E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adjunctive therapy to standard-of-care for the treatment of intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet's disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036370 |
E.1.2 | Term | Posterior uveitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022557 |
E.1.2 | Term | Intermediate uveitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033687 |
E.1.2 | Term | Panuveitis |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet’s patients with intermediate uveitis, posterior uveitis or panuveitis in Group 1 |
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E.2.2 | Secondary objectives of the trial |
Key secondary : • To determine if continuous treatment with subcutaneous AIN457 can reduce the need for standard-of-care immunosuppressive medications in Group 1 patients requiring systemic immunosuppression to treat or prevent intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease Secondary : • To assess the safety of continuous targeted IL-17 inhibition with AIN457 in Group 1 patients with intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease receiving treatment over the course of 1 year • To allow for an adequate treatment-free safety follow up period (12 weeks post-treatment) for patients who discontinued treatment in the core study or who have completed the treatment period in the core study and do not wish to continue study treatment in the extension study (Group 2)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Population: Patients with intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease enrolled in the core study. In the extension study patients may elect to continue study treatments (Group 1) or only to complete the treatment-free safety follow-up period (Group 2). Inclusion for Group 1 : • Patients who have completed the entire treatment period of the 24-week core study • Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed. Inclusion for Group 2 : • Patients who were randomized into 24-week core study and did not complete the treatment period or will not continue in the extension treatment phase.
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E.4 | Principal exclusion criteria |
Exclusion for Group 1 : • Inability or unwillingness to undergo repeated subcutaneous injections • Inability to comply with study or follow-up procedures. • Any medical or psychiatric condition which, in the investigator’s opinion would preclude the participant from adhering to the protocol or completing the study per protocol. • Active systemic infections during the last two weeks (exception: common cold) prior Visit16 that in the opinion of the study investigator or sponsor that would be a contraindication to additional treatment with AIN457. • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) • Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant unless : They are using simultaneously double barrier or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, condom plus spermicidal gel, diaphragm plus condom, etc., hormone replacement as either oral or implantable is acceptable as one form), from the time of screening and for the duration of the study, through study completion and for 16 weeks after study drug discontinuation. [Note: Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), spermicides alone without condoms or cervical caps and withdrawal are not considered acceptable methods of contraception.] They are postmenopausal with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing. Menopause must be confirmed by a plasma FSH level of >40 IU/L at screening. They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. Their career, lifestyle, or sexual orientation precludes intercourse with a male partner. Partners have been sterilized by vasectomy or other reliable means. Male subjects must agree to use simultaneously two acceptable methods of contraception (e.g. condom plus spermicidal gel) for the entire duration of the study, up to the study completion visit, unless they have undergone a vasectomy more than six (6) months prior to first dosing. A vasectomy must be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History/ Current Medical Conditions sections of the CRF. Periodic abstinence or withdrawal are not acceptably adequate methods of contraception.
There are no Exclusion criteria for Group 2.
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E.5 End points |
E.5.1 | Primary end point(s) |
The rationale for the additional 26 weeks of treatment following the 24 week core study is to provide additional data on the safety and efficacy of AIN457 given over the course of 1 year. |
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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 | Yes |
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
| 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 | 24 |
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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LPLV performed at week 52 with follow-up period to week 62 |
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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 | |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |