Phase
Condition
Rheumatoid Arthritis
Lupus
Ankylosing Spondylitis
Treatment
SPY002-072
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) atScreening and Day 1.
Documentation of ≥1 of the following:
Positive test results for rheumatoid factor or anti-citrullinated peptideantibodies at Screening, OR
Previous radiographs with bony erosions in hands or feet consistent with RA
- Inadequate response (defined as signs and symptoms of persistently active disease,loss of response, or intolerance) to one of the following:
≥1 csDMARD treatment; OR
1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs isexclusionary)
For axial spondyloarthritis:
- Moderate-to-severely active axSpA defined by BOTH of the following at Screening ANDDay 1:
BASDAI ≥4, AND
Back pain ≥4 (from BASDAI Item 2)
- hsCRP greater than the ULN per the central laboratory at Screening - Inadequateresponse (defined as signs and symptoms of persistently active disease, loss ofresponse, or intolerance) to one of the following:
2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks orintolerant to or has a contraindication to NSAID therapy; OR
1 bDMARD (anti-TNF or anti-IL-17) or 1 tsDMARD treatment at an approved dosefor ≥12 weeks (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)
For psoriatic arthritis:
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
In adequate response (defined as signs and symptoms of persistently active disease,loss of response, or intolerance) to one of the following:
≥1 NSAID treatment; AND
≥1 csDMARD treatment; OR
1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs isexclusionary)
Exclusion
Exclusion Criteria:
Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs
Other autoimmune, rheumatologic, inflammatory diseases or pain-amplificationsyndromes that might confound the evaluations of efficacy of SPY072
Study Design
Study Description
Connect with a study center
Site 503
Lovech 729559, Lovech 729560 5500
BulgariaActive - Recruiting
Site 704
Pardubice 3068582, Pardubický kraj 3339574 530 02
CzechiaActive - Recruiting
Site 301
Tbilisi 611717, K'alak'i T'bilisi 611716 0159
GeorgiaActive - Recruiting
Site 303
Tbilisi 611717, K'alak'i T'bilisi 611716 0102
GeorgiaActive - Recruiting
Site 304
Tbilisi 611717, K'alak'i T'bilisi 611716 0112
GeorgiaActive - Recruiting
Site 305
Tbilisi 611717, K'alak'i T'bilisi 611716 0186
GeorgiaActive - Recruiting
Site 307
Tbilisi 611717, K'alak'i T'bilisi 611716 0172
GeorgiaActive - Recruiting
Site 308
Batumi 615532, 6010
GeorgiaActive - Recruiting
Site 302
Kutaisi 613607, 4600
GeorgiaActive - Recruiting
Site 306
Tbilisi 611717, 0186
GeorgiaActive - Recruiting
Site 201
Chisinau 618426, MD-2025
MoldovaActive - Recruiting
Site 202
Chisinau 618426, MD-2025
MoldovaActive - Recruiting
Site 401
Krakow 3094802, Lesser Poland Voivodeship 858786 30-363
PolandActive - Recruiting
Site 403
Warsaw 756135, Masovian Voivodeship 858787 02-677
PolandActive - Recruiting
Site 405
Warszawa, Pomeranian Voivodeship 3337496 00-874
PolandActive - Recruiting
Site 113
Avondale 5552301, Arizona 5551752 85392
United StatesActive - Recruiting
Site 114
Chula Vista 5336899, California 5332921 91910
United StatesActive - Recruiting
Site 111
Covina 5340175, California 5332921 91722
United StatesActive - Recruiting
Site 108
Tujunga 5403767, California 5332921 91042
United StatesActive - Recruiting
Site 112
Upland 5404915, California 5332921 91786
United StatesActive - Recruiting
Site 107
Whittier 5409059, California 5332921 90602
United StatesActive - Recruiting
Site 109
Hialeah 4158476, Florida 4155751 33016
United StatesActive - Recruiting
Site 106
Ormond Beach 4167178, Florida 4155751 32174
United StatesActive - Recruiting
Site 110
Tampa 4174757, Florida 4155751 33614
United StatesActive - Recruiting
Site 101
Brookline 4931482, Massachusetts 6254926 02446
United StatesActive - Recruiting
Site 104
Duncansville 5187508, Pennsylvania 6254927 16635
United StatesActive - Recruiting
Site 105
Corpus Christi 4683416, Texas 4736286 78404
United StatesActive - Recruiting
Site 102
Tomball 4737094, Texas 4736286 77377
United StatesActive - Recruiting
Site 103
Tomball 4737094, Texas 4736286 77375
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.