AIN457 Regimen Finding Extension Study in Patients With Moderate to Severe Psoriasis
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01132612
First received: May 19, 2010
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque-type Psoriasis |
Drug: AIN457 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability as measured by the number of patients with Adverse Events and clinically significant changes in vital signs and clinical laboratory variables. [ Time Frame: 81 +157 (prolongation) weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Long-term efficacy as assessed by the number of patients with a PASI 50, PASI 75 and PASI 90 achievement and an improvement of the Investigator' global assessment score during the trial. [ Time Frame: 81 +157 (prolongation) weeks ] [ Designated as safety issue: No ]
- To evaluate the long-term immunogenicity by measuring the number of patients developing anti AIN antibodies during the trial. [ Time Frame: 81 +157 (prolongation) weeks ] [ Designated as safety issue: No ]
| Enrollment: | 275 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fixed-time interval regimen
Fixed-time interval regimen
|
Drug: AIN457 |
|
Experimental: Treatment at start of relapse regimen
Treatment at start of relapse regimen
|
Drug: AIN457 |
|
Experimental: Open-label
Open-label
|
Drug: AIN457 |
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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) of the core study
- Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
- Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
- Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration
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 termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/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
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132612
Show 49 Study Locations
Show 49 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01132612 History of Changes |
| Other Study ID Numbers: | CAIN457A2211E1, 2009-017234-51 |
| Study First Received: | May 19, 2010 |
| Last Updated: | November 6, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut Iceland: Icelandic Medicines Control Agency Israel: Ministry of Health Japan: Ministry of Health, Labor and Welfare Norway: Norwegian Medicines Agency United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Chronic plaque-type psoriasis AIN457 dermatology Moderate to severe chronic plaque-type psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013