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 |
A type of arthritis associated with psoriasis |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
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 |
The primary objective of the study is to compare ixekizumab 80 mg Q2W with placebo in maintenance of treatment response, as measured by the time to relapse during the randomized double-blind withdrawal period in cDMARD-IR and bDMARD-naive patients with active PsA who meet randomization criteria (Coates criteria for MDA for 3 consecutive months over 4 consecutive visits). |
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E.2.2 | Secondary objectives of the trial |
compare ixekizumab 80mg Q2W with placebo in maintenance of treatment response,measured by the proportion of patients who meet relapse criteria during the randomized double-blind withdrawal period in cDMARD-IR and bDMARD-naive patients with active PsA who meet randomization criteria (Coates criteria for MDA for 3 consecutive mths over 4 consecutive visits)
evaluate the time to loss of response for each individual component of MDA in the randomized double-blind withdrawal period
evaluate time to first meeting Coates criteria for MDA during the initial open-label treatment period
evaluate time to achieving Coates criteria for MDA during the initial open-label treatment period (Coates criteria for MDA for 3 consecutive mths over 4 consecutive visits)
assess the efficacy of ixekizumab 80mg Q2W after disease relapse after
randomization in the randomized double-blind treatment period
assess effect of treatment response as measured by the HAQ-DI of ixekizumab 80mg Q2W throughout study |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] are male or female patients 18 years or older who agree to use reliable method of birth control or remain abstinent during the study
[2] have had diagnosis of active PsA for at least 6 months and meet Classification for Psoriatic Arthritis (CASPAR) criteria
[3] active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
[4] have been treated with 1 or more conventional disease-modifying antirheumatic drugs (DMARDs)
[5] have active psoriatic skin lesions (plaque) or a documented history of plaque psoriasis
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E.4 | Principal exclusion criteria |
Patients will be excluded from study enrollment if they meet any of the following criteria:
[7] have received any previous treatment or are currently receiving treatment with any biologic or small-molecule therapy for PsA or psoriasis
[10] have had, in the opinion of the investigator, inadequate response to treatment with ≥4 cDMARDs or immune modifiers
[12] are receiving treatment with more than 1 cDMARD
[20] have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study
[24] have a diagnosis of other inflammatory arthritic syndromes such as RA, ankylosing spondylitis, reactive arthritis, or enteropathic arthritis
[33] have serious disorder other than psoriatic arthritis
[36] had a serious infection within 12 weeks
[43] are positive for human immunodeficiency virus serology
[44] have evidence of or test positive for hepatitis B or hepatitis C virus
[50] are women who are lactating or breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
Relapse as defined by loss of Coates Criteria for MDA |
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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) |
Tender and swollen joint count, enthesitis, PASI, patient reported outcomes (PRO). |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open-Label period followed by Double Blind period |
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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 | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 |
Argentina |
Bulgaria |
Czech Republic |
Estonia |
Mexico |
Poland |
Russian Federation |
Slovakia |
South Africa |
Spain |
Ukraine |
United Kingdom |
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 | 4 |
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 | 4 |