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New study tracks safety of Long-Term secukinumab use

NCT ID NCT04638647

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 5 times

Summary

This study follows 1,000 patients with autoimmune or inflammatory conditions who have already completed a Novartis trial with secukinumab and are judged to benefit from continued treatment. Participants receive secukinumab injections to monitor long-term safety, including side effects and injection site reactions. The goal is to ensure the drug remains safe for ongoing use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
secukinumab (a biologic injection that targets inflammation)
What this could lead to
If successful, this study will confirm that long-term use of secukinumab is safe for managing autoimmune conditions.
What could go wrong
This is an open-label, single-arm study without a placebo group, so results may be less reliable. It focuses on safety, not effectiveness, and participants already known to benefit were selected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s). 2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study. 3. Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons). 4. Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement. 5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines. Exclusion Criteria: 1. Participant has prematurely discontinued study treatment in the parent protocol. 2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

autoimmune disease Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmunity, inflammation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accurate Clinical Research Inc

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77089, United States

  • Ahmed Arif Medical Research Center

    COMPLETED

    Grand Blanc, Michigan, 48439, United States

  • Altoona Center for Clin Res

    ACTIVE_NOT_RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Arthritis Rheumatology and Bone Disease Associates PA

    COMPLETED

    Voorhees Township, New Jersey, 08043, United States

  • Austin Regional Clinic Rheumatology

    COMPLETED

    Austin, Texas, 78731, United States

  • Center for Rheumatology Research

    COMPLETED

    Woodland Hills, California, 91364, United States

  • Conquest Research

    COMPLETED

    Winter Park, Florida, 32789, United States

  • Dawes Fretzin Clinical Rea Group

    COMPLETED

    Indianapolis, Indiana, 46256, United States

  • Denver Arthritis Clinic

    COMPLETED

    Denver, Colorado, 80230, United States

  • FL Medical Clinic Orlando Health

    RECRUITING

    Zephyrhills, Florida, 33542, United States

  • Homestead Assoc In Research Inc

    COMPLETED

    Homestead, Florida, 33033, United States

  • IRIS Research and Development

    COMPLETED

    Plantation, Florida, 33324, United States

  • Inland Rheumatology Clinical Trials INC

    COMPLETED

    Upland, California, 91786, United States

  • Klein and Associates

    COMPLETED

    Hagerstown, Maryland, 21740, United States

  • Medvin Clinical Research

    COMPLETED

    Van Nuys, California, 91405, United States

  • Novartis Investigative Site

    COMPLETED

    Vitória, Espírito Santo, 29055-450, Brazil

  • Novartis Investigative Site

    COMPLETED

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Novartis Investigative Site

    COMPLETED

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • Novartis Investigative Site

    COMPLETED

    São José do Rio Preto, São Paulo, 15090 000, Brazil

  • Novartis Investigative Site

    COMPLETED

    São Paulo, São Paulo, 01244-030, Brazil

  • Novartis Investigative Site

    COMPLETED

    São Paulo, São Paulo, 04266-010, Brazil

  • Novartis Investigative Site

    COMPLETED

    Rio de Janeiro, 20241-180, Brazil

  • Novartis Investigative Site

    COMPLETED

    Plovdiv, Bulgaria, 4002, Bulgaria

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Sofia, Bulgaria, 1407, Bulgaria

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Stara Zagora, Bulgaria, 6000, Bulgaria

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    COMPLETED

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    COMPLETED

    Sofia, 1784, Bulgaria

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hefei, Anhui, 230601, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Novartis Investigative Site

    COMPLETED

    Chongqing, Chongqing Municipality, 400010, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Xiamen, Fujian, 361001, China

  • Novartis Investigative Site

    COMPLETED

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    COMPLETED

    Guangzhou, Guangdong, 510120, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shantou, Guangdong, 515000, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shenzhen, Guangdong, 518020, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Changsha, Hunan, 410011, China

  • Novartis Investigative Site

    COMPLETED

    Zhuzhou, Hunan, 412000, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Baotou, Inner Mongolia, 014010, China

  • Novartis Investigative Site

    COMPLETED

    Hohhot, Inner Mongolia, 010050, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yangzhou, Jiangsu, 225001, China

  • Novartis Investigative Site

    COMPLETED

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Pingxiang, Jiangxi, 337000, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    COMPLETED

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kunming, Yunnan, 650000, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Beijing, 100000, China

  • Novartis Investigative Site

    COMPLETED

    Beijing, 100050, China

  • Novartis Investigative Site

    COMPLETED

    Beijing, 100730, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bengbu, 233004, China

  • Novartis Investigative Site

    COMPLETED

    Jinan, 250012, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shanghai, 200040, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shanghai, 200050, China

  • Novartis Investigative Site

    COMPLETED

    Shanghai, 200127, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Tianjin, 300052, China

  • Novartis Investigative Site

    COMPLETED

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    COMPLETED

    Chía, Cundinamarca, 250001, Colombia

  • Novartis Investigative Site

    COMPLETED

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    COMPLETED

    Ibague, Tolima Department, 730006, Colombia

  • Novartis Investigative Site

    RECRUITING

    Ostrava, Czech Republic, 772 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Brno-Zidonice, CZE, 61500, Czechia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Prague, Prague 1, 11000, Czechia

  • Novartis Investigative Site

    RECRUITING

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hradec Králové, 500 05, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 140 59, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 148 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    RECRUITING

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    WITHDRAWN

    Pátrai, Greece, 26443, Greece

  • Novartis Investigative Site

    COMPLETED

    Guatemala City, Departamento de Guatemala, 01010, Guatemala

  • Novartis Investigative Site

    COMPLETED

    Guatemala City, Departamento de Guatemala, 01011, Guatemala

  • Novartis Investigative Site

    COMPLETED

    Guatemala City, 01001, Guatemala

  • Novartis Investigative Site

    COMPLETED

    Guatemala City, 01009, Guatemala

  • Novartis Investigative Site

    COMPLETED

    Guatemala City, 01010, Guatemala

  • Novartis Investigative Site

    COMPLETED

    Surat, Gujarat, 395009, India

  • Novartis Investigative Site

    COMPLETED

    Bangalore, Karnataka, 560 079, India

  • Novartis Investigative Site

    COMPLETED

    Mumbai, Maharashtra, 400053, India

  • Novartis Investigative Site

    COMPLETED

    Nashik, Maharashtra, 422101, India

  • Novartis Investigative Site

    COMPLETED

    New Delhi, New Delhi, 110029, India

  • Novartis Investigative Site

    COMPLETED

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    COMPLETED

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    COMPLETED

    Reggio Emilia, RE, 42123, Italy

  • Novartis Investigative Site

    RECRUITING

    Ōme, Tokyo, 198-0042, Japan

  • Novartis Investigative Site

    COMPLETED

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    COMPLETED

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    COMPLETED

    Guadalajara, Jalisco, 44160, Mexico

  • Novartis Investigative Site

    COMPLETED

    Culiacan, State of Mexico, 80000, Mexico

  • Novartis Investigative Site

    COMPLETED

    Metepec, State of Mexico, 52140, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Novartis Investigative Site

    COMPLETED

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Warsaw, Poland, 02-637, Poland

  • Novartis Investigative Site

    COMPLETED

    Bialystok, 15-351, Poland

  • Novartis Investigative Site

    RECRUITING

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    RECRUITING

    Krakow, 30-002, Poland

  • Novartis Investigative Site

    COMPLETED

    Poznan, 60-218, Poland

  • Novartis Investigative Site

    COMPLETED

    Sochaczew, 96-500, Poland

  • Novartis Investigative Site

    RECRUITING

    Torun, 87-100, Poland

  • Novartis Investigative Site

    COMPLETED

    Warsaw, 02-118, Poland

  • Novartis Investigative Site

    COMPLETED

    Warsaw, 02-962, Poland

  • Novartis Investigative Site

    COMPLETED

    Warsaw, 04-305, Poland

  • Novartis Investigative Site

    COMPLETED

    Wroclaw, 53-224, Poland

  • Novartis Investigative Site

    COMPLETED

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    COMPLETED

    Barnaul, 656024, Russia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Chelyabinsk, 454048, Russia

  • Novartis Investigative Site

    COMPLETED

    Kazan', 420012, Russia

  • Novartis Investigative Site

    COMPLETED

    Kazan', 420064, Russia

  • Novartis Investigative Site

    COMPLETED

    Kemerovo, 650029, Russia

  • Novartis Investigative Site

    COMPLETED

    Kemerovo, 650070, Russia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Krasnodar, 350020, Russia

  • Novartis Investigative Site

    COMPLETED

    Moscow, 115522, Russia

  • Novartis Investigative Site

    COMPLETED

    Moscow, 119296, Russia

  • Novartis Investigative Site

    COMPLETED

    Moscow, 127473, Russia

  • Novartis Investigative Site

    COMPLETED

    Saint Petersburg, 190068, Russia

  • Novartis Investigative Site

    COMPLETED

    Saint Petersburg, 197022, Russia

  • Novartis Investigative Site

    COMPLETED

    Saint Petersburg, 197198, Russia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 197198, Russia

  • Novartis Investigative Site

    COMPLETED

    Saint Petersburg, 197341, Russia

  • Novartis Investigative Site

    COMPLETED

    Saratov, 410053, Russia

  • Novartis Investigative Site

    COMPLETED

    Smolensk, 214019, Russia

  • Novartis Investigative Site

    COMPLETED

    Ulyanovsk, 432063, Russia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yaroslavl, 150003, Russia

  • Novartis Investigative Site

    COMPLETED

    Yaroslavl, 150054, Russia

  • Novartis Investigative Site

    COMPLETED

    Yekaterinburg, 620023, Russia

  • Novartis Investigative Site

    COMPLETED

    Yekaterinburg, 620028, Russia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Panorama, Western Cape, 7500, South Africa

  • Novartis Investigative Site

    COMPLETED

    Stellenbosch, Western Cape, 7600, South Africa

  • Novartis Investigative Site

    COMPLETED

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    COMPLETED

    Seoul, Seoul, 06351, South Korea

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    COMPLETED

    Málaga, Andalusia, 29009, Spain

  • Novartis Investigative Site

    COMPLETED

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    COMPLETED

    Bilbao, Bizkaia, 48013, Spain

  • Novartis Investigative Site

    COMPLETED

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    COMPLETED

    Vigo, Pontevedra, 36214, Spain

  • Novartis Investigative Site

    COMPLETED

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    COMPLETED

    Madrid, 28009, Spain

  • Novartis Investigative Site

    COMPLETED

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28046, Spain

  • Novartis Investigative Site

    COMPLETED

    Madrid, 28046, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Seville, 41009, Spain

  • Novartis Investigative Site

    COMPLETED

    Valencia, 46026, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    COMPLETED

    Sankt Gallen, 9007, Switzerland

  • Oregon Health Sciences University

    COMPLETED

    Portland, Oregon, 97239, United States

  • Orrin Troum MD and Medical Associates

    COMPLETED

    Santa Monica, California, 90404, United States

  • Overlake Arthritis and Osteoporosis

    COMPLETED

    Bellevue, Washington, 98004, United States

  • Physician Research Collaboration

    COMPLETED

    Lincoln, Nebraska, 68516, United States

  • Precn Comprehensive Clnl Rsch Solns

    COMPLETED

    San Leandro, California, 94578, United States

  • Providence Medical Foundation

    COMPLETED

    Fullerton, California, 92835, United States

  • Purushotham Akther and Roshan Kotha MD Inc

    COMPLETED

    La Mesa, California, 91942, United States

  • Rheumatology Associates of South Florida

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Rheumatology Pulmonary Clinic

    COMPLETED

    Beckley, West Virginia, 25801, United States

  • Southwest Rheum Rsrch LLC

    COMPLETED

    Mesquite, Texas, 75150, United States

  • St Lawrence Health System

    COMPLETED

    Potsdam, New York, 13676, United States

  • West Tennessee Research Institute

    ACTIVE_NOT_RECRUITING

    Jackson, Tennessee, 38305, United States

  • Willow Rheumatology Wellness

    COMPLETED

    Willowbrook, Illinois, 60527, United States