E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Inflammatory disease 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 |
To evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal period |
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E.2.2 | Secondary objectives of the trial |
-To compare the combined ixekizumab treatment group to historical control for 2-year radiographic progression in spine in patients with active radiographic axSpA
-To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg every 2 weeks (Q2W) treatment group or ixekizumab 80 mg every 4 weeks (Q4W) treatment group is superior to placebo in maintaining response
-To evaluate in patients having achieved a state of sustained remission whether the combined ixekizumab treatment group is superior to the placebo group in maintaining response after treatment withdrawal
-To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg Q2W treatment group or ixekizumab 80 mg Q4W treatment group is superior to placebo in maintaining response after treatment withdrawal |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Have completed the final study visit in Study RHBV, RHBW, or RHBX. (Note: Patients from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a TNF inhibitor).
2.Must agree to use a reliable method of birth control.
3.Have given written informed consent. |
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E.4 | Principal exclusion criteria |
-Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous ixekizumab study that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered.
-Have a known hypersensitivity to ixekizumab or any component of this investigational product.
-Had investigational product permanently discontinued during a previous ixekizumab study.
-Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the patient’s participation in the study.
-Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
-Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal retreatment period |
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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) |
-Change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS score)
-The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal-retreatment period
-Time to flare during the randomized withdrawal-retreatment period
-Time to flare during the randomized withdrawal-retreatment period |
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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 | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
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 |
Japan |
Korea, Democratic People's Republic of |
Mexico |
Puerto Rico |
Russian Federation |
Taiwan |
United States |
Austria |
Finland |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Romania |
Spain |
United Kingdom |
Czechia |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |