This is a multi-center, double-blind, placebo-controlled, Phase 2, proof-of-concept basket study with the goal of assessing the efficacy and safety of SPY072 compared to placebo in adults (aged ≥18 years) with rheumatic disease (RD).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
For rheumatoid arthritis:
* 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.
* Documentation of ≥1 of the following:
1. Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR
2. Radiology report documenting bony erosions in hands or feet consistent with RA on previous radiographs
* Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
1. ≥1 csDMARD treatment; AND/OR
2. ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary)
For axial spondyloarthritis:
* Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND Day 1:
1. BASDAI ≥4, AND
2. Back pain ≥4 (from BASDAI Item 2)
* hsCRP greater than the ULN per the central laboratory at Screening
* Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
1. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; AND/OR
2. ≤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)
For psoriatic arthritis:
* Screening and Day 1 TJC ≥3 out of 68 and SJC ≥3 out of 66 (dactylitis counts as 1 joint each)
* ≥1 active plaque psoriasis lesion and/or a documented history of psoriasis
* Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
1. ≥1 NSAID treatment; AND
2. ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary)
Exclusion Criteria:
* Inadequate response to \>2 classes of bDMARDs/tsDMARDs
* Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072
Primary outcome measure(s)
Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP) — Week 12 The score is calculated based on the number of tender and swollen joints out of 28 assessed (TJC28 and SJC28), a measure of inflammation in the blood (c-reactive protein, CRP), and the subject's overall assessment of their health (patient global assessment). Scores range from 0-10. Higher scores indicate greater disease activity.
Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS) — Week 16 The score combines 5 disease activity variables (back pain, duration of morning stiffness, patient global assessment of disease activity, peripheral pain/swelling and measure of inflammation) to measure disease activity. Lowest score is 0.6 and increases as disease worsens. Higher scores indicate greater disease activity.
Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) response — Week 16 The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts (TJC and SJC), and at least 20% improvement in 3 out of 5 other disease activity measures (patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire, and measure of inflammation) will be assessed.
Trial sites (64)
Facility
City
Region
Status
Site 113
Avondale
Arizona
Site 118
Tucson
Arizona
Site 114
Chula Vista
California
Site 111
Covina
California
Site 108
Tujunga
California
Site 112
Upland
California
Site 107
Whittier
California
Site 115
Aventura
Florida
Site 109
Hialeah
Florida
Site 106
Ormond Beach
Florida
Site 110
Tampa
Florida
Site 116
Willowbrook
Illinois
Site 119
Rockville
Maryland
Site 104
Duncansville
Pennsylvania
Site 105
Corpus Christi
Texas
Site 120
Irving
Texas
Site 103
Tomball
Texas
Site 102
Tomball
Texas
Site 503
Lovech
Lovech
Site 502
Pleven
Pleven
Site 506
Plovdiv
Plovdiv
Site 505
Plovdiv
Plovdiv
Site 504
Varna
Varna
Site 706
Hlučín
Hlučín
Site 702
Moravská Ostrava
Ostrava-město
Site 704
Pardubice
Pardubice Region
Site 705
Prague
Praha, Hlavní Mesto
Site 703
Prague
Praha, Hlavní Mesto
Site 701
Uherské Hradiště
Zlín
Site 303
Tbilisi
K'alak'i T'bilisi
Site 304
Tbilisi
K'alak'i T'bilisi
Site 301
Tbilisi
K'alak'i T'bilisi
Site 307
Tbilisi
K'alak'i T'bilisi
Site 305
Tbilisi
K'alak'i T'bilisi
Site 308
Batumi
Georgia
Site 302
Kutaisi
Georgia
Site 306
Tbilisi
Georgia
Site 201
Chisinau
Moldova
Site 202
Chisinau
Moldova
Site 401
Krakow
Lesser Poland Voivodeship
+ 24 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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