New study explores best guselkumab dose for psoriasis in chinese patients
NCT ID NCT07532486
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares the effectiveness and safety of different doses and schedules of guselkumab in 400 Chinese adults with moderate to severe plaque psoriasis. Participants will receive either a high dose, an extended-interval dose, or the standard dose. The goal is to find the best way to control psoriasis symptoms over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, China
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