E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis is a systemic inflammatory disorder that causes red, raised scaly patches on the skin.
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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 | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
• Efficacy of mirikizumab induction dosing compared to placebo in subjects based on sPGA (0,1) and PASI 90 at Week 16 |
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E.2.2 | Secondary objectives of the trial |
• Efficacy of mirikizumab induction dosing compared to placebo based on PASI 75 at Week 4;
• Efficacy of mirikizumab induction dosing compared to placebo based on PASI 75, PASI 100, BSA ≤1% , PSS symptoms score of 0 in those with a PSS symptoms score ≥1 at baseline and and DLQI (0,1) with at least a 5-point improvement (reduction) from baseline with DLQI baseline score ≥5 at Week 16
• Efficacy of mirikizumab induction dosing compared to secukinumab based on sPGA (0,1) and PASI 90 at Week 16; |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Present with chronic plaque psoriasis based on an investigator-confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline, and meet the following criteria:: a) involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening (Visit 1) and baseline (Visit 2), and b) sPGA score of ≥3 at screening (Visit 1) and baseline (Visit 2). - Candidate for systemic therapy and/or phototherapy - Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial - Are ≥18 years of age
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E.4 | Principal exclusion criteria |
- Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety within the study or of interfering with the interpretation of data. - Are women who are breastfeeding or plan to breastfeed during study - Have had serious, opportunistic or chronic/recurring infection within 3 months prior to screening - Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study. - Have any other skin conditions (excluding plaque psoriasis) that would affect interpretation of the results - Have received systemic nonbiologic therapy within 28 days prior to baseline - Have received topical treatment within 14 days prior to baseline - Have prior use of secukinumab - Have received anti-tumor necrosis factor (TNF) targeting biologics within 8 weeks prior to baseline - Have previous exposure to any biologic therapy targeting IL-12/23 (p40 subunit) or IL-23 (p19 subunit) or IL-17, either marketed or investigational. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Static Physician's Global Assessment (sPGA)(0,1) and Psoriasis Area and Severity Index 90 (PASI 90) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoints to assess whether mirikizumab induction dosing is superior to placebo: Week 16- sPGA (0,1) PASI 90
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E.5.2 | Secondary end point(s) |
PASI 75, PASI 100, BSA ≤1% with psoriasis involvement, PSS, DLQI, PASI 90, sPGA (0,1) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints to assess whether mirikizumab induction dosing is superior to placebo: Week 4- PASI 75 Week 16- PASI 75, PASI 100, BSA ≤1% with psoriasis involvement, PSS symptoms, DLQI
Timepoints to assess whether mirikizumab induction dosing is noninferior to secukinumab: Week 24- PASI 90 Week 52- sPGA (0,1), PASI 90, PASI 100
Timepoint to assess whether mirikizumab maintenance Q8W dosing is superior to secukinumab Week 52- sPGA (0,1) PASI 90
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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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
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 |
Australia |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Poland |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |