AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

• 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: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: July 16, 2009
• First Posted Date: July 17, 2009
• Results First Submitted Date: January 30, 2015
• Results First Posted Date: March 27, 2015
• Last Update Posted Date: August 20, 2015
• Study Start Date: July 2009
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Plaque-type Psoriasis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2011): 404
• Original Estimated Enrollment (submitted: July 16, 2009): 396
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Iceland, Israel, Japan, Norway, United States
• Removed Location Countries: Finland, Netherlands

Administrative Information

• NCT Number: NCT00941031
• Other Study ID Numbers: CAIN457A2211; 2008-007525-39 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: External Affairs, Novartis Pharmaceuticals
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2015