BridgeMD
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
EU CTIS ID: 2023-509320-17-00
What this study is testing
To evaluate whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in participants who achieved a state of remission in Treatment Period 1
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or non-pregnant, non-lactating female participants at least 18 years of age.
- Clinical diagnosis of axSpA AND according to ASAS axSpA criteria: a. Inflammatory back pain for at least 6 months b. Onset before 45 years of age c. Sacroiliitis on MRI (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 ≥ 40 mm (0-100 mm) at baseline.
You likely can't join if
- 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
See the full eligibility 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: a. Inflammatory back pain for at least 6 months b. Onset before 45 years of age c. Sacroiliitis on MRI (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 ≥ 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Philippines
- Turkey
- Vietnam
- Thailand
- Mexico
- Brazil
- Israel
- Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Philippines; Turkey; Vietnam; Thailand; Mexico and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.