PsoriasisNCT07532486
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
A study testing Guselkumab in people with Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 10 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Xi-Bei CHEN, +86 15088611296, chenxb@zju.edu.cn
About this study
Official title: 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.
Read the 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%.
- Conditions
- Psoriasis
- Being tested
- Guselkumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called TREMFYA
Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.
GuselkumabDrug
Also called TREMFYA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to Week 98
Number of Participants with Abnormalities of Electrocardiogram (ECG)
Number of participants with abnormalities of electrocardiogram will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Week 12, 20, 52 and 86
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start10 Jul 2024
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532486
- Sponsor's protocol ID
- 2024-0032
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07532486
- Acronym / sponsor ID
- 2024-0032
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guselkumab in high-dose and extended-interval | Experimental | Drug: GuselkumabParticipants will receive 2 injections of active guselkumab as 200 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 8, 20, 36, 56, and 76. |
| Guselkumab in standard-dose | Active comparator | Drug: GuselkumabParticipants will receive 1 injection of active guselkumab 100 mg SC at Weeks 0, 4, 12, and q8w thereafter through Week 86. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabAlso: TREMFYAParticipants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76. | Drug | Guselkumab in high-dose and extended-interval |
| GuselkumabAlso: TREMFYAParticipants 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. | Drug | Guselkumab in standard-dose |
Primary outcome
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86
Time frame: 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.
Percentage of Participants Who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 86
Time frame: 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).
Number of Participants with Adverse Events (AE)
Time frame: Up to Week 98
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.
Number of Participants with Change from Baseline in Laboratory Abnormalities
Time frame: Up to Week 98
Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.
Number of Participants with Abnormalities of Electrocardiogram (ECG)
Time frame: Up to Week 98
Number of participants with abnormalities of electrocardiogram will be reported.
Number of Participants with Change from Baseline in Vital Signs
Time frame: Up to Week 98
Number of participants with change from baseline in vital signs (temperature, heart rate, respiratory rate, blood pressure) will be reported.
Number of Participants with Change from Baseline in Physical Examination
Time frame: Up to Week 98
Number of participants with change from baseline in physical examination will be reported.
Number of Participants with Change from Baseline in Concomitant Medications
Time frame: Up to Week 98
Number of participants with change from baseline in concomitant medications will be reported.
Number of Patients with Injection-site Reactions
Time frame: Up to Week 98
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.
Number of Patients with Allergic Reactions
Time frame: Up to Week 98
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.
Number of Participants with Infections
Time frame: Up to Week 98
Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported.
12 secondary outcomes
Percentages participants who Achieve a PASI 100, PASI 75, and PASI 50 Response at Week 86 and Over Time
Time frame: Week 12, 20, 52 and 86
Percentage of Participants who Achieve a PASI 90 Response Over Time
Time frame: Week 12, 20, 52 and 86
Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time
Time frame: Week 12, 20, 52 and 86
Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 12, 20, 52 and 86
Percentage of Participants with a Reduction of 5 or More Points in DLQI Score Over Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 12, 20, 52 and 86
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guselkumab in people with Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi-Bei CHEN (+86 15088611296, chenxb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86 (time frame: Week 86). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.