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SPY002-072 in Adults with Moderately to Severely Active Rheumatologic Disease
EU CTIS ID: 2025-521791-63-00
What this study is testing
RA Substudy: To assess the efficacy of SPY072 compared with placebo in reducing the disease activity of rheumatoid arthritis assessed by DAS28-CRP at Week 12. axSpA Substudy: To assess the efficacy of SPY072 compared with placebo in reducing the disease activity of axial spondyloarthritis assessed by ASDAS at Week 16. PsA Substudy: To assess the efficacy of SPY072 compared with placebo in reducing the disease activity of Psoriatic Arthritis as assessed by ACR20 at Week 16.
- Therapeutic exploratory (Phase II)
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
- RA Substudy: Documented diagnosis of RA and adherence to the meeting the 2010 ACR/European League Against Rheumatism classification criteria for ≥6 months prior to Screening. axSpA Substudy: axSpA for ≥6 months with onset age of <45 years and 1 of the following: a. Meets the modified New York criteria (1984) for axSpA including documented radiologic evidence (X-ray) based on medical records OR b. Meets the 2009 ASAS classification criteria for non-radiographic axSpA (nr-axSpA) with a history of active sacroiliitis on magnetic resonance imaging. c. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, AND Back pain ≥4 (from BASDAI Item 2) at Screening and Day 1. PsA Substudy: Documented diagnosis of adult-onset PsA meeting the Classification Criteria for PsA ≥6 months prior to Screening.
- RA Substudy: Moderate-to-severely active RA as defined by the presence of ≥4 swollen joints (based on 28 joint count) and ≥4 tender joints (based on 28 joint count) at Screening and Day 1. axSpA Substudy: Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND Day 1: a. BASDAI ≥4, AND b. Back pain ≥4 (from BASDAI Item 2). PsA Substudy: Screening and Day 1 tender joint count ≥3 out of 68 and swollen joint count ≥3 out of 66 (dactylitis counts as 1 joint each).
- RA Substudy: Documentation of ≥1 of the following: a. Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR b. Radiology report documenting bony erosions in hands or feet consistent with RA on previous radiographs. axSpA Substudy: hsCRP greater than the ULN per the central laboratory at Screening. PsA Substudy: Negative for rheumatoid factor at Screening.
- RA Substudy: Class I, II, or III of the ACR 1991 Revised Criteria for Global Functional Status in RA. axSpA Substudy: Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to: a. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; AND/OR b. ≤2 classes of bDMARD (anti-TNF or anti-IL-17/tsDMARD at an approved dose for ≥12 weeks (>2 classes of bDMARDs/tsDMARDs is exclusionary). PsA Substudy: ≥1 active plaque psoriasis lesion and/or a documented history of psoriasis.
- RA Substudy: hsCRP greater than the ULN per the central laboratory at Screening. axSpA Substudy: hsCRP greater than the ULN per the central laboratory at Screening. PsA Substudy: hsCRP greater than the ULN per the central laboratory at Screening.
You likely can't join if
- RA Substudy: Inadequate response to >2 classes of bDMARDs/tsDMARDs. axSpA Substudy: Inadequate response to >2 classes of bDMARDs/tsDMARDs. PsA Substudy: Inadequate response to >2 classes of bDMARDs/tsDMARDs.
- RA Substudy: Recent exposure to any of the following: - tsDMARDs within 2 weeks prior to Day 1 or bDMARDs within 4 weeks prior to Day 1 unless drug levels are undetected. - Rituximab within 6 months prior to Day 1 unless B cell counts have recovered in the Investigator’s judgement as per local guidelines. - Cell depleting therapy including but not limited to anti-CD4, anti-CD5, anti-CD3, ocrelizumab, or ofatumumab within 1 year prior to Day 1. - Systemic tacrolimus, azathioprine, parenteral gold, 6-mercaptopurine, 6-thioguanine, cyclosporine, mycophenolate mofetil, immunoadsorption, or D-penicillamine within 4 weeks prior to Day 1, leflunomide within 24 months prior to Day 1 unless the participant has completed cholestyramine elimination treatment and leflunomide levels are undetectable. - Intramuscular, intra-articular, intra-bursal, or intravenous (IV) corticosteroids within 6 weeks prior to Day 1. axSpA Substudy: Recent exposure to any of the following: - tsDMARDs within 2 weeks prior to Day 1 or bDMARDs within 4 weeks prior to Day 1 unless drug levels undetected. - Rituximab within 6 months unless B cell counts have recovered in the Investigator’s judgement as per local guidelines). - Intramuscular, intra-articular, intra-bursal, or IV corticosteroids: within 6 weeks prior to Day 1. PsA Substudy: Exposure to the following: - tsDMARDs within 2 weeks or bDMARDs within 4 weeks prior to Day 1, unless drug levels are undetectable. - Systemic tacrolimus, azathioprine, parenteral gold, 6-mercaptopurine, 6-thioguanine, cyclosporine, mycophenolate mofetil, immunoadsorption, or D-penicillamine within 4 weeks prior to Day 1. - Leflunomide within 24 months unless the participant has completed cholestyramine elimination treatment and leflunomide levels are undetectable. - Intramuscular, intra-articular, intra-bursal, or IV corticosteroids: within 6 weeks prior to Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Moldova, Republic of
- Ukraine
- United States
- Georgia
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 Moldova, Republic of; Ukraine; United States; Georgia. 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.