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

NCT05622708 | Active Not Recruiting Phase 4

• 3 other identifiers: CAIN457I24012022-001153-232023-509320-17-00
• Study Type: interventional
• Target: 240
• Locations: 18 countries
• Sites: 63

Brief 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.

Conditions

Non-radiographic Axial Spondyloarthritis

Keywords

nr-AxSpa; non-radiographic axial Spondyloarthritis; Secukinumab; remission; withdrawal; inflammatory back pain; sacroiliitis; AIN457

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to flare during Treatment Period 2

  From Week 56 to Week 120

• Number of participants with Adverse Events

  From Baseline to Week 128

Study Arms (2)

Treatment Period 1

EXPERIMENTAL

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

Drug: Secukinumab

Treatment Period 2

EXPERIMENTAL

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

Drug: Placebo; Drug: Secukinumab

Interventions

Placebo DRUG

Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.

Treatment Period 2

Secukinumab DRUG

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.

Treatment Period 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female participants at least 18 years of age
• Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
• Inflammatory back pain for at least 6 months
• Onset before 45 years of age
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (63)

Novartis Investigative Site

Bruges, 8000, Belgium

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Novartis Investigative Site

Genk, 3600, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Mons, 7000, Belgium

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Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil

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Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

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Novartis Investigative Site

Barretos, São Paulo, 14784 400, Brazil

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Novartis Investigative Site

Bogota, Cundinamarca, 110111, Colombia

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Novartis Investigative Site

Bogota, Cundinamarca, 110221, Colombia

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Novartis Investigative Site

Chía, Cundinamarca, 250001, Colombia

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Novartis Investigative Site

Bucaramanga, Santander Department, 680003, Colombia

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Novartis Investigative Site

Prague, 128 00, Czechia

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Novartis Investigative Site

Prague, 148 00, Czechia

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Novartis Investigative Site

Prague, 150 06, Czechia

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Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

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Novartis Investigative Site

Chambray-lès-Tours, 37170, France

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Novartis Investigative Site

Le Mans, 72000, France

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Novartis Investigative Site

Nice, 06001, France

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Novartis Investigative Site

Paris, 75012, France

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Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Novartis Investigative Site

Bad Doberan, 18209, Germany

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Novartis Investigative Site

Berlin, 12161, Germany

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Novartis Investigative Site

Berlin, 13125, Germany

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Novartis Investigative Site

Hamburg, 22415, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Ratingen, 40878, Germany

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Novartis Investigative Site

Székesfehérvár, Fejér, 8000, Hungary

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Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

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Novartis Investigative Site

Kistarcsa, 2143, Hungary

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Novartis Investigative Site

Miskolc, 3526, Hungary

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Novartis Investigative Site

Szeged, 6725, Hungary

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Novartis Investigative Site

Veszprém, 8200, Hungary

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Novartis Investigative Site

Kfar Saba, 4428164, Israel

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Novartis Investigative Site

Ramat Gan, 5265601, Israel

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Novartis Investigative Site

Tel Aviv, 6423906, Israel

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Torino, TO, 10128, Italy

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Novartis Investigative Site

Negrar, VR, 37024, Italy

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Novartis Investigative Site

Verona, VR, 3712, Italy

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Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

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Novartis Investigative Site

Guadalajara, Jalisco, 44650, Mexico

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Novartis Investigative Site

Guadalajara, Jalisco, 44690, Mexico

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Novartis Investigative Site

Mérida, Yucatán, 97070, Mexico

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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

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Novartis Investigative Site

Makati City, National Capital Region, 1218, Philippines

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Novartis Investigative Site

Manila, 1008, Philippines

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Novartis Investigative Site

Krakow, Lesser Poland Voivodeship, 30-727, Poland

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Novartis Investigative Site

Bydgoszcz, 85-168, Poland

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Novartis Investigative Site

Krakow, 30-002, Poland

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Novartis Investigative Site

Sochaczew, 96-500, Poland

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Novartis Investigative Site

Torun, 87-100, Poland

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Novartis Investigative Site

Warsaw, 02-637, Poland

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Novartis Investigative Site

Cluj-Napoca, Cluj, 400006, Romania

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Novartis Investigative Site

Bucharest, 011055, Romania

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Novartis Investigative Site

Bucharest, 011172, Romania

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Novartis Investigative Site

Bangkok, 10400, Thailand

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Novartis Investigative Site

Bangkok, 10700, 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 City, 700000, Vietnam

Location

MeSH Terms

Conditions

Non-Radiographic Axial Spondyloarthritis; Sacroiliitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This phase IV, multicenter study uses a double-blind, placebo-controlled, randomized withdrawal design (Treatment Period 2) preceded by an open label lead-in period (Treatment Period 1).

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 21, 2022
• Study Start: March 28, 2023
• Primary Completion (Estimated): April 19, 2028
• Study Completion (Estimated): June 13, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (4); TU (2); HU (6); DE (7); MY (1); ME (4); TH (2); IL (3); NL (2); PL (6); VN (2); PH (2); BE (4); CZ (4); BR (3); CO (4); RO (3); FR (4)