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ACTIVE NOT RECRUITING
NCT04179175
PHASE3

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

Official title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

703

Start Date

2020-03-18

Completion Date

2026-07-15

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

secukinumab

secukinumab 300mg every 2 weeks

DRUG

secukinumab

secukinumab 300mg every 4 weeks

Locations (191)

Northwest Arkansas Center

Rogers, Arkansas, United States

MedDerm Associates

San Diego, California, United States

University Clinical Trials

San Diego, California, United States

Southern California Skin and Laser

Whittier, California, United States

Florida Academic Centers Research and Education LLC

Coral Gables, Florida, United States

University of MiamiHealth System

Miami, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

University Of South Florida

Tampa, Florida, United States

Advanced Medical Research

Sandy Springs, Georgia, United States

Endeavor Health

Glenview, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Med Center

Boston, Massachusetts, United States

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

St Louis U Clinical Trials

St Louis, Missouri, United States

WA Uni School Of Med

St Louis, Missouri, United States

Skin Specialists PC

Omaha, Nebraska, United States

Icahn School Of Med At Mount Sinai

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Wright State University

Fairborn, Ohio, United States

UP Medical Center H System

Pittsburgh, Pennsylvania, United States

Clinical Research Ctr of Carolinas

Charleston, South Carolina, United States

Bellaire Dermatology Associates

Bellaire, Texas, United States

MDRI Baylor University

Dallas, Texas, United States

Austin Inst for Clinical Research

Pflugerville, Texas, United States

Dr. Stephen Miller, MDPA

San Antonio, Texas, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

Phillip, Australian Capital Territory, Australia

Novartis Investigative Site

Benowa, Queensland, Australia

Novartis Investigative Site

East Melbourne, Victoria, Australia

Novartis Investigative Site

Linz, Austria

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Vienna, Austria

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Brussels, Brussels Capital, Belgium

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Ghent, Belgium

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Liège, Belgium

Novartis Investigative Site

Pleven, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

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Sofia, Bulgaria

Novartis Investigative Site

Stara Zagora, Bulgaria

Novartis Investigative Site

Barrie, Ontario, Canada

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London, Ontario, Canada

Novartis Investigative Site

Peterborough, Ontario, Canada

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Waterloo, Ontario, Canada

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Zagreb, HRV, Croatia

Novartis Investigative Site

Prague, Prague 1, Czechia

Novartis Investigative Site

Jihlava, Czechia

Novartis Investigative Site

Plzen Bory, Czechia

Novartis Investigative Site

Ústí nad Labem, Czechia

Novartis Investigative Site

Limoges, Haute Vienne, France

Novartis Investigative Site

Toulon, Val De Marne, France

Novartis Investigative Site

Antony, France

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Bordeaux, France

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Brest, France

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Créteil, France

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Lyon, France

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Martigues, France

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Montpellier, France

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Nantes, France

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Nice, France

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Paris, France

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Reims, France

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Rouen, France

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Saint-Mandé, France

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Saint-Priest-en-Jarez, France

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Toulouse, France

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Langenau, Baden-Wurttemberg, Germany

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Munich, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Halle, Saxony-Anhalt, Germany

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Berlin, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bochum, Germany

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Erlangen, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Memmingen, Germany

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München, Germany

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Münster, Germany

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Potsdam, Germany

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Schwerin, Germany

Novartis Investigative Site

Athens, Greece

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Chaïdári, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

Novartis Investigative Site

Guatemala City, Guatemala

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Guatemala City, Guatemala

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Pécs, Baranya, Hungary

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Debrecen, Hajdu Bihar Megye, Hungary

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Kaposvár, Hungary

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Mysore, Karnataka, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Jerusalem, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Ancona, AN, Italy

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Cona, FE, Italy

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Florence, FI, Italy

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Milan, MI, Italy

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Pisa, PI, Italy

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Roma, RM, Italy

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Naples, Italy

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Nagoya, Aichi-ken, Japan

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Kisarazu, Chiba, Japan

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Ginowan, Okinawa, Japan

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Koshigaya, Saitama, Japan

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Itabashi-ku, Tokyo, Japan

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Osaka, Japan

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Saida, Lebanon

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Kaunas, LTU, Lithuania

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Vilnius, Lithuania

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Kuala Lumpur, Kuala Lumpur, Malaysia

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George Town, Pulau Pinang, Malaysia

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Johor Bahru, Malaysia

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Amersfroort, Utrecht, Netherlands

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Las Piñas, Philippines

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Makati City, Philippines

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Warsaw, Mazowian, Poland

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Ossy, Poland

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Rzeszów, Poland

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Warsaw, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Lisbon, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Chelyabinsk, Russia

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Kazan', Russia

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Krasnodar, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Yaroslavl, Russia

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Singapore, Singapore

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Singapore, Singapore

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Banská Bystrica, Slovakia

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Košice, Slovakia

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Prešov, Slovakia

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Raslouw Centurion, Gauteng, South Africa

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Soweto, Gauteng, South Africa

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, South Korea

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Cadiz, Andalusia, Spain

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Granada, Andalusia, Spain

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Barcelona, Catalonia, Spain

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Fuenlabrada, Madrid, Spain

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Manises, Valencia, Spain

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Alicante, Spain

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Barcelona, Spain

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Las Palmas GC, Spain

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Madrid, Spain

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Madrid, Spain

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Pontevedra, Spain

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Bern, Switzerland

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Geneva, Switzerland

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Lausanne, Switzerland

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Aydin, Efeler, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

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Antalya, Konyaalti, Turkey (Türkiye)

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Kayseri, Melikgazi, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Pendik, Turkey (Türkiye)

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Gaziantep, Sehitkamil, Turkey (Türkiye)

Novartis Investigative Site

Exeter, Devon, United Kingdom

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Dudley, West Midlands, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Barnsley, United Kingdom

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Bristol, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Salford, United Kingdom

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Hanoi, Vietnam

Novartis Investigative Site

Ho Chi Minh City, Vietnam