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

Last updated: March 5, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Ankylosing Spondylitis

Treatment

Placebo

Secukinumab

Clinical Study ID

NCT05622708
CAIN457I2401
2023-509320-17-00
2022-001153-23
  • 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least 4 weeks intotal prior to baseline with an inadequate response or failure to respond, or lessif therapy had to be withdrawn due to intolerance, toxicity or contraindications.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: 340
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
March 28, 2023
Estimated Completion Date:
June 21, 2030

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.

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