A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Placebo: Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.
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.
Study 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.
Eligibility
Primary outcome measure(s)
- The proportion of participants remaining flare-free during Treatment Period 2 — Week 120
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
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Genk | Belgium | |
| Novartis Investigative Site | Bruges | Belgium | |
| Novartis Investigative Site | Ghent | Belgium | |
| Novartis Investigative Site | Mons | Belgium | |
| Novartis Investigative Site | Juiz de Fora | Minas Gerais | |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | |
| Novartis Investigative Site | Barretos | São Paulo | |
| Novartis Investigative Site | Bogota | Cundinamarca | |
| Novartis Investigative Site | Bogota | Cundinamarca | |
| Novartis Investigative Site | Chía | Cundinamarca | |
| Novartis Investigative Site | Bucaramanga | Santander Department | |
| 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 | 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 | |
| Novartis Investigative Site | Debrecen | Hajdu Bihar Megye | |
| 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 | |
| Novartis Investigative Site | Torino | TO | |
| Novartis Investigative Site | Negrar | VR | |
| Novartis Investigative Site | Verona | VR | |
| Novartis Investigative Site | Kuala Lumpur | Malaysia | |
| Novartis Investigative Site | Chihuahua City | Chihuahua |
+ 22 more sites — see the full list on the official registry below.
On this site
📄 Cosentyx (secukinumab) drug profile →More Novartis Pharmaceuticals trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05622708 on ClinicalTrials.gov ↗ ← All trials in Mexico