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Trial record 4 of 107 for:    ain457

AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT00941031
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : March 27, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 16, 2009
First Posted Date  ICMJE July 17, 2009
Results First Submitted Date  ICMJE January 30, 2015
Results First Posted Date  ICMJE March 27, 2015
Last Update Posted Date August 20, 2015
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. [ Time Frame: 13 weeks ]
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
To evaluate the efficacy of three induction regimens of AIN457 administered subcutaneously in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement after 12 weeks of treatment, compared to placebo. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29 [ Time Frame: week 21 to 29 ]
  • The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo [ Time Frame: 13 weeks ]
    The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
  • To compare the efficacy of two maintenance regimens of AIN457 with respect to PASI 75 achievement at least once from week 21 to 29 [ Time Frame: week 21 to 29 ]
  • To evaluate the efficacy of three induction regimens of AIN457 administered subcutaneously with respect to IGA 0 or 1 achievement after 12 weeks of treatment, compared to placebo [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
Official Title  ICMJE A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plaque-type Psoriasis
Intervention  ICMJE
  • Drug: AIN457
    Other Name: Secukinumab
  • Drug: AIN457A
    Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
    Other Name: Secukinumab
  • Drug: AIN457A
    Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
    Other Name: Secukinumab
  • Drug: Placebo
    Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9
Study Arms  ICMJE
  • Experimental: Induction Single Dose
    Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
    Intervention: Drug: AIN457
  • Experimental: Induction Monthly Dose
    Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
    Intervention: Drug: AIN457A
  • Experimental: Induction Early Loading Dose
    Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
    Intervention: Drug: AIN457A
  • Placebo Comparator: Placebo Dose
    Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
    Intervention: Drug: Placebo
Publications * Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2011)
404
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
396
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women at least 18 years of age at time of consent
  • Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
  • At time of randomization, moderate to severe psoriasis as defined by:

    • PASI score of 12 or greater and
    • IGA score of 3 or greater and
    • Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
  • At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:

    • topical treatment and/or
    • phototherapy and/or
    • previous systemic therapy

Exclusion Criteria:

  • Patients meeting any of the following criteria will be excluded from entry into the study:
  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
  • Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
  • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
  • Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
  • Known immunosuppression (e.g., AIDS) at screening and / or randomization
  • History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
  • Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
  • At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
  • History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
  • History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
  • Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
  • Pregnant or nursing (lactating) women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Iceland,   Israel,   Japan,   Norway,   United States
Removed Location Countries Finland,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00941031
Other Study ID Numbers  ICMJE CAIN457A2211
2008-007525-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2015

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