E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque-type psoriasis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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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 evaluate the efficacy of three induction regimens of AIN457 administered s.c. in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement after 12 weeks of treatment, compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
Key Secondary objectives:
To compare the efficacy of two maintenance regimens of AIN457 with respect to PASI 75 achievement at least once from week 21 to 29
To evaluate the efficacy of three induction regimens of AIN457 administered s.c. with respect to IGA 0 or 1 achievement after 12 weeks of treatment, compared to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria:
• Males or females at least 18 years of age at time of entry
• Diagnosis of chronic plaque-type psoriasis for at least 6 months at time of randomization
• At randomization, moderate to severe psoriasis (PASI ≥ 12, IGA ≥ 3, and BSA ≥ 10%)
• At screening and randomization, psoriasis considered inadequately controlled by topical treatment and / or phototherapy and / or previous systemic therapy
• Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration. |
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E.4 | Principal exclusion criteria |
Key exclusion criteria:
• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
• Drug-induced psoriasis at randomization (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
• Ongoing use of prohibited psoriasis treatments / medications (e.g., topical or systemic corticosteroids, UV therapy) at randomization
• Ongoing use of other prohibited treatments at randomization. All concomitant medication must be on a stable dose for at least four weeks before first study drug administration.
• Known immunosuppression (e.g., AIDS) at screening and / or randomization
• History or evidence to suggest active TB at screening. All patients will be tested for TB status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent TB may enter the trial after sufficient treatment has been initiated according to local regulations.
• Active systemic infections during the last two weeks before randomization (exception: common cold)
• At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint, achievement of PASI 75 at week 13, will be analyzed by Dunnett’s test procedure for proportions in a sequential manner. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Soluble markers, Immunogenicity |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.3 |
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 | 33 |
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 | Information not present in EudraCT |
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 |
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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 | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 10 |