A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis

An Open-label, Parallel Group, Multicenter Study Evaluating the Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants With Moderate to Severe Plaque Psoriasis

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Guselkumab; Drug: Guselkumab

Detailed Description

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%.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xi-Bei CHEN; Phone Number: +86 15088611296; Email: chenxb@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Xi-Bei CHEN; Phone Number: +86 15088611296; Email: chenxb@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis] PsA) for at least 6 months before the first administration of study drug.
• Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >=3, or Investigator's Global Assessment (IGA) >=3, or Affected Body Surface Area (BSA) >= 10% at baseline (Week 0).
• Be suitable for receiving systemic treatment of psoriasis, as whether biologic-naïve or biologic-experienced participant.
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections.
• Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination.
• Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug.
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug.
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Exclusion Criteria:

• Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular).
• Currently has drug-induced psoriasis (e.g., newly developed psoriasis or exacerbation of psoriasis due to treatment with β-blockers, calcium channel blockers, or lithium).
• Has a history of or current signs or symptoms of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter/minute [mL/min]); significant, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
• Currently has a or has a history of malignancy within 5 years before screening (exceptions are nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration and cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before screening, or malignancy, which is considered cured with minimal risk of recurrence).
• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
• Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, recurrent sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infection (example, recurrent pyelonephritis, recurrent cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers.
• Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guselkumab in high-dose and extended-interval; 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.	Drug: Guselkumab; Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.; Other Names: TREMFYA; Drug: Guselkumab; 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.; Other Names: TREMFYA
Active Comparator: Guselkumab in standard-dose; Participants will receive 1 injection of active guselkumab 100 mg SC at Weeks 0, 4, 12, and q8w thereafter through Week 86.	Drug: Guselkumab; Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.; Other Names: TREMFYA; Drug: Guselkumab; 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.; Other Names: TREMFYA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; guselkumab
• Other Study ID Numbers: 2024-0032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No