E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Plaque Psoriasis / Psoriasis Vulgaris |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 objective of this study is to evaluate the efficacy and safety of switching to risankizumab for subjects with moderate to severe plaque psoriasis who have been treated with labeled dose of secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response. Suboptimal response is defined as a static Physician's Global Assessment (sPGA) 2 or 3, and a Body Surface Area (BSA) 3% - < 10% after at least 6 months treatment with secukinumab or ixekizumab. |
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E.2.2 | Secondary objectives of the trial |
The proportion of subjects achieving a static Physician Global Assessment clear response (sPGA 0) at Week 16; • The proportion of subjects achieving a Dermatology Life Quality Index (DLQI) 0 or 1 at Week 16; • The proportion of subjects achieving a Psoriasis Symptoms Scale (PSS) 0 at Week 16; • The proportion of subjects achieving a sPGA 0/1 at Week 52; • The proportion of subjects achieving a sPGA 0 at Week 52; • The proportion of subjects achieving a DLQI 0/1 at Week 52; • The proportion of subjects achieving a PSS 0 at Week 52; • Time to achieve sPGA 0/1; • Time to achieve sPGA 0. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Adult subjects 18 years and older at screening; * Diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0); * Subject must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing a sub-optimal response at time of Screening and Baseline visits * Sub-optimal response to Secukinumab and Ixekizumab inhibitors is defined as: - Body Surface Area (BSA) 3% - <10% and - Static Physician Global Assessment 2/3 * Subject must be eligible for continued biologic therapy as assessed by the investigator |
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E.4 | Principal exclusion criteria |
* History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis * No active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis; * History of chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB /PPD test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines; * Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) as assessed by the investigator; * History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix; * History of major surgery performed within 12 weeks prior to randomization or planned to be performed during the conduct of the trial as assessed by the investigator; * Previous exposure to risankizumab or any IL-23 inhibitors. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving a static Physician's Global Assessment (sPGA) clear (0) or almost clear (1) response at Week 16 |
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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) |
* The proportion of subjects achieving a static Physician Global Assessment clear response (sPGA 0) at Week 16; * The proportion of subjects achieving a Dermatology Life Quality Index (DLQI) 0 or 1 at Week 16; * The proportion of subjects achieving a Psoriasis Symptoms Scale (PSS) 0 at Week 16; * The proportion of subjects achieving a sPGA 0/1 at Week 52; * The proportion of subjects achieving a sPGA 0 at Week 52; * The proportion of subjects achieving a DLQI 0/1 at Week 52; * The proportion of subjects achieving a PSS 0 at Week 52; * Time to achieve sPGA 0/1; * Time to achieve sPGA 0; |
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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) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 28 |
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 |
Australia |
Israel |
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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The end of study is defines as the date of the last subject's last contact, which will be a follow-up phone call 20 weeks after the last dose. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 27 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 27 |