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

NCT01132612 | Completed Phase 2 Results

• 2 other identifiers: CAIN457A2211E12009-017234-51
• Study Type: interventional
• Target: 275
• Locations: 7 countries
• Sites: 57

Brief Summary

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Conditions

Plaque-type Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events, Serious Adverse Events and Deaths

  Safety was assessed by frequency of adverse events including serious adverse events.

  up to week 351

Secondary Outcomes (2)

• Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response

  Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)

• Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial

  up to week 351

Study Arms (3)

Fixed-time interval regimen

EXPERIMENTAL

Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter

Drug: AIN457; Drug: Placebo

Treatment at start of relapse regimen

EXPERIMENTAL

Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks

Drug: AIN457; Drug: Placebo

Open-label

EXPERIMENTAL

Secukinumab 150 mg sc administered every 4 weeks

Drug: AIN457

Interventions

AIN457 DRUG

AIN457A 150 mg powder for solution

Fixed-time interval regimen; Open-label; Treatment at start of relapse regimen

Placebo DRUG

Placebo to AIN457A 150 mg powder for solution

Fixed-time interval regimen; Treatment at start of relapse regimen

Eligibility Criteria

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

You may qualify if:

• 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 Note: Due to new data available from the toxicology studies, the need for male contraception was removed.

You may not qualify if:

• 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, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (57)

Novartis Investigative Site

Birmingham, Alabama, 35233, United States

Location

Novartis Investigative Site

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, 40291, United States

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Clinton Township, 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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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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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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Novartis Investigative Site

Nice, 06202, France

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Novartis Investigative Site

Toulouse, 31400, France

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Novartis Investigative Site

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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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, 1834111, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 5265601, 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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Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

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Novartis Investigative Site

Maebashi, Gunma, 371-8511, Japan

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Novartis Investigative Site

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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Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

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Novartis Investigative Site

Shinagawa-ku, Tokyo, 141 8625, Japan

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Novartis Investigative Site

Ålesund, 6017, Norway

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Novartis Investigative Site

Bergen, NO-5021, Norway

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Novartis Investigative Site

Oslo, 0424, Norway

Location

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: May 19, 2010
• First Posted: May 28, 2010
• Study Start: May 11, 2010
• Primary Completion: October 18, 2016
• Study Completion: October 18, 2016
• Last Updated: January 4, 2018
• Results First Posted: December 5, 2017

Record last verified: 2017-12

Locations

DE (13); JP (10); NO (3); US (25); IL (3); FR (2); IC (1)