A multicenter extension trial of subcutaneously administered AIN457 in patients with moderate to severe chronic plaque-type psoriasis - A2211E1

Phase 1

• Conditions: Moderate to severe chronic plaque-type psoriasis; MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2009-017234-51-IS
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-18
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

- Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients who experience a second consecutive full relapse at 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, UNLESS they are:
? women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
? women whose partners have been sterilized by vasectomy or other means
? 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, injectables, combined oral contraceptives, condoms (by the partner) and some intrauterine devices (IUDs); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified