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

NCT07532486 | Recruiting

• 1 other identifier: 2024-0032
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (12)

• Percentages participants who Achieve a PASI 100, PASI 75, and PASI 50 Response at Week 86 and Over Time

  Week 12, 20, 52 and 86

• Percentage of Participants who Achieve a PASI 90 Response Over Time

  Week 12, 20, 52 and 86

• Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time

  Week 12, 20, 52 and 86

• Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time

  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

  Week 86

Study Arms (2)

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.

Drug: Guselkumab

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.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.

Also known as: TREMFYA

Guselkumab in high-dose and extended-interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xi-Bei CHEN

CONTACT

+86 15088611296; chenxb@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: July 10, 2024
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-02

Locations

CN (1)