A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Study Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in the treatment of Chinese participants with moderate to severe plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 nonplaque 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 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 year 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) - 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), an open, draining, or infected skin wound, or an ulcer.
- Has previously received guselkumab

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04914429
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Group 1: Guselkumab

Participants will receive guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, and then every 8 weeks (q8w) through Week 44. Participants will receive matching placebo at Week 16.

Placebo Comparator: Group 2: Placebo

Participants will receive placebo SC injection for guselkumab at Weeks 0, 4, and 12, and then cross over at Week 16 to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and q8w thereafter through Week 44.

Interventions

Drug: - Guselkumab

Guselkumab 100 mg will be administered as a SC injection.

Drug: - Placebo

Matching placebo will be administered as a SC injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, China

Status

Recruiting

Address

Dermatology Hospital of Southern Medical University

Guangzhou, , 510091

Hangzhou, China

Status

Not yet recruiting

Address

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, , 310009

Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, , 300052

Tianjin, China

Status

Not yet recruiting

Address

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, , 300120

Wuhan, China

Status

Not yet recruiting

Address

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, , 430022

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