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 that often itch or bleed and are painful. |
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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 |
To access long-term maintenance of efficacy of mirikizumab in subjects based upon sPGA (0, 1) and ≥90% improvement in PASI 90 among those who entered Study AMAH with sPGA (0,1) and PASI 90 response. |
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E.2.2 | Secondary objectives of the trial |
To access long term efficacy and patient reported outcomes with mirikizumab treatment in subjects based upon sPGA (0,1), PASI 90, PASI 100, PSS symptoms score of 0 in those with a PSS symptoms score ≥1 at baseline, (DLQI) score of 0,1 with baseline score >1 and % change in (PPASI), (PSSI) and (NAPSI). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Have completed the last visit of an eligible study period of 1 of the originator studies (Study AMAF, AMAJ, AMAK, or AMBK).
- Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial
-Have given written informed consent as a legal adult according to local regulations
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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.
- Have a known hypersensitivity to mirikizumab or any component of this investigational product.
- Have had investigational product permanently discontinued during a previous mirikizumab study.
- Have had temporary investigational product interruption at any time during or at the final study visit of a previous mirikizumab study and, in the opinion of the investigator, restarting mirikizumab would pose 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
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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 |
Over the course of the study
•Proportion of patients with an sPGA (0,1) and ≥90% improvement in PASI (PASI 90) among those who entered Study AMAH with sPGA (0,1) and PASI 90 response
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E.5.2 | Secondary end point(s) |
sPGA (0,1), PASI 90, PASI 100, PSS symptoms score, DLQI, PPASI, PSSI and NAPSI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Over the course of the study
•Proportion of patients achieving sPGA (0,1), PASI 90, PASI 100
•Proportion of patients achieving PSS symptom score of 0 & in those with a PSS symptoms score ≥1 at baseline and (DLQI) score of 0,1 with baseline score >1
•Percent change in total score of PPASI, PSSI and NAPSI in those with palmoplantar involvement, scalp involvement and fingernail involvement at baseline
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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 | 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 | Yes |
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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
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 |
Israel |
Japan |
Korea, Republic of |
Mexico |
Russian Federation |
Taiwan |
United States |
Czechia |
France |
Germany |
Hungary |
Italy |
Poland |
Spain |
United Kingdom |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |