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Compares treatment options for Psoriasis
Official title 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
ClinicalTrials.gov ID: NCT07532486
What this study is testing
What is Guselkumab?
Guselkumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for psoriasis.
Also referred to as TREMFYA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score \>=3, or Investigator's Global Assessment (IGA)...
- 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...
- Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination.
You likely can't join 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...
- Has a history of or current signs or symptoms of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter/minute [mL/min])...
- Currently has a or has a history of malignancy within 5 years before screening (exceptions are nonmelanoma skin cancer that has been adequately...
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and...
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, recurrent sinopulmonary infections...
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.