A Study of SPY072 in Rheumatic Disease

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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. 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.
≥1 csDMARD treatment; OR. 2. 1 bDMARD or 1 tsDMARD treatment (a total of 2 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 one of the following: 1.
2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; OR. 2. 1 bDMARD (anti-TNF or anti-IL-17) or 1 tsDMARD treatment at an approved dose for ≥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.
≥1 NSAID treatment; AND. 2. ≥1 csDMARD treatment; OR. 3. 1 bDMARD or 1 tsDMARD treatment (a total of 2 bDMARDs and/or tsDMARDs is exclusionary)

Exclusion Criteria:

  • - Inadequate response to ≥2 or more bDMARDs and/or tsDMARDs.
- Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07148414
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Spyre Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

SKYWAY-RD Study Director
Principal Investigator Affiliation Spyre Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Rheumatic Diseases, Rheumatic Joint Disease, PsA (Psoriatic Arthritis), AxSpA, Rheumatologic Disease
Additional Details

The basket study comprises of substudies in rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatric arthritis (PsA) as follows:

  • - RA substudy: Moderately to severely active RA despite treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic disease modifying anti-rheumatic drugs (bDMARDs), or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs) - axSpA substudy: Moderately to severely active axSpA despite treatment with non-steroidal anti-inflammatory drugs (NSAIDS), bDMARDs, or tsDMARDs.
- PsA substudy: Moderately to severely active PsA despite treatment with NSAIDs, csDMARDs, bDMARDs, or tsDMARDs

Arms & Interventions

Arms

Experimental: Rheumatoid Arthritis, Dose Regimen 1

Participants will receive double-blind dosing regimen 1 of SPY072

Experimental: Rheumatoid Arthritis, Dose Regimen 2

Participants will receive double-blind dosing regimen 2 of SPY072

Experimental: Psoriatic Arthritis

Participants will receive double-blind dose of SPY072

Experimental: Axial Spondyloarthritis

Participants will receive double-blind dose of SPY072

Placebo Comparator: Rhematoid Arthritis Placebo

Participants will receive matching placebo

Placebo Comparator: Psoriatic Arthritis Placebo

Participants will receive matching placebo

Placebo Comparator: Axial Spondyloarthritis Placebo

Participants will receive matching placebo

Interventions

Drug: - SPY002-072

Experimental

Drug: - Placebo

Matching Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Site 108, Tujunga 5403767, California 5332921

Status

Recruiting

Address

Site 108

Tujunga 5403767, California 5332921, 91042

Site Contact

SKYWAY-RD Trial Center

[email protected]

+1-650-402-3164

Site 101, Brookline 4931482, Massachusetts 6254926

Status

Recruiting

Address

Site 101

Brookline 4931482, Massachusetts 6254926, 02446

Site Contact

SKYWAY-RD Trial Center

[email protected]

+1-650-402-3164

Site 103, Tomball 4737094, Texas 4736286

Status

Recruiting

Address

Site 103

Tomball 4737094, Texas 4736286, 77375

Site Contact

SKYWAY-RD Trial Center

[email protected]

+1-650-402-3164

Site 102, Tomball 4737094, Texas 4736286

Status

Recruiting

Address

Site 102

Tomball 4737094, Texas 4736286, 77377

Site Contact

SKYWAY-RD Trial Center

[email protected]

+1-650-402-3164