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RECRUITINGPhase 2INTERVENTIONAL

A Study of SPY072 in Rheumatic Disease

Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults With Moderately to Severely Active Rheumatologic Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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) Who Should NOT Join This Trial: - Inadequate response to \>2 classes of bDMARDs/tsDMARDs ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

SPY002-072

Experimental

DRUG

Placebo

Matching Placebo

Locations (20)

Site 113
Avondale, Arizona, United States
Site 114
Chula Vista, California, United States
Site 111
Covina, California, United States
Site 108
Tujunga, California, United States
Site 112
Upland, California, United States
Site 107
Whittier, California, United States
Site 109
Hialeah, Florida, United States
Site 106
Ormond Beach, Florida, United States
Site 110
Tampa, Florida, United States
Site 104
Duncansville, Pennsylvania, United States
Site 105
Corpus Christi, Texas, United States
Site 103
Tomball, Texas, United States
Site 102
Tomball, Texas, United States
Site 503
Lovech, Lovech, Bulgaria
Site 502
Pleven, Pleven, Bulgaria
Site 506
Plovdiv, Plovdiv, Bulgaria
Site 505
Plovdiv, Plovdiv, Bulgaria
Site 504
Varna, Varna, Bulgaria
Site 706
Hlučín, Hlučín, Czechia
Site 702
Moravská Ostrava, Ostrava-město, Czechia