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The purpose of this study is to evaluate the efficacy, safety, tolerability and drug survival of guselkumab in high-dose and extended-interval versus standard-dose in Chinese participants with moderate to severe plaque psoriasis.
The study consists of Screening Phase (4 weeks before administration of study drug), Active Treatment Phase (Week 0-Week 86), Follow-up Phase (Week 86-Week 98). During various study periods, safety assessments (example [e.g] recording of adverse events, Vital signs, Tuberculosis evaluation, Chest radiograph, Urine pregnancy test); Efficacy assessments (e.g PASI, IGA, ss-IGA, NAPSI, DLQI); Clinical laboratory assessments (e.g hematology, chemistry); Biomarkers/Genetic evaluations, will be performed per the study procedures. The primary hypotheses are that guselkumab treatment with high-dose and extended-interval is non-inferior to standard dose as assessed by proportion of participants achieving PASI 90 and IGA 0/1 response at Week 86 with noninferiority margin of 13%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab in high-dose and extended-interval | Experimental | Participants will receive 2 injections of active guselkumab as 200 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 8, 20, 36, 56, and 76. |
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| Guselkumab in standard-dose | Active Comparator | Participants will receive 1 injection of active guselkumab 100 mg SC at Weeks 0, 4, 12, and q8w thereafter through Week 86. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86 | 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 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. | Week 86 |
| Percentage of Participants Who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 86 | 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 86 |
| Number of Participants with Adverse Events (AE) | An AE is any untoward medical occurrence in a participant during a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study. | Up to Week 98 |
| 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 98 |
| Number of Participants with Abnormalities of Electrocardiogram (ECG) | Number of participants with abnormalities of electrocardiogram will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages participants who Achieve a PASI 100, PASI 75, and PASI 50 Response at Week 86 and Over Time | 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 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%-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 could range from 0 (no psoriasis) 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi-Bei CHEN | Contact | +86 15088611296 | chenxb@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| Guselkumab | Drug | Participants will receive 1 injection of active guselkumab (100 mg, SC) at Weeks 0, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76 and 84. |
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| Up to Week 98 |
| 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 98 |
| Number of Participants with Change from Baseline in Physical Examination | Number of participants with change from baseline in physical examination will be reported. | Up to Week 98 |
| Number of Participants with Change from Baseline in Concomitant Medications | Number of participants with change from baseline in concomitant medications will be reported. | Up to Week 98 |
| Number of Patients with Injection-site Reactions | An injection-site reaction is any favorable or unintended sigh 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 98 |
| Number of Patients with Allergic Reactions | Number of participants with allergic reactions (skin symptoms such as urticaria, erythema, and itching; respiratory symptoms such as dyspnea, wheezing; gastrointestinal symptoms such as nausea, vomiting, and abdominal pain; and severe allergic symptoms including angioedema, sudden drop of blood pressure, or even anaphylactic shock) will be reported. | Up to Week 98 |
| 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 98 |
| Week 12, 20, 52 and 86 |
| 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. 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score. | Week 12, 20, 52 and 86 |
| 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 12, 20, 52 and 86 |
| 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. | Week 12, 20, 52 and 86 |
| Percentage of Participants who Maintain PASI 90 Responders at Week 86 Among Participants who were PASI 90 Responders at Week 48 | 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 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score. | Week 86 |
| Percentage of Participants who Maintain IGA Score of Cleared (0) or Minimal (1) at Week 86 Among Participants who Achieved IGA 0/1 at Week 48 | Percentage of participants who maintain IGA score of cleared (0) or minimal (1) at Week 86 among participants who achieved IGA0/1 at Week 48 will be reported | Week 86 |
| 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) at Week 86 and 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 12, 20, 52 and 86 |
| 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 12, 20, 52 and 86 |
| 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 12, 20, 52 and 86 |
| Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 36 and 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). | Week 12, 20, 36, 52 and 86 |
| Percentage of Participants with a 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 12, 20, 36, 52 and 86 |
| Percentage of Participants who Maintain PASI value ≤0.9 at Week 52 Among Participants who had achieved at Week 20 | 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 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. | Week 12, 20, 52 and 86 |
| 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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