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

Psoriasis Clinical Trial

Official title:

A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914429
• Other study ID #: CR109025
• Secondary ID: CNTO1959PSO4009
• Status: Completed
• Phase: Phase 4
• Start date: August 25, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: October 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Guselkumab
Guselkumab 100 mg will be administered as a SC injection.
• Placebo
Matching placebo will be administered as a SC injection.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, CMU	Beijing
China	Peking University Third Hospital	Beijing
China	The second Xiangya Hospital of Central South University	Changsha
China	Xiangya Hospital Central South University	Changsha
China	West China Hospital,Sichuan University	Chengdu
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The First Hospital Affiliated to AMU (Southwest Hospital)	Chongqing
China	Fujian Medical University	Fuzhou
China	Dermatology Hospital of Southern Medical University	Guangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	The Second Affiliated Hospital of Zhejiang University College of Medicine	Hangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	The 1st affiliated hospital of Anhui Medical University	Hefei
China	Skin Disease Hospital of Shandong Province	Jinan
China	Hospital of Dermatology, Chinese Academy of Medical Science	Nanjing
China	Jiangsu Province Hospital	Nanjing
China	Huashan Hospital Fudan University	Shanghai
China	Shanghai Ruijin Hospital	Shanghai
China	Shanghai skin disease hospital	Shanghai
China	University of Hong Kong-Shenzhen Hospital	Shenzhen
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Union Hospital Tongji Medical College of Huazhong University of Science and Technology	Wuhan
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	Henan province people's hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of Participants who Achieve a PASI 100, PASI 75, and PASI 50 Response Over Time	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. The PASI produces a numeric score that can range from 0 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.	Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Secondary	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 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 >=90% improvement in PASI score.	Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Secondary	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.	Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Secondary	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.	Baseline, Week 4, 16, 28, 48
Secondary	Percentage of Participants who Maintain PASI 90 Response at Week 48 Among Participants who were PASI 90 Responders at Week 16 in Guselkumab Group	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 >=90% improvement in PASI score.	Week 48
Secondary	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	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 will be reported.	Week 48
Secondary	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	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.	Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Secondary	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.	Week 0, 4, 16, 28, 48
Secondary	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.	Week 0, 4, 16, 28, 48
Secondary	Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) 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).	Baseline, Week 16, 28, 36, 48
Secondary	Percentage of Participants with an 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).	Week 0, 16, 28, 36, 48
Secondary	Serum Concentration of Guselkumab Over Time	Serum concentrations of guselkumab over time will be reported.	Week 0, 4, 16, 20, 36, 44, 56
Secondary	Number of Participants with Antibodies to Guselkumab	Number of participants with antibodies to guselkumab through week 56 will be reported.	Week 0, 16, 44, 56
Secondary	Maximum Titer of Antibodies to Guselkumab Through Week 56	Maximum titer of antibodies to guselkumab through Week 56 will be reported.	Week 0, 16, 44, 56