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 | 19.0 |
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 patients with active radiographic axial spondyloarthritis 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 radiographic axial spondyloarthritis patients that are bDMARD Naïve. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Are ambulatory and at least 18 years of age
Diagnosis of radiographic axial spondyloarthritis (raxSpA) with sacroiliitis defined radiographically according to the mNY criteria
Patients have a history of back pain ≥3 months with age at onset <45 years.
In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS
If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization
Have given written informed consent
Have a history of prior therapy for axSpa for at least 12 weeks prior to screening
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E.4 | Principal exclusion criteria |
Have total ankylosis of the spine
Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents
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 magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score)
Change from baseline in Short Form 36 (SF-36) physical component score (PCS)
Change from baseline in ASAS Health Index (ASAS-HI)
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 |
Canada |
Czech Republic |
Germany |
Hungary |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Poland |
Russian Federation |
Taiwan |
United States |
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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 |