Moderate to severe plaque-type psoriasis MedDRA version: 14.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who completed the previous core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including the End of treatment visit 13 (F4). - Patients 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 assessment is performed. - Patients must be expected to benefit from ongoing treatment with AIN457, as assessed by the patient and the investigator. - Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration. Reliable contraception is defined as using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants (by the partner), injectables, combined oral contraceptives (by the partner), and some intrauterine devices (by the partner); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 258 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - Patients who experience a second consecutive full relapse at the End of treatment visit 13 (week F4) of the core study CAIN457A2211 - 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 child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of subcutaneously administered AIN457 in the treatment of moderate to severe chronic plaque-type psoriasis.;Secondary Objective: - To evaluate the long-term efficacy of subcutaneously administered AIN457 in the treatment of moderate to severe chronic plaque-type psoriasis, assessed by two approved psoriasis-specific measurement tools, the Psoriasis Area and Severity Index (PASI) and by the Investigator’s Global Assessment (IGA). - To evaluate the long-term immunogenicity (anti-AIN457 antibodies) of subcutaneously administered AIN457 in the treatment of moderate to severe chronic plaque-type psoriasis. ;Primary end point(s): Assessment of vital signs, clinical laboratory variables and adverse events reporting during the study;Timepoint(s) of evaluation of this end point: At every visit (every 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- To evaluate the long-term efficacy of AIN457 treatment as assessed by PASI 50, PASI 75 and PASI 90 achievement over time during the trial up to 4 weeks after last study drug administration 2- To evaluate the efficacy of AIN457 treatment as assessed by IGA over time during the trial up to 4 weeks after last study drug administration 3- To evaluate the long-term immunogenicity as assessed by the development of immunogenicity against AIN457 during the trial ;Timepoint(s) of evaluation of this end point: At every 4 weeks (1 and 2) Every 12 weeks initially then 24 weeks (3) | — |
Countries
France, Germany, Iceland, Israel, Japan, Norway, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed