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

Launched by NOVARTIS PHARMACEUTICALS · Nov 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called secukinumab to see if it helps people with a condition called non-radiographic axial spondyloarthritis (nr-axSpA) maintain their improvement over time. Participants in this study have already achieved remission, which means their disease activity is very low. The trial will compare those who continue taking secukinumab to a group that receives a placebo (a harmless substance that looks like the real medication) to see how many people stay free from flare-ups over a period of 120 weeks.

To be eligible for this trial, participants need to be at least 18 years old and have a clinical diagnosis of axial spondyloarthritis, which includes having had inflammatory back pain for at least six months and certain findings on MRI scans or blood tests. Participants should not have certain types of joint damage or other significant health issues. Those who join will receive either the medication or the placebo and will be monitored to see how well they maintain their remission. This study is currently recruiting participants of all genders, and it's an important step to understand the long-term benefits of secukinumab for managing this condition.

Gender

ALL

Eligibility criteria

• 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.