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

NCT04914429 | Completed Phase 4

• 2 other identifiers: CR109025CNTO1959PSO4009
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 26

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

  The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (\>=)90 percent (%) improvement in PASI score.

  Week 16

• Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

  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).

  Week 16

• Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.

  Up to Week 56

• Number of Participants with Serious Adverse Events (SAEs)

  SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

  Up to Week 56

• Number of Participants with Reasonably Related Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.

  Up to Week 56

• Number of Participants with AEs Leading to Discontinuation of Study Intervention

  Number of participants with AEs leading to discontinuation of study intervention will be reported.

  Up to Week 56

• Number of Participants with Infections

  Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported.

  Up to Week 56

• Number of Participants with Serious Hypersensitivity Reactions

  Number of participants with serious hypersensitivity reactions (such as anaphylaxis, urticaria, pruritis, angioedema, wheezing, dyspnea, or hypotension) will be reported.

  Up to Week 56

• Number of Participants with Injection-site Reactions

  An injection-site reaction is any unfavorable or unintended sign 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.

  Up to Week 56

• 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.

  Up to Week 56

• Number of Participants with Laboratory Abnormalities with Maximum Toxicity Grades

  Number of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades will be reported. A higher grade indicates more severity.

  Up to Week 56

• 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.

  Up to Week 56

Secondary Outcomes (14)

• Percentage of Participants who Achieve a PASI 100, PASI 75, and PASI 50 Response Over Time

  Week 0, 4, 12, 16, 20, 28, 36, 44, 48

• Percentage of Participants who Achieve a PASI 90 Response Over Time

  Week 0, 4, 12, 16, 20, 28, 36, 44, 48

• Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time

  Week 0, 4, 12, 16, 20, 28, 36, 44, 48

• Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time

  Baseline, Week 4, 16, 28, 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

  Week 48

Study Arms (2)

Group 1: Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab; Drug: Placebo

Group 2: Placebo

PLACEBO COMPARATOR

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.

Drug: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

Guselkumab 100 mg will be administered as a SC injection.

Also known as: TREMFYA

Group 1: Guselkumab; Group 2: Placebo

Placebo DRUG

Matching placebo will be administered as a SC injection.

Group 1: Guselkumab; Group 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (26)

Peking University Third Hospital

Beijing, 100191, China

Location

Beijing Tongren Hospital, CMU

Beijing, 100730, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

The second Xiangya Hospital of Central South University

Changsha, 410011, China

Location

West China Hospital,Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

The First Hospital Affiliated to AMU (Southwest Hospital)

Chongqing, 400038, China

Location

Fujian Medical University

Fuzhou, 350005, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, 510091, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, 310004, China

Location

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, 310009, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

The 1st affiliated hospital of Anhui Medical University

Hefei, 230022, China

Location

Skin Disease Hospital of Shandong Province

Jinan, 250022, China

Location

Jiangsu Province Hospital

Nanjing, 210029, China

Location

Hospital of Dermatology, Chinese Academy of Medical Science

Nanjing, 210042, China

Location

Shanghai Ruijin Hospital

Shanghai, 200025, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Shanghai skin disease hospital

Shanghai, 200050, China

Location

University of Hong Kong-Shenzhen Hospital

Shenzhen, 518053, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, 300120, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

Location

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

Wuhan, 430022, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

Location

Henan province people's hospital

Zhengzhou, 450003, China

Location

Related Publications (1)

• Huang K, Geng S, Tao X, Sun L, Ji C, Yang B, Lu Y, Xiao R, Zhang C, Zhang F, Lu Q, Zheng J, Wang H, Shi Y, Li Z, Yan W, Zhang L, Tao J, Zhang S, Yang X, Cheng H, Xu J, Su J, Zhang Z, Song Z, Wang L, Wang R, Zhang T, Zhao W, Huang Y, Chen M, Dong Z, Lyu S, Zheng M. Efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled trial. Chin Med J (Engl). 2025 Sep 8. doi: 10.1097/CM9.0000000000003771. Online ahead of print.

  PMID: 40921728 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 4, 2021
• Study Start: August 25, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (26)