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

Novartis

Status and phase: Active, not recruiting; Phase 4

Conditions: Non-radiographic Axial Spondyloarthritis

Treatments: Drug: Placebo; Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05622708

2023-509320-17-00 (Registry Identifier)

2022-001153-23 (EudraCT Number)

CAIN457I2401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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241 participants in 2 patient groups

Treatment Period 1

Experimental group

Description:

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

Treatment:

Drug: Secukinumab

Drug: Secukinumab

Treatment Period 2

Experimental group

Description:

Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo

Treatment:

Drug: Secukinumab

Drug: Placebo

Drug: Secukinumab