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

Phase 1

Conditions: bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis
MedDRA version: 19.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2015-003938-27-NL

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 302

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) at Week 16;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;Primary end point(s): Proportion of patients achieving an ASAS40 ;Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Proportion of patients achieving an ASAS40 response at Week 52<br>•Change from baseline in (ASDAS) at Week 16<br>•Change from baseline in ASDAS at Week 52<br>•Change from baseline in (BASFI) at Week 16<br>•Change from baseline in BASFI at Week 52 <br>•Proportion of patients achieving ASDAS inactive disease at Week 16<br>•Proportion of patients achieving ASDAS inactive disease at Week 52<br>•Change from baseline in MRI of the (SIJ) [SPARCC] score) at Week 16<br>•Percent of patients without clinically meaningful changes in background therapy at Week 52<br>;Timepoint(s) of evaluation of this end point: Weeks 16 and 52 depending on the end points. See above.

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