E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Radiographic Axial Spondyloarthritis |
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E.1.1.1 | Medical condition in easily understood language |
A chronic inflammatory condition affecting the spine and sacroiliac joint. It is characterized by pain and stiffness of joints. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041672 |
E.1.2 | Term | Spondylitis ankylosing |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) vs placebo in tumor necrosis factor inhibitor (TNFi) experienced patients with active radiographic axial spondyloarthritis (r-axSpA) at Week 16. |
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E.2.2 | Secondary objectives of the trial |
To compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16 on signs and symptoms, function, mobility, and quality of life in TNFi experienced patients with r-axSpA. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
There is a MRI substudy that will be conducted in selected countries. Patients will have MRIs of the spine at screening and at Week 16. The MRI addendum version is 23Nov2015. |
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E.3 | Principal inclusion criteria |
-Are at least 18 years of age -Have an established diagnosis of radiographic axial spondyloarthritis (r-axSpA) with sacroiliitis defined radiographically according to the mNY criteria -Patients have a history of back pain ≥3 months with age at onset <45 years. -Have had prior treatment with at least 1 and not more than 2 TNF inhibitors. -Must have had an inadequate response 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. -Have given written informed consent |
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E.4 | Principal exclusion criteria |
- Have total ankylosis of the spine -Have taken none or more than two tumor necrosis factor inhibitor medications - Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year. - Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis - Have a compromised immune system. - Have any other serious and/or uncontrolled diseases. - Have either a current diagnosis or a recent history of malignant disease. - Have had Major surgery within 8 weeks of baseline, or will require surgery during the study - Are pregnant or breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-Proportion of patients achieving an ASAS20 response -Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) -Proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response -Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) -Proportion of patients achieving ASDAS inactive disease -Change from baseline in Short Form 36 (SF-36) physical component score (PCS) -Change from baseline in ASAS Health Index (ASAS HI) -Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score). (This endpoint applies to MRI addendum only). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Canada |
Israel |
Korea, Republic of |
Mexico |
Puerto Rico |
United States |
Finland |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Spain |
United Kingdom |
Argentina |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |