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PsoriasisPhase 4NCT04914429

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

A Phase 4 study testing Guselkumab in people with Psoriasis, run by Janssen Research & Development, LLC at 26 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
327 participants
Where
26 sitesChina
Study dates
25 Aug 2021to 26 Sep 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

26 sites in 1 country.

26 sites in 1 country

China26 sites

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Tongren Hospital, CMU

    Beijing, 100730

  • Xiangya Hospital Central South University

    Changsha, 410008

  • The second Xiangya Hospital of Central South University

    Changsha, 410011

  • West China Hospital,Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • The First Hospital Affiliated to AMU (Southwest Hospital)

    Chongqing, 400038

  • Fujian Medical University

    Fuzhou, 350005

  • Dermatology Hospital of Southern Medical University

    Guangzhou, 510091

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310004

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016

  • The 1st affiliated hospital of Anhui Medical University

    Hefei, 230022

  • Skin Disease Hospital of Shandong Province

    Jinan, 250022

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Hospital of Dermatology, Chinese Academy of Medical Science

    Nanjing, 210042

  • Shanghai Ruijin Hospital

    Shanghai, 200025

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Shanghai skin disease hospital

    Shanghai, 200050

  • University of Hong Kong-Shenzhen Hospital

    Shenzhen, 518053

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, 300120

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

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

    Wuhan, 430022

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

  • Henan province people's hospital

    Zhengzhou, 450003

Other trials in China

About this study

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

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
Being tested
Guselkumab, Placebo
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    Also called TREMFYA

    Guselkumab 100 mg will be administered as a SC injection.

  • PlaceboDrug

    Matching placebo will be administered as a SC injection.

Study groups in NCT04914429
Study groupRoleWhat they receive
Group 1: GuselkumabExperimentalParticipants 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.
Receives: Drug: Guselkumab; Drug: Placebo
Group 2: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Guselkumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 16

  2. 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).

    Measured: Week 16

  3. 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.

    Measured: Up to Week 56

  4. 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.

    Measured: Up to Week 56

  5. 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.

    Measured: Up to Week 56

  6. 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.

    Measured: Up to Week 56

  7. Number of Participants with Infections

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

    Measured: Up to Week 56

  8. 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.

    Measured: Up to Week 56

  9. 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.

    Measured: Up to Week 56

  10. 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.

    Measured: Up to Week 56

  11. 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.

    Measured: Up to Week 56

  12. 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.

    Measured: Up to Week 56

Secondary outcomes (14)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: Baseline, Week 4, 16, 28, 48

  5. 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.

    Measured: Week 48

  6. 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.

    Measured: Week 48

  7. 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.

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

  8. 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.

    Measured: Week 0, 4, 16, 28, 48

  9. 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.

    Measured: Week 0, 4, 16, 28, 48

  10. 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).

    Measured: Baseline, Week 16, 28, 36, 48

  11. 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).

    Measured: Week 0, 16, 28, 36, 48

  12. Serum Concentration of Guselkumab Over Time

    Serum concentrations of guselkumab over time will be reported.

    Measured: Week 0, 4, 16, 20, 36, 44, 56

  13. Number of Participants with Antibodies to Guselkumab

    Number of participants with antibodies to guselkumab through week 56 will be reported.

    Measured: Week 0, 16, 44, 56

  14. Maximum Titer of Antibodies to Guselkumab Through Week 56

    Maximum titer of antibodies to guselkumab through Week 56 will be reported.

    Measured: Week 0, 16, 44, 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start25 Aug 2021
  3. Primary completion26 Sep 2023
  4. Study completion26 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914429
Sponsor's protocol ID
CR109025
Other IDs
CNTO1959PSO4009
Status last verified
Oct 2023
First submitted
3 Jun 2021
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • 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.

    PubMed 40921728

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Guselkumab in people with Psoriasis, run by Janssen Research & Development, LLC at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (time frame: Week 16). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04914429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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