E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe chronic plaque-type psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
moderate to severe chronic plaque-type psoriasis |
|
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 | 17.0 |
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 |
|
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 demonstrate the non-inferiority of the efficacy profile in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks. |
|
E.2.2 | Secondary objectives of the trial |
To compare the proportion of responders to PASI 50/75/90/100 between cohorts at each time point.
To compare the mean changes vs baseline in IGA mod 2011 between cohorts at each time point.
- To compare time to reach PASI 90 between cohorts.
- To compare time to reach PASI 75 between cohorts.
- To evaluate the Quality of Life by means of the Dermatology Life Quality Index (DLQI) in all patients at each time point.
- To evaluate anxiety and depression in all patients at each time point.
- To evaluate the correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI in all patients.
- To evaluate changes from baseline in weight, BMI and waist in all patients at each time point.
- To compare safety and tolerability between cohorts for 24 weeks.
- To evaluate the amount of resources used during the study in comparison with the 6 months prior to the beginning of the study. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.
2. Men or women at least 18 years of age at time of screening.
3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months.
4. Psoriasis of the scalp, hands or diagnosis of concomitant psoriatic arthritis as per CASPAR criteria.
5. Moderate to severe psoriasis as defined at enrollment by:
PASI score ≥ 10
or
PASI score > 5 but < 10 and DLQI ≥10
6. Failed response to at least two systemic therapies (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these). |
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E.4 | Principal exclusion criteria |
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
3. Anti-TNFα therapy within timelines depending on drug half-life.
4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that is not anti-TNFα therapy.
6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
7. Ongoing use of corticosteroid topical treatments or UV therapy. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate the non-inferiority of the efficacy profile in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- To compare the proportion of responders to PASI 50/75/90/100 between cohorts at each time point.
- To compare the mean changes vs baseline in IGA mod 2011 between cohorts at each time point.
- To compare time to reach PASI 90 between cohorts.
- To compare time to reach PASI 75 between cohorts.
- To evaluate the Quality of Life by means of the Dermatology Life Quality Index (DLQI) in all patients at each time point.
- To evaluate anxiety and depression in all patients at each time point.
- To evaluate the correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI in all patients.
- To evaluate changes from baseline in weight, BMI and waist in all patients at each time point.
- To compare safety and tolerability between cohorts for 24 weeks.
- To evaluate the amount of resources used during the study in comparison with the 6 months prior to the beginning of the study. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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) | No |
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 | 35 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |