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Clinical Trials in Germany / NCT05622708
Active, not recruiting Phase 4

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

NCT05622708 · tracked via the Priya Life Science Germany tracker
Phase
Phase 4
Started
2023-03-28
Last updated
2026-08-21

Condition(s) studied

Non-radiographic Axial Spondyloarthritis

Investigational drug(s) / intervention(s)

Secukinumab →PlaceboSecukinumab →

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)

Trial sites (62)

FacilityCityRegionStatus
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 Germany

Official registry record

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 Germany