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

NCT ID: NCT05622708

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2028-06-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-radiographic Axial Spondyloarthritis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Period 1

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

Group Type EXPERIMENTAL

Secukinumab

Intervention Type 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 2

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

Secukinumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Bruges, , Belgium

Site Status

Novartis Investigative Site

Genk, , Belgium

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Novartis Investigative Site

Ghent, , Belgium

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Novartis Investigative Site

Mons, , Belgium

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Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil

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Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

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Novartis Investigative Site

Barretos, São Paulo, Brazil

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Novartis Investigative Site

Bogota, Cundinamarca, Colombia

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Novartis Investigative Site

Bogota, Cundinamarca, Colombia

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Novartis Investigative Site

Chía, Cundinamarca, Colombia

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Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

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Novartis Investigative Site

Prague, , Czechia

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Novartis Investigative Site

Prague, , Czechia

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Novartis Investigative Site

Prague, , Czechia

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Novartis Investigative Site

Uherské Hradiště, , Czechia

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Novartis Investigative Site

Chambray-lès-Tours, , France

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Novartis Investigative Site

Le Mans, , France

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Nice, , France

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Paris, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Bad Doberan, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Herne, , Germany

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Ratingen, , Germany

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Rendsburg, , Germany

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Székesfehérvár, Fejér, Hungary

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Debrecen, Hajdu Bihar Megye, Hungary

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Novartis Investigative Site

Kistarcsa, , Hungary

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Miskolc, , Hungary

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Szeged, , Hungary

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Veszprém, , Hungary

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Kfar Saba, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Ancona, AN, Italy

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Bologna, BO, Italy

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Torino, TO, Italy

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Negrar, VR, Italy

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Verona, VR, Italy

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Novartis Investigative Site

Kuala Lumpur, , Malaysia

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Novartis Investigative Site

Guadalajara, Jalisco, Mexico

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Novartis Investigative Site

Guadalajara, Jalisco, Mexico

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Novartis Investigative Site

Mérida, Yucatán, Mexico

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Chihuahua City, , Mexico

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Novartis Investigative Site

Heerlen, Limburg, Netherlands

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Novartis Investigative Site

Amsterdam, North Holland, Netherlands

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Novartis Investigative Site

Makati City, National Capital Region, Philippines

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Novartis Investigative Site

Manila, , Philippines

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Novartis Investigative Site

Krakow, Lesser Poland Voivodeship, Poland

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Novartis Investigative Site

Bydgoszcz, , Poland

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Novartis Investigative Site

Krakow, , Poland

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Novartis Investigative Site

Sochaczew, , Poland

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Novartis Investigative Site

Torun, , Poland

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Novartis Investigative Site

Warsaw, , Poland

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Novartis Investigative Site

Cluj-Napoca, Cluj, Romania

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Novartis Investigative Site

Bucharest, , Romania

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Novartis Investigative Site

Bucharest, , Romania

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Novartis Investigative Site

Bangkok, , Thailand

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Novartis Investigative Site

Bangkok, , Thailand

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Novartis Investigative Site

Adana, Yuregir, Turkey (Türkiye)

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Novartis Investigative Site

Konya, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ho Chi Minh City, VNM, Vietnam

Site Status

Novartis Investigative Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Belgium Brazil Colombia Czechia France Germany Hungary Israel Italy Malaysia Mexico Netherlands Philippines Poland Romania Thailand Turkey (Türkiye) Vietnam

Other Identifiers

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2022-001153-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-509320-17-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAIN457I2401

Identifier Type: -

Identifier Source: org_study_id