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

NCT ID: NCT01544595

Last Updated: 2018-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-19

Study Completion Date

2017-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Moderate to Severe Plaque-type Psoriasis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PASI 75 Responders

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.

Group Type PLACEBO_COMPARATOR

Secukinumab (AIN457)

Intervention Type 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.

Placebo

Intervention Type DRUG

Placebo

Partial responders

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.

Group Type EXPERIMENTAL

Secukinumab (AIN457)

Intervention Type 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.

Interventions

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Secukinumab (AIN457)

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.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Snellville, Georgia, United States

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Indianapolis, Indiana, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Ann Arbor, Michigan, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Rochester, New York, United States

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High Point, North Carolina, United States

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Warren, Ohio, United States

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Oregon City, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Charleston, South Carolina, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Kogarah, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Carlton, Victoria, Australia

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East Melbourne, Victoria, Australia

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Brussels, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Markham, Ontario, Canada

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Peterborough, Ontario, Canada

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Richmond Hil, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Barranquilla, Atlántico, Colombia

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Tartu, , Estonia

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Helsinki, , Finland

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Paris, Cedex 10, France

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Bordeaux, , France

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Marseille, , France

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Nice, , France

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Reims, , France

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Toulouse, , France

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Cologne, North Rhine-Westphalia, Germany

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Augsburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Gera, , Germany

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Greifswald, , Germany

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Münster, , Germany

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Osnabrück, , Germany

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Recklinghausen, , Germany

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Wuppertal, , Germany

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Guatemala City, , Guatemala

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Budapest, , Hungary

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Debrecen, , Hungary

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Miskolc, , Hungary

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Szeged, , Hungary

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Szombathely, , Hungary

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Kopavogur, , Iceland

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Afula, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Catania, CT, Italy

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Modena, MO, Italy

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Nagoya, Aichi-ken, Japan

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Fukuoka, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Inashiki-gun, Ibaraki, Japan

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Isehara, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Kyoto, Kyoto, Japan

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Bunkyo Ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Daugavpils, LVA, Latvia

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Ventspils, LVA, Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, LTU, Lithuania

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Klaipėda, LTU, Lithuania

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Vilnius, , Lithuania

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Lodz, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Singapore, , Singapore

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Daejeon, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Seocho-gu, South Korea

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Busan, , South Korea

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Gwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Sabadell, Barcelona, Spain

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Santa Coloma de Gramanet, Catalonia, Spain

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Valencia, Valencia, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Malmo, , Sweden

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Uppsala, , Sweden

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Taoyuan District, Taiwan, Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Plymouth, Devon, United Kingdom

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London, England, United Kingdom

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Salford, Manchester, United Kingdom

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Yeovil, Somerset, United Kingdom

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Dudley, West Midlands, United Kingdom

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Harrogate, , United Kingdom

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Nuneaton, , United Kingdom

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Countries

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Egypt India Mexico United States Argentina Australia Belgium Canada Colombia Estonia Finland France Germany Guatemala Hungary Iceland Israel Italy Japan Latvia Lithuania Poland Romania Singapore South Korea Spain Sweden Taiwan United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36763857 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2012-000533-39

Identifier Type: -

Identifier Source: secondary_id

CAIN457A2302E1

Identifier Type: -

Identifier Source: org_study_id