score. | Week 16 |
| Percentage of Participants who Achieve 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 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). | Week 16 |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study. | Up to Week 56 |
| Number of Participants with Serious Adverse Events (SAEs) | SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | Up to Week 56 |
| Number of Participants with Reasonably Related Adverse Events (AEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve a PASI 100, PASI 75, and PASI 50 Response Over Time | 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 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 100, 75, and 50 response is defined as 100%, >=75%, and >=50% improvement in PASI score respectively. |
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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 |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100191 | China | |||
| Beijing Tongren Hospital, CMU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40921728 | Derived | Huang K, Geng S, Tao X, Sun L, Ji C, Yang B, Lu Y, Xiao R, Zhang C, Zhang F, Lu Q, Zheng J, Wang H, Shi Y, Li Z, Yan W, Zhang L, Tao J, Zhang S, Yang X, Cheng H, Xu J, Su J, Zhang Z, Song Z, Wang L, Wang R, Zhang T, Zhao W, Huang Y, Chen M, Dong Z, Lyu S, Zheng M. Efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled trial. Chin Med J (Engl). 2025 Sep 8. doi: 10.1097/CM9.0000000000003771. Online ahead of print. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Drug | Matching placebo will be administered as a SC injection. |
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study. |
| Up to Week 56 |
| Number of Participants with AEs Leading to Discontinuation of Study Intervention | Number of participants with AEs leading to discontinuation of study intervention will be reported. | Up to Week 56 |
| Number of Participants with Infections | Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported. | Up to Week 56 |
| Number of Participants with Serious Hypersensitivity Reactions | Number of participants with serious hypersensitivity reactions (such as anaphylaxis, urticaria, pruritis, angioedema, wheezing, dyspnea, or hypotension) will be reported. | Up to Week 56 |
| Number of Participants with Injection-site Reactions | An injection-site reaction is any unfavorable or unintended sign that occurs at the study drug injection site. Injection sites will be evaluated for reactions and any injection-site reaction will be recorded as an AE. | Up to Week 56 |
| Number of Participants with Change from Baseline in Laboratory Abnormalities | Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported. | Up to Week 56 |
| Number of Participants with Laboratory Abnormalities with Maximum Toxicity Grades | Number of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades will be reported. A higher grade indicates more severity. | Up to Week 56 |
| Number of Participants with Change from Baseline in Vital Signs | Number of participants with change from baseline in vital signs (temperature, heart rate, respiratory rate, blood pressure) will be reported. | Up to Week 56 |
| Week 0, 4, 12, 16, 20, 28, 36, 44, 48 |
| Percentage of Participants who Achieve a PASI 90 Response Over Time | 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score. | Week 0, 4, 12, 16, 20, 28, 36, 44, 48 |
| Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time | Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) over time will be reported. | Week 0, 4, 12, 16, 20, 28, 36, 44, 48 |
| Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease. | Baseline, Week 4, 16, 28, 48 |
| Percentage of Participants who Maintain PASI 90 Response at Week 48 Among Participants who were PASI 90 Responders at Week 16 in Guselkumab Group | 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score. | Week 48 |
| Percentage of Participants who Maintain IGA Score of Cleared (0) or Minimal (1) at Week 48 Among Participants who Achieved IGA 0/1 at Week 16 in Guselkumab Group | Percentage of participants who maintain IGA score of cleared (0) or minimal (1) at Week 48 among participants who achieved IGA 0/1 at Week 16 in guselkumab group will be reported. | Week 48 |
| Percentage of Participants who Achieve an IGA Score of Cleared (0) and an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) Over Time | Percentage of participants who achieve an IGA score of cleared (0) and an IGA score of mild or better (<=2) over time will be reported. | Week 0, 4, 12, 16, 20, 28, 36, 44, 48 |
| Percentage of Participants who Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1 | Percentage of participants who achieve a DLQI score of 0 or 1 over time among participants with baseline DLQI >1 will be reported. | Week 0, 4, 16, 28, 48 |
| Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time | Percentage of participants with a reduction of 5 or more points in DLQI score over time will be reported. | Week 0, 4, 16, 28, 48 |
| Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Over Time Among Participants with Nail Psoriasis at Baseline | The NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0-4 (A higher score indicates more severity). The sum of these scores is the total NAPSI score (0=no psoriasis to 8=psoriasis present in all 4 quadrants of the target nail). | Baseline, Week 16, 28, 36, 48 |
| Percentage of Participants with an Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) Over Time Among Participants with Scalp Psoriasis and an ss-IGA Score >=2 at Baseline | The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4). | Week 0, 16, 28, 36, 48 |
| Serum Concentration of Guselkumab Over Time | Serum concentrations of guselkumab over time will be reported. | Week 0, 4, 16, 20, 36, 44, 56 |
| Number of Participants with Antibodies to Guselkumab | Number of participants with antibodies to guselkumab through week 56 will be reported. | Week 0, 16, 44, 56 |
| Maximum Titer of Antibodies to Guselkumab Through Week 56 | Maximum titer of antibodies to guselkumab through Week 56 will be reported. | Week 0, 16, 44, 56 |
| Beijing |
| 100730 |
| China |
| Xiangya Hospital Central South University | Changsha | 410008 | China |
| The second Xiangya Hospital of Central South University | Changsha | 410011 | China |
| West China Hospital,Sichuan University | Chengdu | 610041 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | China |
| The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing | 400038 | China |
| Fujian Medical University | Fuzhou | 350005 | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | 510091 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310004 | China |
| The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | 310016 | China |
| The 1st affiliated hospital of Anhui Medical University | Hefei | 230022 | China |
| Skin Disease Hospital of Shandong Province | Jinan | 250022 | China |
| Jiangsu Province Hospital | Nanjing | 210029 | China |
| Hospital of Dermatology, Chinese Academy of Medical Science | Nanjing | 210042 | China |
| Shanghai Ruijin Hospital | Shanghai | 200025 | China |
| Huashan Hospital Fudan University | Shanghai | 200040 | China |
| Shanghai skin disease hospital | Shanghai | 200050 | China |
| University of Hong Kong-Shenzhen Hospital | Shenzhen | 518053 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | 300120 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | 325000 | China |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan | 430022 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | 710004 | China |
| Henan province people's hospital | Zhengzhou | 450003 | China |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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