A 52 Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2015-003938-27-FI
• Date of registration: 26/02/2016
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A 52 Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis
• Scientific title: A 52 Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis
• Date of first enrolment: 20/04/2016
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003938-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; 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, Austria, Brazil, Canada, Czech Republic, Finland, Germany, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
Presence of sacroiliitis on MRI (according to ASAS/OMERACT criteria and based on central reading) (Rudwaleit et al. 2009d) and have at least 1 SpA feature
OR
Are positive for HLA-B27 and have at least 2 additional SpA features, according to the ASAS criteria (Sieper et al. 2009; Rudwaleit et al. 2009a) SpA features listed in Appendix 5

Patients have a history of back pain =3 months with age at onset <45 years.

Have active nonrad-axSpA defined as BASDAI =4 and total back pain =4 on a NRS at screening and baseline (Sieper et al. 2009)

Patients have objective signs of inflammation by presence of sacroiliitis on MRI (as defined by ASAS/OMERACT) or presence of elevated CRP (defined as CRP >5.00 mg/L).

Must have had an inadequate response, as determined by the investigator, to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs

Patients must have a history of prior therapy for axSpA of at least 12 weeks prior to screening. Examples of prior therapy may include but are not limited to physical therapy and NSAID treatment.


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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion criteria:
Fulfillment of the modified New York (mNY) criteria (van der Linden et al. 1984) with sacroiliitis defined radiographically, based on central reading: sacroiliitis grade =2 bilaterally or grades 3 to 4 unilaterally

Have a history of other systemic inflammatory diseases that might confound the evaluations of benefit from ixekizumab therapy (such as, but not limited to, lupus, vasculitis, or RA), or other chronic pain conditions (such as but not limited to fibromyalgia)
Note: Patients with psoriasis who do not require systemic treatment, such as, but not limited to, oral agents or biologic therapies, can be included provided these patients fulfill the study entry criteria.

Have active Crohn’s disease (CD) or active ulcerative colitis (UC)
Note: Patients may be enrolled if they have had a history of inflammatory bowel disease (IBD), including CD and UC, but have had no exacerbation for =6 months prior to baseline, and, if currently on treatment, must be on stable treatment for =6 months prior to baseline.

Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization



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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859

Intervention(s)

Product Name: ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Solution for infusion in pre-filled syringe
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 16 (for regulatory agencies that require Week 16 as the primary endpoint)

Week 52 (for regulatory agencies that require week 52 as the primary endpoint)

Secondary Objective: To compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W versus placebo in patients with active nonrad-axSpA at Week 16 and Week 52

Main Objective: Compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active nonradiographic axial spondyloarthritis (nonrad-axSpA)

Primary end point(s): Proportion of patients achieving an ASAS40

Secondary Outcome(s)

Secondary end point(s): • Change from baseline in (ASDAS) at Week 16
• Change from baseline in ASDAS at Week 52
• Change from baseline in (BASFI) at Week 16
• Change from baseline in BASFI at Week 52
• Proportion of patients achieving ASDAS inactive disease at Week 16
• Proportion of patients achieving ASDAS inactive disease at Week 52
• Change from baseline in MRI of the (SIJ) [SPARCC] score) at Week 16
• Percent of patients without clinically meaningful changes in background therapy at Week 52

Timepoint(s) of evaluation of this end point: Weeks 16 and 52 depending on the end points. See above.

Secondary ID(s)

2015-003938-27-DE

I1F-MC-RHBX

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date:
Contact: