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 |
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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 vs placebo based on sPGA and PASI 90 at Week 16 |
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E.2.2 | Secondary objectives of the trial |
- Efficacy of mirikizumab induction dosing over placebo based on PASI 75 at Week 4; PASI 75, PASI 100, BSA and DLQI at Week 16.
- Efficacy of mirikizumab maintenance dosing vs placebo based on PASI 90 at Week 52.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol Addendum I6T-MC-AMAK(2), version dated 31 Jan 2018
A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis OASIS – 1
This addendum is to be performed in addition to all procedures required by protocol I6T-MC-AMAK or any subsequent amendments to that protocol.
The purpose of this Study I6T-MC-AMAK (AMAK) protocol addendum is to provide photographic documentation of the clinical response of patients with moderate-to-severe plaque psoriasis to treatment with mirikizumab
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E.3 | Principal inclusion criteria |
- Present with chronic plaque psoriasis:
A. Plaque psoriasis involving ≥10% body surface area and absolute PASI score ≥12 in affected skin
B. sPGA score of ≥3
- Candidate for systemic therapy and/or phototherapy
- Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception
- Are ≥18 years of age
- Have adequate organ function
- Have given written informed consent |
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E.4 | Principal exclusion criteria |
- Have an unstable or uncontrolled illness
- Presence of significant uncontrolled neuropsychiatric disorder
- Have human immunodeficiency virus, acquired immune deficiency syndrome, or test positive human HIV antibodies at screening
- Have hepatitis C or test positive for hepatitis C virus at screening
- Have hepatitis B or test positive for hepatitis B virus at screening
- Are women who are breastfeeding or plan to breastfeed during study
- Have received systemic nonbiologic therapy within 28 days prior to baseline
- Have received topical treatment within 14 days prior to baseline
- Have received anti-TNF targeting biologics within 8 weeks prior to baseline, or anti-IL-17 targeting biologics within 12 weeks prior to baseline
- Have previous exposure to any biologic therapy targeting IL-12/23 or IL-23 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Static Physician’s Global Assessment (sPGA) 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 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, Week 16 and Week 52 |
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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 | 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 | 3 |
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 | 12 |
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 |
Germany |
Japan |
Korea, Republic of |
Mexico |
Poland |
Russian Federation |
Taiwan |
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 | 8 |