Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05622708

PHASE4

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-03-28

Completion Date

2028-06-13

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Non-radiographic Axial Spondyloarthritis

Interventions

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

Placebo

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

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.

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.

Locations (63)

Novartis Investigative Site

Bruges, Belgium

Novartis Investigative Site

Genk, Belgium

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Mons, Belgium

Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Chía, Cundinamarca, Colombia

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Uherské Hradiště, Czechia

Novartis Investigative Site

Chambray-lès-Tours, France

Novartis Investigative Site

Le Mans, France

Novartis Investigative Site

Nice, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Bad Doberan, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Herne, Germany

Novartis Investigative Site

Ratingen, Germany

Novartis Investigative Site

Székesfehérvár, Fejér, Hungary

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Kistarcsa, Hungary

Novartis Investigative Site

Miskolc, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Veszprém, Hungary

Novartis Investigative Site

Kfar Saba, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Negrar, VR, Italy

Novartis Investigative Site

Verona, VR, Italy

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Mérida, Yucatán, Mexico

Novartis Investigative Site

Chihuahua City, Mexico

Novartis Investigative Site

Heerlen, Limburg, Netherlands

Novartis Investigative Site

Amsterdam, North Holland, Netherlands

Novartis Investigative Site

Makati City, National Capital Region, Philippines

Novartis Investigative Site

Manila, Philippines

Novartis Investigative Site

Krakow, Lesser Poland Voivodeship, Poland

Novartis Investigative Site

Bydgoszcz, Poland

Novartis Investigative Site

Krakow, Poland

Novartis Investigative Site

Sochaczew, Poland

Novartis Investigative Site

Torun, Poland

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Cluj-Napoca, Cluj, Romania

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Adana, Yuregir, Turkey (Türkiye)

Novartis Investigative Site

Konya, Turkey (Türkiye)

Novartis Investigative Site

Ho Chi Minh City, VNM, Vietnam

Novartis Investigative Site

Ho Chi Minh City, Vietnam

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)