Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

NCT01544595 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457A2302E12012-000533-39
• Study Type: interventional
• Target: 1,147
• Locations: 25 countries
• Sites: 176

Brief Summary

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

Conditions

Moderate to Severe Plaque-type Psoriasis

Keywords

Psoriasis, inflammatory skin disease; scaly patches; secukinumab (AIN457); Psoriasis Area and Severity Index (PASI); Investigator Global Assessment (IGA) mod 2011

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68

  The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.

  At week 68 (16 weeks after week 52)

Secondary Outcomes (21)

• Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period

  Week 52, 104, and 156

• Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period

  Week 52, Week 104, Week 156, week 208, week 260

• Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period

  Week 52, 104, and 156

• Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period

  Week 52, Week 104, Week 156, week 208, week 260

• Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period

  Week 52 (baseline), 104, and 156

Study Arms (2)

PASI 75 Responders

PLACEBO COMPARATOR

PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.

Drug: Secukinumab (AIN457); Drug: Placebo

Partial responders

EXPERIMENTAL

Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies.

Drug: Secukinumab (AIN457)

Interventions

Secukinumab (AIN457) DRUG

Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.

PASI 75 Responders; Partial responders

Placebo DRUG

Placebo

PASI 75 Responders

Eligibility Criteria

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

You may qualify if:

• Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.
• Written informed consent form.

You may not qualify if:

• A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.
• Ongoing use of prohibited psoriasis or non-psoriasis treatments.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/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 (182)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35233, United States

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Phoenix, Arizona, 85013, United States

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Phoenix, Arizona, 85032, United States

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Los Angeles, California, 90045, United States

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Oceanside, California, 92056, United States

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Pasadena, California, 91105, United States

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San Diego, California, 92103, United States

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San Diego, California, 92123, United States

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Colorado Springs, Colorado, 80915, United States

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Snellville, Georgia, 30078, United States

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Indianapolis, Indiana, 46256, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40241, United States

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Louisville, Kentucky, 40291, United States

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Ann Arbor, Michigan, 48109, United States

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Omaha, Nebraska, 68144, 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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Warren, Ohio, 44483, United States

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Oregon City, Oregon, 97045, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97223, United States

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Duncansville, Pennsylvania, 16635, United States

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Philadelphia, Pennsylvania, 19104, United States

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Johnston, Rhode Island, 02919, United States

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Charleston, South Carolina, 29407, United States

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Kingsport, Tennessee, 37660, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78759, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246-1613, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84117, United States

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Norfolk, Virginia, 23507, United States

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CABA, Buenos Aires, C1062ABK, Argentina

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CABA, Buenos Aires, C1122AAF, Argentina

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CABA, Buenos Aires, C1181ACH, Argentina

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CABA, Buenos Aires, C1425BEI, Argentina

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Buenos Aires, C1425DKG, Argentina

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Mendoza, M5502EZA, Argentina

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Kogarah, New South Wales, 2217, Australia

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Woolloongabba, Queensland, 4102, Australia

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Carlton, Victoria, 3053, Australia

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East Melbourne, Victoria, 3002, Australia

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Liège, 4000, Belgium

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Edmonton, Alberta, T5K 1X3, Canada

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Surrey, British Columbia, V3V 0C6, Canada

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Vancouver, British Columbia, V5Z 4E8, Canada

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Moncton, New Brunswick, E1C 8X3, Canada

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Halifax, Nova Scotia, B3H 1Z2, Canada

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Hamilton, Ontario, L8N 1V6, Canada

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Markham, Ontario, L3P 1A8, Canada

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Peterborough, Ontario, K9J 5K2, Canada

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Richmond Hil, Ontario, L4B 1A5, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Montreal, Quebec, H3H 1V4, Canada

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Sainte-Foy, Quebec, G1V 4X7, Canada

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Barranquilla, Atlántico, Colombia

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Barranquilla, Colombia

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Bogotá, 110221, Colombia

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Tallinn, 10138, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Helsinki, 00250, Finland

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Paris, Cedex 10, 75475, France

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Bordeaux, 33075, France

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Marseille, 13913, France

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Martigues, 13500, France

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Nice, 06202, France

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Reims, 51090, France

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Toulouse, 31400, France

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Cologne, North Rhine-Westphalia, 50937, Germany

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Augsburg, 86179, Germany

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Berlin, 10117, Germany

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Berlin, 10789, Germany

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Berlin, 13187, Germany

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Bielefeld, 33647, Germany

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Bochum, 44791, Germany

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Bochum, 44793, Germany

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Bonn, 53105, Germany

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Darmstadt, 64283, Germany

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Dresden, 01307, Germany

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Erfurt, 99089, Germany

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Erlangen, 91054, Germany

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Essen, 45122, Germany

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Frankfurt, 60590, Germany

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Gera, 07548, Germany

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Göttingen, 37075, Germany

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Greifswald, 17475, Germany

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Hamburg, 20354, Germany

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Hamburg, 22143, Germany

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Hamburg, 22391, Germany

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Hanau, 63450, Germany

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Heidelberg, 69115, Germany

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Kiel, 24105, Germany

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Krefeld, 47805, Germany

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München, 80802, Germany

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Münster, 48149, Germany

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Osnabrück, 49074, Germany

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Plauen, 08529, Germany

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Recklinghausen, 45657, Germany

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Schwerin, 19055, Germany

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Tübingen, 72076, Germany

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Wuppertal, 42275, Germany

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Guatemala City, 01010, Guatemala

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Guatemala City, 01015, Guatemala

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Budapest, 1134, Hungary

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Debrecen, 4032, Hungary

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Kaposvár, 7400, Hungary

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Miskolc, 3529, Hungary

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Szeged, H-6725, Hungary

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Szombathely, 9700, Hungary

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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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Catania, CT, 95123, Italy

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Modena, MO, 41124, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Fukuoka, Fukuoka, 814-0180, Japan

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Kurume, Fukuoka, 830-0011, Japan

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Maebashi, Gunma, 371 8511, Japan

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Asahikawa, Hokkaido, 078-8510, Japan

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Sapporo, Hokkaido, 060-0063, Japan

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Kobe, Hyōgo, 654-0155, Japan

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Inashiki-gun, Ibaraki, 300-0395, Japan

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Isehara, Kanagawa, 259-1193, Japan

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Kawasaki, Kanagawa, 213-8507, Japan

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Sagamihara, Kanagawa, 228-8522, Japan

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Kyoto, Kyoto, 602-8566, Japan

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Bunkyo Ku, Tokyo, 113 8655, Japan

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Chiyoda-ku, Tokyo, 102-8798, 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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Shinjuku-ku, Tokyo, 160-0023, Japan

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Shinjuku-ku, Tokyo, 160-8582, Japan

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Daugavpils, LVA, LV-5404, Latvia

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Ventspils, LVA, LV-3601, Latvia

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Riga, 1012, Latvia

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Riga, LV-1001, Latvia

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Kaunas, LTU, LT-50161, Lithuania

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Klaipėda, LTU, 92304, Lithuania

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Vilnius, LT-07195, Lithuania

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Vilnius, LT-08661, Lithuania

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Lodz, 90-265, Poland

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Lodz, 90-436, Poland

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Poznan, 60 529, Poland

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Wroclaw, 50-368, Poland

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Bucharest, 041335, Romania

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Singapore, 119074, Singapore

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Daejeon, Korea, 35015, South Korea

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Seoul, Korea, 05505, South Korea

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Seoul, Korea, 06351, South Korea

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Seoul, Seocho-gu, 06591, South Korea

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Busan, 49241, South Korea

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Gwangju, 61469, South Korea

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Seoul, 03722, South Korea

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Seoul, 05030, South Korea

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Seoul, 156-755, South Korea

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Sabadell, Barcelona, 08208, Spain

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Santa Coloma de Gramanet, Catalonia, 08923, Spain

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Valencia, Valencia, 46014, Spain

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Barcelona, 08041, Spain

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Madrid, 28031, Spain

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Madrid, 28041, Spain

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Malmo, SE-205 02, Sweden

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Uppsala, 751 85, Sweden

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Taoyuan District, Taiwan, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 10002, Taiwan

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Plymouth, Devon, PL6 8DH, United Kingdom

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London, England, E11 1NR, United Kingdom

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Salford, Manchester, M6 8HD, United Kingdom

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Yeovil, Somerset, BA21 4AT, United Kingdom

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Dudley, West Midlands, DY1 2HQ, United Kingdom

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Harrogate, HG2 7SX, United Kingdom

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Nuneaton, CV10 7DJ, United Kingdom

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Related Publications (1)

• Langley RG, Sofen H, Dei-Cas I, Reich K, Sigurgeirsson B, Warren RB, Paul C, Szepietowski JC, Tsai TF, Hampele I, You R, Charef P, Papavassilis C. Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials. Br J Dermatol. 2023 Feb 10;188(2):198-207. doi: 10.1093/bjd/ljac040.

  PMID: 36763857 DERIVED

MeSH Terms

Conditions

Psoriasis; Dermatitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 6, 2012
• Study Start: June 19, 2012
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: December 20, 2018
• Results First Posted: December 20, 2018

Record last verified: 2018-11

Locations

ES (3); BE (3); LA (4); US (37); TW (3); KR (9); GB (7); SE (2); PL (4); IL (3); CA (12); FI (1); LI (4); SG (1); AR (6); DE (33); GU (2); HU (6); IC (1); CO (3); FR (7); AU (4); IT (2); JP (18); RO (1)