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
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.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.
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.
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.
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