NCT04914429.

Study name	A study of guselkumab (TREMFYA) in Chinese participants with moderate‐to‐severe plaque psoriasis
Methods	RCT, placebo‐controlled, double‐blind study Date of study: August 2021 Location: China (28 sites) Phase 4
Participants	Randomised: 300 participants Inclusion criteria Have a diagnosis of plaque psoriasis with or without psoriatic arthritis for at least 6 months before screening A woman of childbearing potential must have a negative urine pregnancy test at screening and at baseline 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 Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet (UV) light sources during study 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 non‐plaque form of psoriasis (example, erythrodermic, guttate, or pustular) Has a history of or current signs or symptoms of liver or renal insufficiency (estimated creatinine clearance below 60 millilitre/minute (mL/min)); significant, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances Currently has a history of malignancy within 5 years before screening (exceptions are non‐melanoma 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) History of, or ongoing, chronic or recurrent infectious disease, including but not limited to, recurrent sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infection (for example, recurrent pyelonephritis, recurrent cystitis), fungal infection (mucocutaneous candidiasis), an open, draining, or infected skin wound, or an ulcer Has previously received guselkumab
Interventions	Intervention A. Guselkumab 100 mg SC injection at weeks 0, 4, and then every 8 weeks (Q8W) Control intervention B. Placebo
Outcomes	At week 16 Primary outcomes PASI 90 IGA AEs up to week 56 SAEs up to week 56 AEs leading to discontinuation of study intervention up to week 56 Participants with infections up to week 56 Participants with serious hypersensitivity reactions up to week 56 Participants with injection‐site reactions up to week 56 Change from baseline in laboratory abnormalities up to week 56 Laboratory abnormalities with maximum toxicity grades up to week 56 Change from baseline in vital signs up to week 56 Secondary outcomes PASI 100, PASI 90, PASI 75, and PASI 50 at week 0, 4, 12, 16, 20, 28, 36, 44, 48 IGA at week 0, 4, 12, 16, 20, 28, 36, 44, 48 DLQI at week 0, 4, 12, 16, 20, 28, 36, 44, 48 Percentage of participants who maintain PASI 90 response at week 48 among participants who were PASI 90 responders at week 16 in guselkumab group at week 48 Percentage of participants who maintain IGA score of cleared (0) or minimal (1) at week 48 among participants who achieved IGA 0/1 at week 16 in guselkumab group at week 48 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) over time at week 0, 4, 12, 16, 20, 28, 36, 44, 48 Percentage of participants who achieve a DLQI score of 0 or 1 over time among participants with baseline DLQI greater than (>) 1 at week 0, 4, 16, 28, 48 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 a ss‐IGA Score ≥ 2 at baseline at week 0, 16, 28, 36, 48 Serum concentration of guselkumab over time at week 0, 4, 16, 20, 36, 44, 56 Number of participants with antibodies to guselkumab at week 0, 16, 44, 56
Starting date	Study start date: August 2021 Estimated study completion date: December 2023 Last update posted: October 2022, recruiting
Contact information	Study contact: 844‐434‐4210, JNJ.CT@sylogent.com Investigators Study Director: Janssen Research & Development, LLC Clinical Trial
Notes	Funding: Janssen Research & Development, LLC Last check in October 2022