A Study of Guselkumab in Participants With Active Lupus Nephritis (ORCHID-LN)

March 28, 2025 updated by: Janssen Research & Development, LLC

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Guselkumab is a monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of plaque psoriasis, psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. Lupus is a heterogeneous autoimmune disease with lesions confined to skin (cutaneous lupus erythematosus [CLE]) to others that involve 1 or more vital internal organs (systemic lupus erythematosus [SLE]). Renal involvement due to SLE is termed lupus nephritis (LN). There is a high unmet need for new treatment options in LN that are safe and effective, especially new therapies that can provide improved long-term efficacy over currently available therapies. This study will evaluate safety and efficacy of guselkumab added to standard-of-care compared to placebo added to standard-of-care. Total duration of study is up to 68 weeks: a less than or equal to 8 week screening period, a 48 week double-blind treatment period, a 12 week safety follow-up period after last dose. Participants who complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) of study through Week 152 and the 12-week safety follow-up visit. Hypothesis of this study is that guselkumab plus standard-of-care is superior to placebo plus standard-of-care in participants with active LN as measured by the proportion of participants inducing at least a 50 percentage reduction of proteinuria with protocol specified steroid tapering regimen at Week 24. Safety assessments include Adverse events (AEs), clinical laboratory tests (hematology and chemistry), systolic and diastolic blood pressures over time, monitoring for hypersensitivity reactions, AEs temporally associated with infusion, injection-site reactions, suicidality assessment, and early detection of active tuberculosis (TB).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Centro Médico Reumatológico (OMI)
      • Caba, Argentina, 1221
        • Hospital Ramos Mejía
      • Caba, Argentina, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • Cordoba, Argentina, 05000
        • Instituto Medico Strusberg SA
      • Córdoba, Argentina, X5016LIG
        • Clínica Privada Vélez Sarsfield
      • Mendoza, Argentina, 5000
        • Instituto de Reumatologia - Ir Medical Center S.A.
      • Rosario, Argentina, S2000DEJ
        • Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
      • San Miguel De Tucuman, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • Mexico
      • Ciudad de Mexico, Mexico, 11850
        • Centro de Investigacion y Tratamiento Reumatologico S C
      • Guadalajara, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Merida, Mexico, 97000
        • Unidad Reumatologica las Americas S.C.P.
      • Mexico, Mexico, 07760
        • Consultorio de Reumatologia
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • San Luis Potosi, Mexico, 78290
        • Unidad de Investigaciones Reumatológicas A.C
  • Poland
      • Gdansk, Poland, 80 952
        • Uniwersyteckie Centrum Medyczne Klinika Nefrologii Transplantologii i Chorob Wewnetrznych
      • Lodz, Poland, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
      • Wroclaw, Poland, 50 556
        • Uniwersytecki Szpital Kliniczny we Wroclawiu
  • Russian Federation
      • Kemerovo, Russian Federation, 650070
        • LLL Medical Center Revma-Med
      • Orenburg, Russian Federation, 460000
        • Orenburg State Medical University
      • Saint-Petersburg, Russian Federation, 196066
        • LLC Medical Sanitary Part No. 157
      • Saratov, Russian Federation, 410053
        • Saratov Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 196070
        • LLC German Clinic
  • Spain
      • A Coruna, Spain, 15006
        • Hosp Univ A Coruna
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Bilbao, Spain, 48013
        • Hosp. Univ. de Basurto
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, Spain, 28942
        • Hosp. Univ. Fuenlabrada
      • Valencia, Spain, 46010
        • Hosp. Clinico Univ. de Valencia
  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital and Medical College
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiangmai Hospital
      • Hat Yai, Thailand, 90110
        • Songklanagarind Hospital
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
      • Kharkiv, Ukraine, 61058
        • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
      • Kryvyi Rih, Ukraine, 50056
        • City Clinical Hospital No. 2
      • Kyiv, Ukraine, 02000
        • Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ukraine, 03680
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Kyiv, Ukraine, 04050
        • Medical Center 'Consylium Medical'
      • Kyiv, Ukraine, 04050
        • State Institution 'Institute of Nephrology of the National Academy of Medical Sciences of Ukraine'
      • Odessa, Ukraine, 65025
        • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
      • Odessa, Ukraine, 65026
        • Multidisciplinary Medical Center of Odessa National Medical University
      • Ternopil, Ukraine, 46002
        • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
      • Vinnytsia, Ukraine, 21018
        • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
      • Vinnytsya, Ukraine, 21009
        • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
      • Zaporizhzhya, Ukraine, 69600
        • Medical Center LLC 'Modern Clinic'
  • United States
    • California
      • Covina, California, United States, 91722
        • Medvin Clinical Research
      • La Jolla, California, United States, 92037
        • UC San Diego
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
    • New York
      • Brooklyn, New York, United States, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • Manhasset, New York, United States, 11030
        • The Feinstein Institute for Medical Research
    • Texas
      • El Paso, Texas, United States, 79902
        • Med Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At screening and randomization, must be receiving oral glucocorticoids at minimum prednisone equivalent dose of 10 milligrams per day (mg/day) and maximum 1 mg/kg/day or less than or equal to (<=) 60 mg/day, whichever is lower. Treated for greater than or equal to (>=) 6 weeks with stable dosing >=2 weeks before randomization
  • If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to randomization
  • Positive antinuclear antibody (ANA; >= 1:80 titer by central laboratory test) or anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies (>=30 international units per milliliter ([U/mL] by central laboratory test) detected at screening
  • Kidney biopsy documentation of active International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV (with or without class V membranous nephritis) within the last 6 months prior to screening or performed during screening
  • Urine Protein to Creatinine Ratio (UPCR) >= 1.0 milligram/milligram (mg/mg) assessed on 2 first morning urine void specimens during screening. These 2 specimens do not need to be on consecutive days, however, 2 samples must be tested with UPCR >= 1.0 mg/mg in a row. The UPCR requirement must be met after at least 8 weeks of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) treatment, and after stable glucocorticoid dosing is achieved at the dose intended at time of randomization

Exclusion Criteria:

  • Comorbidities (other than lupus nephritis [LN], example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
  • Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
  • Received PO (orally) or intravenously (IV) cyclophosphamide within 3 months prior to randomization
  • History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
  • History of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Guselkumab+Standard of Care
Participants will receive guselkumab Dose 1 intravenously (IV) at Weeks 0, 4 and 8 and guselkumab Dose 2 subcutaneous (SC) every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the long-term extension (LTE).
Drug: Guselkumab Dose 1
Participants will receive guselkumab Dose 1 via IV administration.
Other Names:
  • CNTO 1959
Drug: Guselkumab Dose 2
Participants will receive guselkumab Dose 2 via SC route.
Other Names:
  • CNTO1959
Drug: Standard-of-care treatment
Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
Placebo Comparator: Placebo+Standard of Care
Participants will receive placebo IV at Weeks 0, 4 and 8 and placebo SC q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the LTE of the study.
Drug: Standard-of-care treatment
Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
Drug: Placebo
Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24
Time Frame: Week 24
Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 was reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24
Time Frame: Week 24
Percentage of participants who achieved CRR at Week 24 were reported. CRR was defined as UPCR less than (<) 0.5 milligrams per milligrams (mg/mg), estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) or no confirmed decrease >=20% from baseline and prednisone dose less than or equal to (<=) 10 milligrams per day (mg/d). Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure (OM) time point (Week 24) or initiation of prohibited medications at any time prior to the endpoint time point (Week 24).
Week 24
Percentage of Participants Who Achieved CRR at Week 52
Time Frame: Week 52
Percentage of participants who achieved CRR at Week 52 were reported. CRR was defined as UPCR less than (<) 0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease >=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).
Week 52
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24
Time Frame: From Week 16 through Week 24
Percentage of participants achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent from week 16 through Week 24were reported.
From Week 16 through Week 24
Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52
Time Frame: Week 52
Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 52 were reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.
Week 52
Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24
Time Frame: Week 24
Percentage of participants with UPCR <0.5 mg/mg at Week 24 were reported.
Week 24
Percentage of Participants With UPCR < 0.75 mg/mg at Week 24
Time Frame: Week 24
Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.
Week 24
Percentage of Participants Who Achieved CRR Through Week 24
Time Frame: Up to Week 24
Percentage of participants who achieved CRR through Week 24 was reported. CRR was defined as UPCR<0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease>=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to lupus nephritis (LN) or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 24) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 24).
Up to Week 24
Percentage of Participants With Treatment Failure (TF) Through Week 52
Time Frame: Up to Week 52
Percentage of participants with TF through Week 52 was reported. TF was defined as time to the first occurrence of TF from baseline. Participant was considered to have treatment failure, who did not continue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).
Up to Week 52
Number of Participants With Adverse Events (AEs)
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants with SAEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Related AEs
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with related AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Related AE was defined as the AE assessed by the investigator related to study agent.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with AEs leading to discontinuation of study intervention were reported.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Infections
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with infections as assessed by the investigator were reported.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Serious Infections
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with serious infections as assessed by the investigator were reported.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Infections Requiring Oral or Parenteral Antimicrobial Treatment
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With AEs Temporally Associated With an Infusion
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with AEs temporally (a reaction that occurred during or within 1 hour after infusion) associated with an infusion were reported. AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With AEs With Injection-site Reactions
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with injection-site reactions as assessed by the investigator were reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Basophils
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: basophils was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Eosinophils
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: eosinophils was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: erythrocytes was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Hematocrit
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical Laboratory parameter: hematocrit was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Hemoglobin
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: hemoglobin was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter Leukocytes
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: leukocytes was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Lymphocytes
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: lymphocytes was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Monocytes
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: monocytes was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Platelets
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: platelets was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: prothrombin time was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Albumin
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: albumin was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Bicarbonate
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: bicarbonate was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Bilirubin
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: bilirubin was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Calcium
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: calcium was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Chloride
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: chloride was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Cholesterol
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: cholesterol was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: creatine kinase was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Creatinine
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: creatinine was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Protein
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: protein was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Phosphate
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: phosphate was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Sodium
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: sodium was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Potassium
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: potassium was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen
Time Frame: Baseline (Week 0), Week 24, and Week 52
Change from baseline in clinical laboratory parameter: urea nitrogen was reported.
Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Time Frame: Baseline (Week 0), Weeks 24 and 52
Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported.
Baseline (Week 0), Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase
Time Frame: Baseline (Week 0), Weeks 24 and 52
Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported.
Baseline (Week 0), Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium
Time Frame: Baseline, Weeks 24, 52
Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.
Baseline, Weeks 24, 52
Change From Baseline in Clinical Laboratory Parameter: Protein
Time Frame: Baseline (Week 0), Weeks 24 and 52
Change from baseline in clinical laboratory parameter: protein was reported.
Baseline (Week 0), Weeks 24 and 52
Change From Baseline in Chemistry Parameters: Protein/Creatinine
Time Frame: Baseline, Weeks 24 and 52
Change from baseline in chemistry parameter: protein/creatinine was reported.
Baseline, Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Urate
Time Frame: Baseline, Weeks 24, 52
Change from baseline in clinical laboratory parameter: urate was reported.
Baseline, Weeks 24, 52
Change From Baseline in Clinical Laboratory Parameter: Urine Protein
Time Frame: Baseline (Week 0), Weeks 24 and 52
Change from baseline in clinical laboratory parameter: urine protein was reported.
Baseline (Week 0), Weeks 24 and 52
Number of Participants With Maximum US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Toxicity Grade (Grade 4) in Clinical Laboratory Parameters: Hematology and Chemistry
Time Frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of participants with maximum US NCI-CTCAE toxicity grade (Grade 4) in clinical laboratory parameters: hematology and chemistry were reported. Toxicity were graded as Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.
DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure
Time Frame: Up to Week 60
Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported.
Up to Week 60
Serum Concentration of Guselkumab
Time Frame: Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Week 0 (1 hour after intravenous administration), Day 2, Week 52 and 60
Serum Concentration of guselkumab were reported.
Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Week 0 (1 hour after intravenous administration), Day 2, Week 52 and 60
Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response
Time Frame: From Baseline (Week 0) through Week 24 and Week 60
Treatment-boosted ADA positive participants: participants who were positive at baseline and whose titers increased 2-fold at any time after treatment. Titer values were categorized as<=1:10, 10 to 100, 100 to 1000, >1000.
From Baseline (Week 0) through Week 24 and Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108766
  • 2018-003155-38 (EudraCT Number)
  • CNTO1959LUN2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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