Autoimmunity, InflammationPhase 4NCT04638647

Secukinumab Open Label Roll-over Extension Protocol

A Phase 4 study testing Secukinumab s.c. injection in people with Autoimmunity, Inflammation, run by Novartis Pharmaceuticals at 171 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation. Read more about this study

Who is it for?: Ages 6 to 100 years
Conditions the study is for: Autoimmunity, Inflammation
What is being tested?: Secukinumab s.c. injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 171 sitesin 20 countries
Study dates: 22 Dec 2020to 4 Apr 2030
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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).
Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
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).
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.
Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Who cannot join

Participant has prematurely discontinued study treatment in the parent protocol.
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).

Trial locations and contacts

171 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

Country

City, postcode or hospital

Sites recruiting now only

171 sites in 20 countries

China36 sites

Novartis Investigative Site
Baotou, Inner Mongolia, 014010
Active, not recruiting
Novartis Investigative Site
Beijing, Beijing Municipality, 100044
Active, not recruiting
Novartis Investigative Site
Beijing, 100000
Active, not recruiting
Novartis Investigative Site
Beijing, 100050
Completed
Novartis Investigative Site
Beijing, 100730
Completed
Novartis Investigative Site
Bengbu, 233004
Active, not recruiting
Novartis Investigative Site
Changchun, Jilin, 130021
Completed
Novartis Investigative Site
Changsha, Hunan, 410011
Active, not recruiting
Novartis Investigative Site
Chengdu, Sichuan, 610041
Completed
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010
Completed
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Completed
Novartis Investigative Site
Guangzhou, Guangdong, 510120
Completed
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Active, not recruiting
Novartis Investigative Site
Hefei, Anhui, 230001
Active, not recruiting
Novartis Investigative Site
Hefei, Anhui, 230601
Active, not recruiting
Novartis Investigative Site
Hohhot, Inner Mongolia, 010050
Completed
Novartis Investigative Site
Jinan, 250012
Completed
Novartis Investigative Site
Kunming, Yunnan, 650000
Active, not recruiting
Novartis Investigative Site
Linyi, Shandong, 276000
Active, not recruiting
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Completed
Novartis Investigative Site
Nanjing, Jiangsu, 210008
Active, not recruiting
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Active, not recruiting
Novartis Investigative Site
Ningbo, Zhejiang, 315016
Active, not recruiting
Novartis Investigative Site
Pingxiang, Jiangxi, 337000
Active, not recruiting
Novartis Investigative Site
Shanghai, 200001
Completed
Novartis Investigative Site
Shanghai, 200040
Active, not recruiting
Novartis Investigative Site
Shanghai, 200050
Active, not recruiting
Novartis Investigative Site
Shantou, Guangdong, 515000
Active, not recruiting
Novartis Investigative Site
Shenzhen, Guangdong, 518020
Active, not recruiting
Novartis Investigative Site
Tianjin, 300052
Active, not recruiting
Novartis Investigative Site
Ürümqi, Xinjiang, 830001
Active, not recruiting
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Active, not recruiting
Novartis Investigative Site
Wuhan, Hubei, 430030
Active, not recruiting
Novartis Investigative Site
Xiamen, Fujian, 361001
Active, not recruiting
Novartis Investigative Site
Yangzhou, Jiangsu, 225001
Active, not recruiting
Novartis Investigative Site
Zhuzhou, Hunan, 412000
Completed

Other trials in China

United States28 sites, 2 recruiting

Austin Regional Clinic Rheumatology
Austin, Texas, 78731
Completed
Rheumatology Pulmonary Clinic
Beckley, West Virginia, 25801
Completed
Overlake Arthritis and Osteoporosis
Bellevue, Washington, 98004
Completed
Rheumatology Associates of South Florida
Boca Raton, Florida, 33486
Heather Gliatta, +1 561 361 6547, Heathrah17@yahoo.com
Shawn Baca
Recruiting
Denver Arthritis Clinic
Denver, Colorado, 80230
Completed
Altoona Center for Clin Res
Duncansville, Pennsylvania, 16635
Active, not recruiting
Providence Medical Foundation
Fullerton, California, 92835
Completed
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439
Completed
Klein and Associates
Hagerstown, Maryland, 21740
Completed
Homestead Assoc In Research Inc
Homestead, Florida, 33033
Completed
Accurate Clinical Research Inc
Houston, Texas, 77089
Active, not recruiting
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256
Completed
West Tennessee Research Institute
Jackson, Tennessee, 38305
Active, not recruiting
Purushotham Akther and Roshan Kotha MD Inc
La Mesa, California, 91942
Completed
Physician Research Collaboration
Lincoln, Nebraska, 68516
Completed
Southwest Rheum Rsrch LLC
Mesquite, Texas, 75150
Completed
IRIS Research and Development
Plantation, Florida, 33324
Completed
Oregon Health Sciences University
Portland, Oregon, 97239
Completed
St Lawrence Health System
Potsdam, New York, 13676
Completed
Precn Comprehensive Clnl Rsch Solns
San Leandro, California, 94578
Completed
Orrin Troum MD and Medical Associates
Santa Monica, California, 90404
Completed
Inland Rheumatology Clinical Trials INC
Upland, California, 91786
Completed
Medvin Clinical Research
Van Nuys, California, 91405
Completed
Arthritis Rheumatology and Bone Disease Associates PA
Voorhees Township, New Jersey, 08043
Completed
Willow Rheumatology Wellness
Willowbrook, Illinois, 60527
Completed
Conquest Research
Winter Park, Florida, 32789
Completed
Center for Rheumatology Research
Woodland Hills, California, 91364
Completed
FL Medical Clinic Orlando Health
Zephyrhills, Florida, 33542
William Daily Johnston, +1 813 782 1234, william.johnston@orlandohealth.com
Natalie Faith
Recruiting

Other trials in United States

Russia22 sites

Novartis Investigative Site
Barnaul, 656024
Completed
Novartis Investigative Site
Chelyabinsk, 454048
Active, not recruiting
Novartis Investigative Site
Kazan', 420012
Completed
Novartis Investigative Site
Kazan', 420064
Completed
Novartis Investigative Site
Kemerovo, 650029
Completed
Novartis Investigative Site
Kemerovo, 650070
Completed
Novartis Investigative Site
Krasnodar, 350020
Active, not recruiting
Novartis Investigative Site
Moscow, 115522
Completed
Novartis Investigative Site
Moscow, 119296
Completed
Novartis Investigative Site
Moscow, 127473
Completed
Novartis Investigative Site
Saint Petersburg, 190068
Completed
Novartis Investigative Site
Saint Petersburg, 197022
Completed
Novartis Investigative Site
Saint Petersburg, 197198
Completed
Novartis Investigative Site
Saint Petersburg, 197198
Active, not recruiting
Novartis Investigative Site
Saint Petersburg, 197341
Completed
Novartis Investigative Site
Saratov, 410053
Completed
Novartis Investigative Site
Smolensk, 214019
Completed
Novartis Investigative Site
Ulyanovsk, 432063
Completed
Novartis Investigative Site
Yaroslavl, 150003
Active, not recruiting
Novartis Investigative Site
Yaroslavl, 150054
Completed
Novartis Investigative Site
Yekaterinburg, 620023
Completed
Novartis Investigative Site
Yekaterinburg, 620028
Completed

Other trials in Russia

Spain14 sites, 2 recruiting

Novartis Investigative Site
A Coruña, 15006
Completed
Novartis Investigative Site
Bilbao, Bizkaia, 48013
Completed
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Completed
Novartis Investigative Site
Madrid, 28009
Recruiting
Novartis Investigative Site
Madrid, 28009
Completed
Novartis Investigative Site
Madrid, 28041
Completed
Novartis Investigative Site
Madrid, 28046
Recruiting
Novartis Investigative Site
Madrid, 28046
Completed
Novartis Investigative Site
Málaga, Andalusia, 29009
Completed
Novartis Investigative Site
Santander, Cantabria, 39008
Completed
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Active, not recruiting
Novartis Investigative Site
Seville, 41009
Withdrawn
Novartis Investigative Site
Valencia, 46026
Completed
Novartis Investigative Site
Vigo, Pontevedra, 36214
Completed

Other trials in Spain

Poland13 sites, 3 recruiting

Novartis Investigative Site
Bialystok, 15-351
Completed
Novartis Investigative Site
Bydgoszcz, 85-168
Recruiting
Novartis Investigative Site
Krakow, Lesser Poland Voivodeship, 30-727
Active, not recruiting
Novartis Investigative Site
Krakow, 30-002
Recruiting
Novartis Investigative Site
Poznan, 60-218
Completed
Novartis Investigative Site
Sochaczew, 96-500
Completed
Novartis Investigative Site
Torun, 87-100
Recruiting
Novartis Investigative Site
Warsaw, Poland, 02-637
Active, not recruiting
Novartis Investigative Site
Warsaw, 02-118
Completed
Novartis Investigative Site
Warsaw, 02-962
Completed
Novartis Investigative Site
Warsaw, 04-305
Completed
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 52-210
Completed
Novartis Investigative Site
Wroclaw, 53-224
Completed

Other trials in Poland

Czechia10 sites, 8 recruiting

Novartis Investigative Site
Brno, 625 00
Recruiting
Novartis Investigative Site
Brno-Zidonice, CZE, 615 00
Recruiting
Novartis Investigative Site
Hradec Králové, 500 05
Active, not recruiting
Novartis Investigative Site
Ostrava, Czech Republic, 772 00
Recruiting
Novartis Investigative Site
Prague, 110 00
Active, not recruiting
Novartis Investigative Site
Prague, 128 00
Recruiting
Novartis Investigative Site
Prague, 140 59
Recruiting
Novartis Investigative Site
Prague, 148 00
Recruiting
Novartis Investigative Site
Prague, 150 06
Recruiting
Novartis Investigative Site
Uherské Hradiště, 686 01
Recruiting

Other trials in Czechia

Brazil7 sites

Novartis Investigative Site
Juiz de Fora, Minas Gerais, 36010-570
Completed
Novartis Investigative Site
Rio de Janeiro, 20241-180
Completed
Novartis Investigative Site
Salvador, Estado de Bahia, 40150-150
Completed
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000
Completed
Novartis Investigative Site
São Paulo, São Paulo, 01244-030
Completed
Novartis Investigative Site
São Paulo, São Paulo, 04266-010
Completed
Novartis Investigative Site
Vitória, Espírito Santo, 29055-450
Completed

Other trials in Brazil

Bulgaria6 sites

Novartis Investigative Site
Pleven, 5800
Active, not recruiting
Novartis Investigative Site
Plovdiv, Bulgaria, 4002
Completed
Novartis Investigative Site
Sofia, Bulgaria, 1407
Active, not recruiting
Novartis Investigative Site
Sofia, 1431
Completed
Novartis Investigative Site
Sofia, 1784
Completed
Novartis Investigative Site
Stara Zagora, Bulgaria, 6000
Active, not recruiting

Other trials in Bulgaria

India6 sites

Novartis Investigative Site
Bangalore, Karnataka, 560079
Completed
Novartis Investigative Site
Hyderabad, Telangana, 500082
Completed
Novartis Investigative Site
Mumbai, Maharashtra, 400053
Completed
Novartis Investigative Site
Nashik, Maharashtra, 422101
Completed
Novartis Investigative Site
New Delhi, New Delhi, 110029
Completed
Novartis Investigative Site
Surat, Gujarat, 395009
Completed

Other trials in India

Guatemala5 sites

Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
Completed
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01011
Completed
Novartis Investigative Site
Guatemala City, 01001
Completed
Novartis Investigative Site
Guatemala City, 01009
Completed
Novartis Investigative Site
Guatemala City, 01010
Completed

Other trials in Guatemala

Colombia4 sites

Novartis Investigative Site
Bogota, Cundinamarca, 110221
Completed
Novartis Investigative Site
Bucaramanga, Santander Department, 680003
Completed
Novartis Investigative Site
Chía, Cundinamarca, 250001
Completed
Novartis Investigative Site
Ibague, Tolima Department, 730006
Completed

Other trials in Colombia

Japan4 sites, 2 recruiting

Novartis Investigative Site
Asahikawa, Hokkaido, 0708644
Recruiting
Novartis Investigative Site
Fuchū, Tokyo, 1838524
Active, not recruiting
Novartis Investigative Site
Okayama, 7008607
Recruiting
Novartis Investigative Site
Ōme, Tokyo, 1980042
Active, not recruiting

Other trials in Japan

Mexico3 sites

Novartis Investigative Site
Culiacan, State of Mexico, 80000
Completed
Novartis Investigative Site
Guadalajara, Jalisco, 44160
Completed
Novartis Investigative Site
Metepec, State of Mexico, 52140
Completed

Other trials in Mexico

Switzerland3 sites

Novartis Investigative Site
Basel, 4031
Active, not recruiting
Novartis Investigative Site
Bern, 3010
Active, not recruiting
Novartis Investigative Site
Sankt Gallen, 9007
Completed

Other trials in Switzerland

Italy2 sites

Novartis Investigative Site
Florence, FI, 50134
Completed
Novartis Investigative Site
Reggio Emilia, RE, 42123
Completed

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Malaysia2 sites

Novartis Investigative Site
Kuala Lumpur, 59100
Completed
Novartis Investigative Site
Kuching, Sarawak, 93586
Completed

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South Africa2 sites

Novartis Investigative Site
Panorama, Western Cape, 7500
Active, not recruiting
Novartis Investigative Site
Stellenbosch, Western Cape, 7600
Completed

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South Korea2 sites

Novartis Investigative Site
Seoul, Seoul, 03080
Completed
Novartis Investigative Site
Seoul, Seoul, 06351
Completed

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Greece1 site

Novartis Investigative Site
Pátrai, Greece, 264 43
Withdrawn

Other trials in Greece

Portugal1 site

Novartis Investigative Site
Lisbon, 1649-035
Completed

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About this study

Official title: An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment

Conditions: Autoimmunity, Inflammation
Being tested: Secukinumab s.c. injection
Keywords: Secukinumab, Post trial access
Medical subject headings: Autoimmune Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Secukinumab s.c. injectionBiological
Secukinumab pre-filled syringes (PFS) for s.c. injection

Study groups in NCT04638647
Study group	Role	What they receive
Secukinumab s.c.	Experimental	Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol. Receives: Biological: Secukinumab s.c. injection

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate long term safety as assessed by occurrence of AEs/SAEs
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 20204 Apr 2030

First posted20 Nov 2020
Study start22 Dec 2020
Primary completion29 Jan 2030 (estimated)
Study completion4 Apr 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Autoimmunity, InflammationStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04638647
Sponsor's protocol ID: CAIN457A02001B
Other IDs: 2023-504417-67-00, 2023
Status last verified: Oct 2026
First submitted: 16 Nov 2020
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Interested in taking part?

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitation
Nutrition in Rheumatoid Arthritis
Rheumatoid Arthritis (RA)
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome

All Autoimmunity, Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment
ClinicalTrials.gov ID: NCT04638647
Acronym / sponsor ID: CAIN457A02001B
Conditions: Autoimmunity, Inflammation
Keywords: Secukinumab, Post trial access
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,000 participants (estimated)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 22 Dec 2020 (actual)
Primary completion: 29 Jan 2030 (estimated)
Study completion: 4 Apr 2030 (estimated)
First posted: 20 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Secukinumab s.c.	Experimental	Biological: Secukinumab s.c. injectionParticipants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.

Who may qualify

Ages: 6 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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).
Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
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).
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.
Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Key exclusion criteria (2 listed)

Participant has prematurely discontinued study treatment in the parent protocol.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Secukinumab s.c. injectionSecukinumab pre-filled syringes (PFS) for s.c. injection	Biological	Secukinumab s.c.

Primary outcome

To evaluate long term safety as assessed by occurrence of AEs/SAEs
Time frame: up to 2 years
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Related trials for Autoimmunity, Inflammation

Enrolling by invitation
Nutrition in Rheumatoid Arthritis
Rheumatoid Arthritis (RA)
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

171 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab s.c. injection in people with Autoimmunity, Inflammation, run by Novartis Pharmaceuticals at 171 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in China, United States, Russia, Spain, Poland and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate long term safety as assessed by occurrence of AEs/SAEs (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638647.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.