Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

AIN457 Regimen Finding Extension Study in Patients With Moderate to Severe Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01132612
First received: May 19, 2010
Last updated: August 2, 2016
Last verified: August 2016

May 19, 2010
August 2, 2016
May 2010
November 2016   (final data collection date for primary outcome measure)
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 ]
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 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01132612 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 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 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
AIN457 Regimen Finding Extension Study in Patients With Moderate to Severe Psoriasis
A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
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.

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.

In the Proof-of-Concept study (CAIN457A2102), AIN457 has proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study has been started (CAIN457A2211).

The data gathered in this extension study of the core study (CAIN457A2211) will be used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The patients in the extension study will continue to stay on the exact same treatment regimen they were taking when completing the core study.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Plaque-type Psoriasis
  • Drug: AIN457
    secukinumab
  • Drug: Placebo
    placebo
  • Experimental: Fixed-time interval regimen
    Fixed-time interval regimen
    Intervention: Drug: AIN457
  • Experimental: Treatment at start of relapse regimen
    Treatment at start of relapse regimen
    Intervention: Drug: AIN457
  • Experimental: Open-label
    Open-label
    Intervention: Drug: AIN457
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
276
November 2016
November 2016   (final data collection date for primary outcome measure)

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Iceland,   Israel,   Japan,   Norway
 
NCT01132612
CAIN457A2211E1, 2009-017234-51
No
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP