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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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12 November 2018 |
Main ID: |
EUCTR2014-005000-19-DE |
Date of registration:
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12/02/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
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Scientific title:
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus |
Date of first enrolment:
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17/06/2015 |
Target sample size:
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134 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005000-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Germany
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Hungary
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Mexico
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Poland
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Spain
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Taiwan
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United States
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Contacts
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31 71 5242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31 71 5242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months prior to first dose
- At least 1 welldocumented (subject file, referring physician letter, or laboratory result), unequivocally positive, documented test for auto antibodies in medical history including either of the following: ANA,and/or antidsDNA antibodies, and/or antiSmith antibodies
- At least 1 unequivocally positive autoantibody test including ANA and/or antidsDNA antibodies and/or antiSmith antibodies detected during screening
- At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to first administration of study agent Demonstrate active disease based on SLEDAI2K score greater than or equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization. Must also have SLEDAI2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory results) at Week 0 prior to the first administration of study agent
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria: - Have 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 or active Lyme disease
- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
- Have received systemic or topical cream/ointment preparations of cyclosporine A or other systemic immunomodulatory agents other than those described in inclusion criteria within the past 3 months prior to first administration of study agent
- Have received a single B cell targeting agent within 3 months prior to first study agent administration; or received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued Bcell depletion following such therapy
- Have ever received ustekinumab
- Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin that has been treated with no evidence of recurrence for at least 3 months before the first study agent administration and carcinoma in situ of the cervix that has been surgically cured)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Systemic Lupus Erythematosus MedDRA version: 18.1
Level: PT
Classification code 10042945
Term: Systemic lupus erythematosus
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Intervention(s)
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Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active SLE
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Primary end point(s): Percentage of Participants With a Composite SRI-4 Response at Week 24
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Secondary Objective: To evaluate: • The safety and tolerability of ustekinumab in subjects with SLE. • The effect of ustekinumab administration on health-related quality of life in subjects with SLE. • The effects of ustekinumab on cutaneous manifestations of SLE. • Pharmacokinetics and immunogenicity of ustekinumab in subjects with SLE
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary Outcome(s)
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Secondary end point(s): - Change From Baseline in SLEDAI-2K Score at Week 24.
- Change From Baseline in Physician Global Assessment of Disease Activity (PGA) at Week 24
- Percentage of Participants With BICLA Response at Week 24
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary ID(s)
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2014-005000-19-HU
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CNTO1275SLE2001
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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