A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2015-000289-67-HU
• Date of registration: 12/06/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
• Scientific title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
• Date of first enrolment: 11/08/2015
• Target sample size: 390
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000289-67
• 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: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Czech Republic, France, Germany, Hungary, Korea, Republic of, Mexico, Poland, Russian Federation, Taiwan, Ukraine, United Kingdom

Contacts

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
- Must have an age at nr-AxSpA onset of <= 45 years
- Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
- Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (>=) 4, each on a scale of 0 to 10
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 390
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
- Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
- Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
- Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
- Have received prior biologic therapy other than anti-TNFa
- Have received more than 1 prior anti-TNFa agent


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

Health Condition(s) or Problem(s) studied

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

Nonradiographic Axial Spondylitis, Ankylosing
MedDRA version: 19.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859

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 milligram(s)
Concentration type: equal
Concentration number: 45-
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 in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Concentration unit: mg milligram(s)
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

Primary Outcome(s)

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

Main Objective: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

Primary end point(s): Percentage of Participants Achieving Assessment of SpondyloArthritis International
Society (ASAS) 20 Score at Week 24.

Secondary Objective: Secondary Objectives:
-Efficacy related to improving physical function, range of motion, health-related quality of life, and other health outcomes.
-Safety.
-Pharmacokinetics (PK) and immunogenicity.
-Time to flare after randomized withdrawal.

Secondary Outcome(s)

Secondary end point(s): -Percentage of Participants Achieving ASAS 40 at Weeks 24.
-Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) 50 Response.
-Percentage of Participant Who Achieve ASDAS (CRP) Inactive Disease (<1.3) at Week 24.

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

Secondary ID(s)

CNTO1275AKS3003

2015-000289-67-BE

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 27/07/2015
Contact:

Results

• Results available: Yes
• Date Posted: 12/10/2018
• Date Completed: 26/09/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000289-67/results