285 Participants Needed

SPY072 for Rheumatoid Arthritis

(SKYWAY-RD Trial)

Recruiting at 12 trial locations
ST
Overseen BySKYWAY-RD Trial Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Spyre Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPY072, an experimental therapy, to determine its effectiveness for certain types of arthritis, including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. The study aims to assess both the efficacy and safety of SPY072. Participants will be divided into groups to receive either the treatment or a placebo, which contains no active medication. Individuals diagnosed with any of these types of arthritis who continue to experience symptoms despite other medications may find this trial suitable. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have an inadequate response to certain treatments, which might imply continuing some medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that SPY072 is likely to be safe for humans?

Earlier studies found that single doses of SPY072 up to 1500 mg were well-tolerated, with no serious side effects reported. The safety profile of SPY072 aligns with similar treatments, indicating it is generally safe. Tests on various groups, including those with rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis, provided this information. These results offer promise for treating rheumatic diseases, but further research is necessary to confirm its long-term safety.12345

Why do researchers think this study treatment might be promising for rheumatoid arthritis?

Researchers are excited about SPY072 because it's a promising new approach for treating rheumatoid arthritis. Unlike traditional treatments like methotrexate or TNF inhibitors, which mainly suppress the immune system to reduce inflammation, SPY072 targets specific pathways that may offer more precise control of the disease. This targeted mechanism could potentially lead to fewer side effects and improved effectiveness. Additionally, SPY072's formulation might allow for more convenient dosing, providing patients with a simpler and more manageable treatment option.

What evidence suggests that this trial's treatments could be effective?

Studies have shown that SPY072, a medication targeting a protein involved in inflammation, is well tolerated and shows promise in treating several joint-related conditions. Research indicates that SPY072 effectively interacts with this protein for up to 20 weeks, suggesting it might help reduce symptoms in conditions like rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. In this trial, participants with rheumatoid arthritis will receive one of two dosing regimens of SPY072, while others will receive it for psoriatic arthritis or axial spondyloarthritis. The treatment's movement through the body supports less frequent dosing, which could be more convenient for patients. Initial findings from earlier trials highlighted its potential in managing inflammation and improving patient outcomes.16789

Who Is on the Research Team?

SS

SKYWAY-RD Study Director

Principal Investigator

Spyre Therapeutics

Are You a Good Fit for This Trial?

Adults aged 18 or older with rheumatic diseases such as Psoriatic Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, or Axial Spondyloarthritis can join this study. Specific eligibility criteria are not provided but typically include a confirmed diagnosis and stable condition.

Inclusion Criteria

My condition did not improve after certain treatments.
My condition did not improve after certain treatments.
My RA is moderate to severe with specific joint issues and I have positive test results or X-rays.
See 2 more

Exclusion Criteria

Presence of other autoimmune, rheumatologic, inflammatory diseases, or pain-amplification syndromes
I have not improved after trying 2 or more specific arthritis medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive double-blind dosing regimen of SPY072 or placebo

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SPY072
Trial Overview The trial is testing the safety and effectiveness of a new medication called SPY072 against a placebo in treating various rheumatic conditions. Participants will be randomly assigned to receive either SPY072 or a placebo without knowing which one they're getting.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Rheumatoid Arthritis, Dose Regimen 2Experimental Treatment1 Intervention
Group II: Rheumatoid Arthritis, Dose Regimen 1Experimental Treatment1 Intervention
Group III: Psoriatic ArthritisExperimental Treatment1 Intervention
Group IV: Axial SpondyloarthritisExperimental Treatment1 Intervention
Group V: Rhematoid Arthritis PlaceboPlacebo Group1 Intervention
Group VI: Psoriatic Arthritis PlaceboPlacebo Group1 Intervention
Group VII: Axial Spondyloarthritis PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spyre Therapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
270+

Citations

Release DetailsInterim data from a Phase 1 trial demonstrated that SPY072 was well tolerated, exhibited prolonged pharmacokinetics, and rapidly and durably ...
Spyre initiates dosing in trial of rheumatic disease treatmentA Phase I study's interim data indicated that SPY072 was tolerated well, had extended pharmacokinetics, and reduced free TL1A levels. These ...
Release DetailsInterim data from a Phase 1 trial demonstrated that SPY072 was well tolerated, exhibited prolonged pharmacokinetics, and rapidly and durably ...
Spyre Therapeutics Announces Positive Interim Phase 1 ...Interim data from a Phase 1 trial demonstrated that SPY072 was well tolerated, exhibited prolonged pharmacokinetics, and rapidly and durably ...
Spyre Therapeutics: Positive Anti-TL1A Data Brings 2 ...Phase 1 data for Spyre Therapeutics, Inc.'s SPY002 & SPY072 show promise in autoimmune treatments. Advancing to Phase 2 trials.
EX-99.1Single doses of SPY002 and SPY072 up to 1500 mg were well-tolerated with a favorable safety profile consistent with existing third-party data of ...
Spyre Therapeutics Announces Poster Presentations at ...The data continue to show SPY072 is well tolerated, has a differentiated. PK profile supporting quarterly or twice-yearly dosing, and suppresses ...
A Study of SPY072 in Rheumatic DiseaseThis is a multi-center, double-blind, placebo-controlled, Phase 2, proof-of-concept basket study with the goal of assessing the efficacy and ...
Spyre Therapeutics Doses First Patient in Pioneering PhaseInterim data from a Phase 1 trial demonstrated that SPY072 was well tolerated, exhibited prolonged pharmacokinetics, and rapidly and durably ...
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