A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2014-005000-19-ES
• Date of registration: 03/03/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
• Date of first enrolment: 11/05/2015
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005000-19
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Germany, Hungary, Mexico, Poland, Spain, Taiwan, United States

Contacts

• Name: Global Clinical Operations
• Affiliation: Janssen-Cilag S.A.

• Name: Global Clinical Operations
• Affiliation: Janssen-Cilag S.A.

Key inclusion & exclusion criteria

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 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, test for
autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies
- At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening
- At least 1 BILAG A and/or 2 BILAG B domain scores observed at screening and/or at Week 0 prior to first administration of study agent
- Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization (Week 0).
- Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory-based items) 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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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 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 immunosuppressives other than those described in inclusion criteria within the past 6 months prior to first administration of study agent
- Have 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 B-cell depletion following such therapy
- Have ever received ustekinumab


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus
MedDRA version: 17.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 24

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

Main Objective: To evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active SLE

Primary end point(s): Percentage of Participants With a Composite SRI-4 Response at Week 24

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 24

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

Secondary ID(s)

CNTO1275SLE2001

2014-005000-19-HU

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date:
Contact: