Study of Secukinumab for Maintaining Remission in Patients with Non-Radiographic Axial Spondyloarthritis

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What is this study about?

This clinical trial investigates the treatment of non-radiographic axial spondyloarthritis, a condition that causes inflammation and pain in the spine and pelvis. The study involves the use of secukinumab, an injection that helps reduce inflammation by targeting specific proteins in the immune system. The study will also involve a group of participants receiving a placebo for comparison.

The purpose of this clinical trial is to find out if continuous treatment with secukinumab is better than a placebo at preventing flare-ups in people who have already seen improvement from the treatment. Participants who have reached a state of remission, meaning their symptoms have improved significantly, will either continue with secukinumab or switch to a placebo to see how well the improvements last over time.

Participants will be randomly assigned to either continue receiving secukinumab or switch to a placebo in a process called “double-blind,” meaning neither the participants nor the researchers know who is receiving which treatment. This helps ensure that the study results are unbiased. The study aims to maintain the positive effects of the treatment and observe how many participants remain flare-free over the study period.

1 initial treatment period

Participants receive secukinumab or a placebo through subcutaneous injection. The dosage is 150 mg per 1 mL solution, administered using a pre-filled syringe.

The goal is to achieve remission of non-radiographic axial spondyloarthritis, a condition characterized by inflammation of the spine and sacroiliac joints.

2 evaluation of remission

Participants are assessed to determine if they have achieved remission. Remission is defined by the absence of significant symptoms and inflammation.

This evaluation is crucial to decide if participants can proceed to the next phase of the trial.

3 randomized withdrawal-retreatment period

Participants who achieve remission enter a double-blind, placebo-controlled phase. This means neither the participants nor the researchers know who receives the active drug or placebo.

The objective is to evaluate if continuous treatment with secukinumab is more effective than placebo in preventing symptom flares.

4 monitoring and assessment

Participants are monitored for flares, which are episodes of increased disease activity. The primary endpoint is the proportion of participants who remain flare-free at Week 120.

Secondary assessments include the time to flare and the safety and tolerability of the treatment, evaluated through adverse events and changes in laboratory parameters and vital signs.

5 completion of trial

The trial is estimated to end by June 19, 2030. Participants’ data will contribute to understanding the long-term effectiveness and safety of secukinumab in maintaining remission.

Who Can Join the Study?

  • Participants must be male or non-pregnant, non-lactating female and at least 18 years old.
  • Must have a clinical diagnosis of a condition called axSpA (axial spondyloarthritis) and meet specific criteria:
    • Have had inflammatory back pain for at least 6 months.
    • The pain must have started before the age of 45.
    • Must show signs of sacroiliitis (inflammation in the lower back) on an MRI scan or have a positive HLA-B-27 test with at least two features of SpA (spondyloarthritis).
  • Must show objective signs of inflammation at the start of the study, which can be seen through:
    • An MRI scan showing inflammation in the sacroiliac joint.
    • Or a blood test showing hsCRP (a marker of inflammation) higher than normal.
  • Must have active axSpA, which means a score of 4 or more on a scale called BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) at the start of the study.
  • Must have spinal pain with a score of 4 or more on a specific question in the BASDAI at the start of the study.
  • Must have total back pain with a score of 40 or more on a scale called VAS (Visual Analogue Scale) at the start of the study.
  • Must have tried at least two different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks before the study, without adequate relief, or had to stop due to side effects or other reasons.

Who Cannot Join the Study?

  • Participants with radiographic evidence of sacroiliitis, which is inflammation in the joints where the lower spine and pelvis connect. Specifically, they cannot have a grade 2 or higher on both sides, or grade 3 or higher on one side as assessed by a central reader.
  • Participants taking high potency opioid analgesics, which are strong pain-relieving medications like methadone, hydromorphone, or morphine.
  • Participants who have previously been treated with secukinumab or any other biologic drugs that directly target IL-17 or its receptor. This also includes other biologic treatments that alter the immune system, especially those targeting TNFα (tumor necrosis factor alpha), unless they stopped for reasons other than not working effectively.
  • Participants with a history of hypersensitivity, which is a severe allergic reaction, to the study drug or its excipients (inactive ingredients) or to drugs from similar chemical classes.
  • Participants with active ongoing inflammatory diseases other than non-radiographic axial spondyloarthritis (nr-axSpA) that could interfere with evaluating the benefits of the study drug. This includes conditions like uveitis, which is inflammation in the eye.
  • Participants with active inflammatory bowel disease, which is a condition involving chronic inflammation of the digestive tract.
  • Participants with a history of ongoing, chronic or recurrent infectious diseases, or evidence of having tuberculosis infection, which is a serious infectious disease affecting the lungs and sometimes other parts of the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Zuyderland Medisch Centrum Stichting Geleen The Netherlands

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Le Mans Le Mans France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
CHU Helora La Louviere Belgium
Rcmed Oddzial Sochaczew Sochaczew Poland
Rheumatologische Schwerpunktpraxis Berlin Germany
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Rujxqztacnflic Ubxaw Prague Czechia
Msfqngmmi Iwapnyvpra Cmrvnagk Sczvjifl Sgi z oucf Warsaw Poland
Uentpfnybx Og Daamusdd Debrecen Hungary
Fceddrsp nwzemisey Mrbmv a Hfkvjmd Prague Czechia
Axjdhtbjw Uss Amsterdam The Netherlands
Ultfxourneugoepkf Duxfd Sfjhz Da Vgwcsb Verona Italy
Clqqczs Uvgfbaogrnyvzopmwhiu Bqehiz Ksy Berlin Germany
Ctfvso Hrvjzuxwtlx Rajsjsdg Uadvzrdenivzy Da Tpnbp Tours France
Uhbourtnjhpnmsdmi Pgwroglfwnb Drzru Mmgfth Ancona Italy
Bxxpfutavubhnoadgtxd Vljutmwar Kbbdhmjna Kwmnmb Et Edhprzdm Oviguxifhjtw Miskolc Hungary
Uedqnznsgl Om Syamyx Szeged Hungary
Uizwdhohet Hxpzqigf Msrslxxwcy Maastricht The Netherlands
Ulceakqyby Degvp Splaa Dp Rhvd Lm Sdprrdai Rome Italy
Uqwiyzjuclov Zugkuuqbhx Gccr Gent Belgium
Cnympsw Miyrojz Dj Dkypqkamfq Sm Tvaqwhgam Apbpmktpd Nolguv Sxidhx Brasov Romania
Snyrwtr Uxiloucosqqxr Nb 2 Ie Du Jwyk Bxguozh W Bnedhnzfcu Bydgoszcz Poland
Hminpdx Siadq Aqfrsqr Paris France
Nevyndlq Innqvhbr Gjnxxijrv Rdlunilfhfjh I Rfayapvamabqn In Pwcbl Du Hxuv Mrft Emfkbjpc Rqrfeur Warsaw Poland
Alnbhzi Plucx sglcwa Prague Czechia
Kjbtdweueu Fome Fnzwyg Kisodb Kistarcsa Hungary
Bonxtibxoz Ivdhmcysnfvf Bzols Iwfzqwpbhfdqq Khltdn Budapest Hungary
Ercbdlx Gkyfd Sjxdls Scheia Romania
Iopxl Odlkqzng Sqomw Cwgux Dkb Cjjaiujg Negrar di Valpolicella Italy
Crgppz Hxyoamyolwu Uikntbehtuxzd deuecygtx Orléans France
Asnoqzg Oljliroaohi Uiudvrbzvblew Sckatb Siena Italy
Putnrq Sple Skorzewo Poland
Sfocuvfi Clofcl Jpeapesb Ds Uiabmam Stavy Sibiu Romania
Sit Edttkuilm Gnsszz Gano Ktbbtbcqtni Kxolnxis Rkbtntwdem Herne Germany
Immhlropxcnhipigpmgj Gmte Berlin Germany
Ipzgyvts Oxbjvhlqse Rxjdqpm Bologna Italy
Sqyae Myllo Hauinyii Bucharest Romania
Kohmtcvv dmm Sbhnw Lwprtynkoifw al Rwkfh gjxym Ludwigshafen Am Rhein Germany
Alck Chyefk Sizcmydtfbbrv Ookynpsjdb Tccblyyrbznlpu Glpawze Pkrp Crm Milan Italy
Ikdmlumu Ftqo Ptllvzrnqul Mtqcfct &wqvc Kewtyvcij Ftwdcrrvv Gjg Magdeburg Germany
Mwfqwrm Plja svjopu Uherske Hradiste Czechia
Mcoysuvhoqx Beaduvr Kjjtrvaca Spm z oqro Cracow Poland
Rfwlnapzias Genk Belgium
Auveqko Oorfqhucduu Oyrtbb Mdqvzwgvkn Dr Tgmmqq Turin Italy
Bksusvic Bnrqwaxykaialrb Fieuejjjo ugo Eeyxbynoyke Gpps Bad Doberan Germany
Maamxmdx Shsvwg Bucharest Romania
Vekhxdtmwlxzwz Kpbn Veszprem Hungary
Ppczmp fyl kmxepgivx Sdbekbf Hamburg Germany
Nksj &girulsfzshwhncgnpbyjdluf sxay Aotml Rrdzasqck Jrtvt Sbrvnrxt Bialystok Poland
Rypqiqtwwgvecdfa Spqrqqypqpiftwiwo Rnudnrzez Rendsburg Germany
Rpejveigdldnd Rfhganqg Ratingen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
27.03.2023
Czechia Czechia
Not recruiting
27.03.2023
France France
Not recruiting
27.03.2023
Germany Germany
Not recruiting
27.03.2023
Hungary Hungary
Not recruiting
27.03.2023
Italy Italy
Not recruiting
27.03.2023
Poland Poland
Not recruiting
27.03.2023
Romania Romania
Not recruiting
27.03.2023
The Netherlands The Netherlands
Not recruiting
27.03.2023

Trial locations

Investigated Drugs:

Secukinumab is a medication used in this clinical trial to help manage symptoms in people with non-radiographic axial spondyloarthritis. It works by targeting specific proteins in the body that cause inflammation, helping to reduce pain and swelling. The trial aims to see if continuing treatment with secukinumab can prevent the return of symptoms in patients who have already achieved remission.

Non-radiographic axial spondyloarthritis – This is a type of inflammatory arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. Unlike other forms of spondyloarthritis, it does not show visible damage on standard X-rays, which can make it harder to diagnose. The disease often begins with pain and stiffness in the lower back and buttocks, especially in the morning or after periods of inactivity. Over time, the inflammation can lead to reduced flexibility and mobility in the spine. Symptoms may also include fatigue and, in some cases, inflammation in other parts of the body, such as the eyes or intestines. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe challenges.

Trial ID:
2023-509320-17-00
Protocol code:
CAIN457I2401
NCT ID:
NCT05622708
Trial Phase:
Therapeutic confirmatory (Phase III)

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