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A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT04060888
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Ustekinumab (approximately 6 mg/kg) Drug: Ustekinumab 90 milligram (mg) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : October 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Ustekinumab
Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.
Drug: Ustekinumab (approximately 6 mg/kg)
Participants will receive ustekinumab approximately 6 milligram per kilogram via IV route based on body weight-range.
Other Name: Stelara

Drug: Ustekinumab 90 milligram (mg)
Participants will receive 90 mg ustekinumab via SC route.
Other Name: Stelara

Placebo Comparator: Placebo
Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Drug: Placebo
Participants will receive placebo matching to ustekinumab IV or SC.




Primary Outcome Measures :
  1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 [ Time Frame: Week 52 ]
    SRI-4 is a composite of at least 4 point improvement in Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG) and no worsening in Physician's Global Assessment of Disease Activity score (PGA).


Secondary Outcome Measures :
  1. Time to Flare [ Time Frame: Baseline up to Week 52 ]
    Time to flare is the duration of flare occurring at any time after the baseline will be calculated with flare defined as either 1 or more new British Isles Lupus Assessment Group (BILAG) A or 2 or more new BILAG B domain scores relative to baseline.

  2. Percentage of Participants with an SRI-4 Composite Response at Week 24 [ Time Frame: Week 24 ]
    SLE Responder Index (SRI)-4 is a composite of at least 4 point improvement in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K, no worsening in BILAG and no worsening in PGA.

  3. Percentage of Participants Achieving at Least a 50% Improvement in the Number of Joints with Pain and Signs of Inflammation at Week 52 [ Time Frame: Week 52 ]
    The percentage of participants achieving at least a 50 percent (%) improvement in the number of joints with pain and signs of inflammation at week 52 will be reported in participants with at least 4 affected joints at baseline.

  4. Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40 and Sustain That Reduction Through Week 52 [ Time Frame: Baseline up to Week 52 ]
    Reduction of glucocorticoid dose is defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose is reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose is defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.

  5. Percentage of Participants Achieving at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52 [ Time Frame: Week 52 ]
    Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 52 will be reported in participants with a CLASI Activity Score of 4 or greater at baseline.

  6. Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40, Sustain That Reduction Through Week 52, and Achieve an SRI-4 Composite Response at Week 52 [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants receiving glucocorticoids at baseline who achieve reduction in glucocorticoid dose by Week 40, sustain that reduction through Week 52, and achieve an SRI-4 composite response at Week 52 will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Had a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent:

    1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;
    2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA)
  • Have a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith
  • Have at least 1 British Isles Lupus Assessment Group (BILAG) A and/or 2 BILAG B scores observed during screening
  • Have a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score at least 4 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation at screening, Week 0, or both
  • Have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0

Exclusion Criteria:

  • Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded
  • Has other inflammatory diseases that might confound the evaluations of efficacy (including but not limited to rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)
  • Has urinary protein level of greater than (>) 4 gram per day (g/day) or protein/creatinine ratio estimating >4g/day equivalent proteinuria
  • Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
  • Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location, clinically significant splenomegaly, or history of monoclonal gammopathy of undetermined significance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060888


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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China
The First Affiliated Hospital of Baotou Medical University Not yet recruiting
Baotou, China, 014010
Peking University First Hospital Not yet recruiting
Beijing, China, 100020
China-Japan Friendship Hospital Not yet recruiting
Beijing, China, 100029
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Peking University Third Hospital Sanyuan Hospital Suspended
Beijing, China, 100191
Peking Union Medical College Hospital Not yet recruiting
Beijing, China, 100700
The First Bethune Hospital of Jilin University Not yet recruiting
Changchun, China, 130021
China-Japan Union Hospital of Jilin University Not yet recruiting
Changchun, China, 130033
The Third Xiangya Hospital of Central Sourth University Not yet recruiting
Changshashi, China, 410013
The second Xiangya Hospital of Central South University Not yet recruiting
Changsha, China, 410011
West China Hospital, Sichuan University Not yet recruiting
Cheng'du, China, 610041
Southwest Hospital Not yet recruiting
Chongqing, China, 400038
Guangdong General Hospital Not yet recruiting
Guangzhou, China, 510080
The Second Affiliated Hospital of Zhejiang University Suspended
Hangzhou, China, 310009
First Affiliated Hospital, Harbin Medical University Suspended
Harbin, China, 150001
Anhui Province Hospital Not yet recruiting
Hefei, China, 230001
The 1st affiliated hospital of Anhui Medical University Not yet recruiting
Hefei, China, 230022
Affiliated Hospital of Inner Mongolia Med U Not yet recruiting
Hohhot, China, 10000
Qilu Hospital of Shandong University Not yet recruiting
Jinan, China, 250012
The Second Affiliated Hospital of Kunming Medical University Not yet recruiting
Kunming, China, 650101
Jiangsu Province Hospital Not yet recruiting
Nanjing, China, 210029
Jiangxi Pingxiang People's Hospital Withdrawn
Pingxiang, China, 650032
Shanghai Renji Hospital Suspended
Shanghai, China, 200001
Shanghai Renji Hospital Not yet recruiting
Shanghai, China, 200001
Shanghai Ruijin Hospital Not yet recruiting
Shanghai, China, 200025
Tianjin Medical University General Hospital Not yet recruiting
Tianjin, China, 300052
Tianjin First Center Hospital Withdrawn
Tianjin, China, 300192
Tongji Hospital of Tongji Medical College of Huangzhong Univ Not yet recruiting
Wuhan, China, 430030
Renmin Hospital of Wuhan University Not yet recruiting
Wuhan, China, 430060
First Affiliated Hospital of Xi'an Jiaotong University School of Medicine Not yet recruiting
Xi'an, China, 710061
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, China, 450052
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04060888     History of Changes
Other Study ID Numbers: CR108631
CNTO1275SLE3003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ustekinumab
Dermatologic Agents