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Can a drug keep arthritis in remission? new study seeks answers

NCT ID NCT05622708

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study looks at whether people with a type of spinal arthritis (non-radiographic axial spondyloarthritis) who are in remission need to keep taking secukinumab to avoid flare-ups. About 240 adults with confirmed inflammation will either continue the drug or switch to a placebo. The main goal is to see how many stay flare-free for 120 weeks.

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

240 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Apr 2028

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

18 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: * Male or non-pregnant, non-lactating female participants at least 18 years of age * Clinical diagnosis of axSpA AND according to ASAS axSpA criteria: 1. Inflammatory back pain for at least 6 months 2. Onset before 45 years of age 3. Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features * Objective signs of inflammation at screening, evident by either MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR hsCRP \> ULN (as defined by the central lab) * Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline. * Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline. * Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at baseline. * Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications. Exclusion Criteria: * Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader. * Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine). * Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy \[primary or secondary lack of efficacy, inadequate response\] and only after appropriate wash-out period prior to baseline was observed). * History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes. * Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis. * Active inflammatory bowel disease. * History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.

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Conditions

The condition(s) this trial relates to.

Non-Radiographic Axial Spondyloarthritis Sacroiliitis spondyloarthropathy

As listed by the trial registrant

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

Non-radiographic axial spondyloarthritis

Contacts and locations

Locations

  • Novartis Investigative Site

    Genk, Belgium, 3600, Belgium

  • Novartis Investigative Site

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Mons, 7000, Belgium

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400, Brazil

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110111, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    Chía, Cundinamarca, 250001, Colombia

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Prague, 148 00, Czechia

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Nice, 06000, France

  • Novartis Investigative Site

    Paris, 75012, France

  • Novartis Investigative Site

    Bad Doberan, 18209, Germany

  • Novartis Investigative Site

    Berlin, 10777, Germany

  • Novartis Investigative Site

    Berlin, 13125, Germany

  • Novartis Investigative Site

    Hamburg, 22415, Germany

  • Novartis Investigative Site

    Herne, 44649, Germany

  • Novartis Investigative Site

    Ratingen, 40878, Germany

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Kistarcsa, 2143, Hungary

  • Novartis Investigative Site

    Miskolc, 3526, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Veszprém, 8200, Hungary

  • Novartis Investigative Site

    Kfar Saba, 4428164, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Torino, TO, 10128, Italy

  • Novartis Investigative Site

    Negrar, VR, 37024, Italy

  • Novartis Investigative Site

    Verona, VR, 37126, Italy

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Chihuahua City, Chihuahua, 31000, Mexico

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650, Mexico

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44690, Mexico

  • Novartis Investigative Site

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    Heerlen, Limburg, 6419 PC, Netherlands

  • Novartis Investigative Site

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Novartis Investigative Site

    Makati City, National Capital Region, 1218, Philippines

  • Novartis Investigative Site

    Manila, 1008, Philippines

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Novartis Investigative Site

    Warsaw, Poland, 02-637, Poland

  • Novartis Investigative Site

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    Krakow, 30-002, Poland

  • Novartis Investigative Site

    Sochaczew, 96-500, Poland

  • Novartis Investigative Site

    Torun, 87-100, Poland

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006, Romania

  • Novartis Investigative Site

    Bucharest, 011055, Romania

  • Novartis Investigative Site

    Bucharest, 011172, Romania

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Adana, Yuregir, 01230, Turkey (Türkiye)

  • Novartis Investigative Site

    Konya, 42080, Turkey (Türkiye)

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 700000, Vietnam

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