Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPY002-072 · 2 trials · 9 indications
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.
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.
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.
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| Rheumatoid Arthritis, Dose Regimen 1 | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY072 |
| Rheumatoid Arthritis, Dose Regimen 2 | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY072 |
| Psoriatic Arthritis | EXPERIMENTAL | Participants will receive double-blind dose of SPY072 |
| Axial Spondyloarthritis | EXPERIMENTAL | Participants will receive double-blind dose of SPY072 |
| Rhematoid Arthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Psoriatic Arthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Axial Spondyloarthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| SAD Cohorts, Experimental Arm | EXPERIMENTAL | Participants will receive a single dose of SPY002-072 in a dose escalation format |
| SAD Cohorts, Placebo Arm | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| Name | Type | Description |
|---|---|---|
| SPY002-072 | DRUG | Experimental |
| Placebo | DRUG | Matching Placebo |
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 rh...
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SPY002-072 is an investigational small molecule being studied for rheumatic diseases, including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. It is also being evaluated in healthy volunteers to assess its safety and tolerability. The drug is in clinical development and has not been approved by the FDA.
SPY002-072 targets TL1A, a protein involved in inflammatory pathways. By targeting TL1A, the drug aims to modulate the immune response associated with rheumatic conditions. This mechanism is being investigated in clinical trials for diseases such as rheumatoid arthritis and psoriatic arthritis.
SPY002-072 is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded under the ticker SYRE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy volunteers and patients with rheumatic diseases.
SPY002-072 is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy volunteers has been completed, and a Phase 2 study in rheumatic diseases is active but not recruiting. The drug is investigational and has not received FDA approval.
SPY002-072 has two clinical trials. NCT06622070 is a completed Phase 1 study in healthy volunteers with 40 participants. NCT07148414 is an active Phase 2 study in rheumatic diseases with 285 participants, covering conditions like rheumatoid arthritis and psoriatic arthritis across multiple countries.
SPY002-072 is also referred to as SPY072 in clinical trial documentation. The Phase 2 study NCT07148414 uses the name SPY072, while the Phase 1 study uses SPY002-072. Both names refer to the same investigational drug being developed by Spyre Therapeutics.