AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

NCT00941031 | Completed Phase 2 Results

• 2 other identifiers: CAIN457A22112008-007525-39
• Study Type: interventional
• Target: 404
• Locations: 7 countries
• Sites: 62

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).

Conditions

Chronic Plaque-type Psoriasis

Keywords

Moderate to severe chronic plaque-type psoriasis; AIN457; dermatology

Outcome Measures

Primary Outcomes (1)

• 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.

  Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment

  13 weeks

Secondary Outcomes (2)

• The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29

  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

  13 weeks

Study Arms (4)

Induction Single Dose

EXPERIMENTAL

Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12

Drug: AIN457

Induction Monthly Dose

EXPERIMENTAL

Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12

Drug: AIN457A

Induction Early Loading Dose

EXPERIMENTAL

Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12

Drug: AIN457A

Placebo Dose

PLACEBO COMPARATOR

Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12

Drug: Placebo

Interventions

AIN457 DRUG

Also known as: Secukinumab

Induction Single Dose

AIN457A DRUG

Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9

Also known as: Secukinumab

Induction Monthly Dose

Placebo DRUG

Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

Placebo Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (62)

Novartis Investigative Site

Birmingham, Alabama, 35233, United States

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Little Rock, Arkansas, 72205, United States

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Pasadena, California, 91105, United States

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San Diego, California, 92123, United States

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Newnan, Georgia, 30263, United States

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Snellville, Georgia, 30078, United States

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Champaign, Illinois, 61820, United States

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Springfield, Illinois, 62703, United States

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Evansville, Indiana, 47713, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40217, United States

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Boston, Massachusetts, 02111, United States

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Clinton Twp., Michigan, 48038, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63117, United States

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Omaha, Nebraska, 68131, United States

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Omaha, Nebraska, 68144, United States

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Henderson, Nevada, 89052, United States

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New York, New York, 10029, United States

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Rochester, New York, 14623, United States

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High Point, North Carolina, 27262, United States

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Lake Oswego, Oregon, 97035, United States

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Portland, Oregon, 97210, United States

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Philadelphia, Pennsylvania, 19104, United States

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Austin, Texas, 78759, United States

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Dallas, Texas, 75204, United States

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Charlottesville, Virginia, 22911, United States

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Lynchburg, Virginia, 24501, United States

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Toulouse, France, 31059, France

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Nice, 06202, France

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Berlin, 10117, Germany

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Bonn, 53105, Germany

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Dresden, 01307, Germany

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Erlangen, 91054, Germany

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Frankfurt, 60590, Germany

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Göttingen, 37075, Germany

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Hamburg, 20354, Germany

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Hanover, 30625, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Lübeck, 23538, Germany

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Mainz, 55131, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Kopavogur, 201, Iceland

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Afula, 18101, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Nagoya, Aichi-ken, 467-8602, Japan

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Fukuoka, Fukuoka, 814-0180, Japan

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Kitakyushu, Fukuoka, 807-8556, Japan

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Kurume, Fukuoka, 830-0011, Japan

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Maebashi, Gunma, 371-8511, Japan

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Chitose, Hokkaido, 066-0021, Japan

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Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8655, Japan

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Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

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Minato-ku, Tokyo, 105-8471, Japan

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Shinagawa-ku, Tokyo, 141-8625, Japan

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Novartis Investigative Site

Ålesund, 6017, Norway

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Bergen, NO-5021, Norway

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Novartis Investigative Site

Oslo, 0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 24393602 DERIVED

MeSH Terms

Interventions

secukinumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 20, 2015
• Results First Posted: March 27, 2015

Record last verified: 2015-03

Locations

IL (3); DE (14); FR (2); IC (1); JP (10); NO (3); US (29)