A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

Last updated: June 1, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Ankylosing Spondylitis

Treatment

Placebo

Secukinumab

Clinical Study ID

NCT05622708
CAIN457I2401
2022-001153-23
2023-509320-17-00
  • Ages 18-100
  • All Genders

Study Summary

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

Eligibility Criteria

Inclusion

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 centralreader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features

  • Objective signs of inflammation at screening, evident by either MRI with SacroiliacJoint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as definedby 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) atbaseline.

  • Participants should have been on at least 2 different NSAIDs (non-steroidalanti-inflammatory drugs) at the highest recommended dose for at least 4 weeks intotal prior to baseline with an inadequate response or failure to respond, or lessif therapy had to be withdrawn due to intolerance, toxicity or contraindications.

Exclusion

Exclusion Criteria:

  • Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally orgrade ≥ 3 unilaterally (radiological criterion according to the modified New Yorkdiagnostic 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-17or IL-17 receptor or previous treatment with immunomodulatory biologic agentsincluding those targeting TNFα (tumor necrosis factor α) (unless participantsdiscontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only afterappropriate wash-out period prior to baseline was observed).

  • History of hypersensitivity to the study drug or its excipients or to drugs ofsimilar chemical classes.

  • Active ongoing inflammatory diseases other than nr-axSpA that might confound theevaluation of the benefit of secukinumab therapy, including uveitis.

  • Active inflammatory bowel disease.

  • History of ongoing, chronic or recurrent infectious disease or evidence oftuberculosis infection.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
March 28, 2023
Estimated Completion Date:
April 04, 2028

Study Description

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with nr-axSpA who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

Study treatment will be as follows:

  • Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL

  • Double-blind Secukinumab and Placebo PFS will be labeled as AIN457 150mg/1mL/Placebo.

Study duration will be up to 128 weeks from Baseline.

The treatment duration will be up to 120 weeks with last treatment administration at Week 116.

In the Treatment Period 1 participant will attend a site visit approximately 1 month after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2 participant will attend site visits approximately every 4 weeks.

Connect with a study center

  • Novartis Investigative Site

    Bruges, 8000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Genk, 3600
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Ghent, 9000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Mons, 7000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais 36010 570
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul 90480-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Barretos, São Paulo 14784 400
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Bogota, Cundinamarca 110221
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Chía, Cundinamarca 250001
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Bucaramanga, Santander Department 680003
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Barranquilla, 080020
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Prague, 128 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Prague 3067696, 128 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Uherské Hradiště, 686 01
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170
    France

    Site Not Available

  • Novartis Investigative Site

    Le Mans, 72000
    France

    Site Not Available

  • Novartis Investigative Site

    Nice, 06001
    France

    Site Not Available

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    Orleans, 45067
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris, 75012
    France

    Site Not Available

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    Bad Doberan, 18209
    Germany

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  • Novartis Investigative Site

    Berlin, 13125
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin 2950159, 13125
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22415
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herne, 44649
    Germany

    Site Not Available

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    Ratingen, 40878
    Germany

    Site Not Available

  • Novartis Investigative Site

    Székesfehérvár, Fejér 8000
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye 4032
    Hungary

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  • Novartis Investigative Site

    Debrecen 721472, 4032
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Kistarcsa, 2143
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Miskolc, 3526
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, 6725
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged 715429, 6720
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Veszprém, 8200
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Haifa, 3339419
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Kfar Saba, 4428164
    Israel

    Site Not Available

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    Ramat Gan, 5265601
    Israel

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    Tel Aviv, 6423906
    Israel

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    Ancona, AN 60126
    Italy

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    Torino, TO 10128
    Italy

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    Negrar, VR 37024
    Italy

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  • Novartis Investigative Site

    Verona, VR 37126
    Italy

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  • Novartis Investigative Site

    Kuala Lumpur, 59100
    Malaysia

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  • Novartis Investigative Site

    Guadalajara, Jalisco 44690
    Mexico

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  • Novartis Investigative Site

    Guadalajara 4005539, Jalisco 4004156 44690
    Mexico

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  • Novartis Investigative Site

    Mérida, Yucatán 97070
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Chihuahua City, 31000
    Mexico

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  • Novartis Investigative Site

    Heerlen, Limburg 6419 PC
    Netherlands

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  • Novartis Investigative Site

    Amsterdam, North Holland 1105 AZ
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Makati City, National Capital Region 1218
    Philippines

    Site Not Available

  • Novartis Investigative Site

    Manila, 1008
    Philippines

    Site Not Available

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship 30-727
    Poland

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  • Novartis Investigative Site

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
    Poland

    Site Not Available

  • Novartis Investigative Site

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Novartis Investigative Site

    Bydgoszcz 3102014, 85 168
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Sochaczew, 96-500
    Poland

    Site Not Available

  • Novartis Investigative Site

    Torun, 87-100
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warsaw, 02-637
    Poland

    Site Not Available

  • Novartis Investigative Site

    Cluj-Napoca, Cluj 400006
    Romania

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  • Novartis Investigative Site

    Bucharest, 011055
    Romania

    Site Not Available

  • Novartis Investigative Site

    Bucharest 683506, 011172
    Romania

    Site Not Available

  • Novartis Investigative Site

    Cluj-Napoca 681290, 400006
    Romania

    Active - Recruiting

  • Novartis Investigative Site

    Bangkok, 10400
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Bangkok 1609350, 10400
    Thailand

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  • Novartis Investigative Site

    Adana, Yuregir 01230
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Konya, 42080
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Ho Chi Minh City, VNM 700000
    Vietnam

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  • Novartis Investigative Site

    Ho Chi Minh, 700000
    Vietnam

    Active - Recruiting

  • Novartis Investigative Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

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