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

A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-radiographic Axial Spondyloarthritis
• Intervention / Treatment: Drug: Secukinumab; Drug: Secukinumab; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium, 8000
    • Novartis Investigative Site
  • Genk, Belgium, 3600
    • Novartis Investigative Site
  • Ghent, Belgium, 9000
    • Novartis Investigative Site
  • Mons, Belgium, 7000
    • Novartis Investigative Site
• Brazil
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36010 570
      • Novartis Investigative Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
      • Novartis Investigative Site
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784 400
      • Novartis Investigative Site
• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Novartis Investigative Site
    • Bogota, Cundinamarca, Colombia, 110111
      • Novartis Investigative Site
    • Chía, Cundinamarca, Colombia, 250001
      • Novartis Investigative Site
  • Santander Department
    • Bucaramanga, Santander Department, Colombia, 680003
      • Novartis Investigative Site
• Czechia
  • Prague, Czechia, 150 06
    • Novartis Investigative Site
  • Prague, Czechia, 128 00
    • Novartis Investigative Site
  • Prague, Czechia, 148 00
    • Novartis Investigative Site
  • Uherské Hradiště, Czechia, 686 01
    • Novartis Investigative Site
• France
  • Chambray-lès-Tours, France, 37170
    • Novartis Investigative Site
  • Le Mans, France, 72000
    • Novartis Investigative Site
  • Nice, France, 06001
    • Novartis Investigative Site
  • Paris, France, 75012
    • Novartis Investigative Site
• Germany
  • Bad Doberan, Germany, 18209
    • Novartis Investigative Site
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Berlin, Germany, 12161
    • Novartis Investigative Site
  • Hamburg, Germany, 22415
    • Novartis Investigative Site
  • Herne, Germany, 44649
    • Novartis Investigative Site
  • Ratingen, Germany, 40878
    • Novartis Investigative Site
• Hungary
  • Kistarcsa, Hungary, 2143
    • Novartis Investigative Site
  • Miskolc, Hungary, 3526
    • Novartis Investigative Site
  • Szeged, Hungary, 6725
    • Novartis Investigative Site
  • Veszprém, Hungary, 8200
    • Novartis Investigative Site
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Novartis Investigative Site
  • Hajdu Bihar Megye
    • Debrecen, Hajdu Bihar Megye, Hungary, 4032
      • Novartis Investigative Site
• Israel
  • Kfar Saba, Israel, 4428164
    • Novartis Investigative Site
  • Ramat Gan, Israel, 5265601
    • Novartis Investigative Site
  • Tel Aviv, Israel, 6423906
    • Novartis Investigative Site
• Italy
  • AN
    • Ancona, AN, Italy, 60126
      • Novartis Investigative Site
  • TO
    • Torino, TO, Italy, 10128
      • Novartis Investigative Site
  • VR
    • Negrar, VR, Italy, 37024
      • Novartis Investigative Site
    • Verona, VR, Italy, 37126
      • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Novartis Investigative Site
• Mexico
  • Chihuahua City, Mexico, 31000
    • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44690
      • Novartis Investigative Site
    • Guadalajara, Jalisco, Mexico, 44650
      • Novartis Investigative Site
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Novartis Investigative Site
• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Novartis Investigative Site
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Novartis Investigative Site
• Philippines
  • Manila, Philippines, 1008
    • Novartis Investigative Site
  • National Capital Region
    • Makati City, National Capital Region, Philippines, 1218
      • Novartis Investigative Site
• Poland
  • Bydgoszcz, Poland, 85-168
    • Novartis Investigative Site
  • Krakow, Poland, 30-002
    • Novartis Investigative Site
  • Sochaczew, Poland, 96-500
    • Novartis Investigative Site
  • Torun, Poland, 87-100
    • Novartis Investigative Site
  • Warsaw, Poland, 02-637
    • Novartis Investigative Site
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-727
      • Novartis Investigative Site
• Romania
  • Bucharest, Romania, 011055
    • Novartis Investigative Site
  • Bucharest, Romania, 011172
    • Novartis Investigative Site
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
• Turkey (Türkiye)
  • Konya, Turkey (Türkiye), 42080
    • Novartis Investigative Site
  • Yuregir
    • Adana, Yuregir, Turkey (Türkiye), 01230
      • Novartis Investigative Site
• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Novartis Investigative Site
  • VNM
    • Ho Chi Minh City, VNM, Vietnam, 700000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Period 1; Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL	Drug: Secukinumab; Treatment Period 1: Open-label secukinumab 150 mg PFS s.c. at baseline, Weeks 1, 2, 3 and 4 followed by administration every four weeks up to Week 52.; Drug: Secukinumab; Treatment Period 2: Double-blind secukinumab 150 mg PFS s.c. every 4 weeks from Week 56 to Week 116. Escape re-treatment (during Treatment Period 2): Open-label secukinumab 150 mg PFS s.c.
Experimental: Treatment Period 2; Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo	Drug: Secukinumab; Treatment Period 1: Open-label secukinumab 150 mg PFS s.c. at baseline, Weeks 1, 2, 3 and 4 followed by administration every four weeks up to Week 52.; Drug: Secukinumab; Treatment Period 2: Double-blind secukinumab 150 mg PFS s.c. every 4 weeks from Week 56 to Week 116. Escape re-treatment (during Treatment Period 2): Open-label secukinumab 150 mg PFS s.c.; Drug: Placebo; Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants remaining flare-free during Treatment Period 2	The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60. Parameters used for ASDAS-CRP include: Spinal pain (BASDAI question 2),; Patient's global assessment of disease activity,; Peripheral pain/swelling (BASDAI question 3),; Duration of morning stiffness (BASDAI question 6); C-reactive protein (CRP) in mg/L	Week 120

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to flare during Treatment Period 2	A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60.	From Week 56 to Week 120
Number of participants with Adverse Events	Safety and tolerability demonstrated by assessing: - Adverse events (AEs) and serious adverse events (SAEs)	From Baseline to Week 128

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): February 8, 2028
• Study Completion (Estimated): April 4, 2028

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: remission; nr-AxSpa; non-radiographic axial Spondyloarthritis; Secukinumab; withdrawal; inflammatory back pain; sacroiliitis; AIN457
• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Non-Radiographic Axial Spondyloarthritis; Sacroiliitis; Immunologic Factors; Physiological Effects of Drugs; secukinumab
• Other Study ID Numbers: CAIN457I2401; 2022-001153-23 (EudraCT Number); 2023-509320-17-00 (Registry Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No