Rheumatoid ArthritisPhase 2SKYWAY-RDNCT07148414
A Study of SPY072 in Rheumatic Disease
A Phase 2 study testing SPY002-072 in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Spyre Therapeutics, Inc. at 64 sites in 8 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis
- What is being tested?
- SPY002-072
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 64 sitesin 8 countries
- Study dates
- 21 Aug 2025to 31 Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR
- 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:
Show all 22Show fewer
- ≥1 csDMARD treatment; AND/OR
- ≤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:
- BASDAI ≥4, AND
- 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:
- 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 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 NSAID treatment; AND
- ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (>2 classes of bDMARDs and/or tsDMARDs is exclusionary)
Who cannot join
- 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
Trial locations and contacts
64 sites in 8 countries.
64 sites in 8 countries
United States18 sites
Site 115
Aventura, Florida, 33180
Site 113
Avondale, Arizona, 85392
Site 114
Chula Vista, California, 91910
Site 105
Corpus Christi, Texas, 78404
Site 111
Covina, California, 91722
Site 104
Duncansville, Pennsylvania, 16635
Site 109
Hialeah, Florida, 33016
Site 120
Irving, Texas, 75039
Site 106
Ormond Beach, Florida, 32174
Site 119
Rockville, Maryland, 20850
Site 110
Tampa, Florida, 33614
Site 103
Tomball, Texas, 77375
Site 102
Tomball, Texas, 77377
Site 118
Tucson, Arizona, 85748
Site 108
Tujunga, California, 91042
Site 112
Upland, California, 91786
Site 107
Whittier, California, 90602
Site 116
Willowbrook, Illinois, 60527
Ukraine13 sites
Site 809
Chernihiv, Chernihiv Oblast, 14029
Site 813
Kyiv, Kyiv Oblast, 02091
Site 806
Kyiv, Kyiv Oblast, 03049
Site 804
Kyiv, Kyiv Oblast, 04050
Site 803
Kyiv, Kyiv Oblast, 2125
Site 805
Kyiv, Kyiv Oblast, 4106
Site 807
Lviv, Lviv Oblast, 79044
Site 808
Ternopil, Ternopil Oblast, 46002
Site 810
Ternopil, Ternopil Oblast, 46002
Site 801
Vinnytsia, Vinnytsia Oblast, 21028
Site 802
Vinnytsia, Vinnytsia Oblast, 21029
Site 812
Vinnytsia, Vinnytska, 21000
Site 811
Zhytomyr, Zhytomyr Oblast, 10002
Georgia8 sites
Site 308
Batumi, 6010
Site 302
Kutaisi, 4600
Site 303
Tbilisi, K'alak'i T'bilisi, 0102
Site 304
Tbilisi, K'alak'i T'bilisi, 0112
Site 301
Tbilisi, K'alak'i T'bilisi, 0159
Site 307
Tbilisi, K'alak'i T'bilisi, 0172
Site 305
Tbilisi, K'alak'i T'bilisi, 0186
Site 306
Tbilisi, 0186
Poland8 sites
Site 408
Elblag, Warmian-Masurian Voivodeship, 82-300
Site 406
Gdynia, Pomeranian Voivodeship, 81-384
Site 401
Krakow, Lesser Poland Voivodeship, 30-363
Site 404
Lodz, Lódzkie, 91-363
Site 407
Nowa Sól, Lubusz Voivodeship, 67-100
Site 402
Opole, Opole Voivodeship, 45-819
Site 403
Warsaw, Masovian Voivodeship, 02-677
Site 405
Warszawa, Pomeranian Voivodeship, 00-874
Czechia6 sites
Site 706
Hlučín, Hlučín, 748 01
Site 702
Moravská Ostrava, Ostrava-město, 702 00
Site 704
Pardubice, Pardubice Region, 530 02
Site 705
Prague, Praha, Hlavní Mesto, 130 00
Site 703
Prague, Praha, Hlavní Mesto, 140 00
Site 701
Uherské Hradiště, Zlín, 68601
Bulgaria5 sites
Site 503
Lovech, Lovech, 5500
Site 502
Pleven, Pleven, 5803
Site 506
Plovdiv, Plovdiv, 4000
Site 505
Plovdiv, Plovdiv, 4003
Site 504
Varna, Varna, 9000
Spain4 sites
Site 602
A Coruña, A Coruña, 15006
Site 604
Chiclana de la Frontera, Cadiz, 11139
Site 601
Santander, Madrid, 39008
Site 603
Seville, Sevilla, 41010
About this study
Official title: Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults With Moderately to Severely Active Rheumatologic Disease
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).
Read the detailed description
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
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Rheumatic Diseases, Rheumatic Joint Disease, PsA (Psoriatic Arthritis)
- Being tested
- SPY002-072, Placebo
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Axial Spondyloarthritis, Rheumatic Diseases, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY002-072Drug
Also called SPY072
Experimental
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis, Dose Regimen 1 | Experimental | Participants will receive double-blind dosing regimen 1 of SPY072 Receives: Drug: SPY002-072 |
| Rheumatoid Arthritis, Dose Regimen 2 | Experimental | Participants will receive double-blind dosing regimen 2 of SPY072 Receives: Drug: SPY002-072 |
| Psoriatic Arthritis | Experimental | Participants will receive double-blind dose of SPY072 Receives: Drug: SPY002-072 |
| Axial Spondyloarthritis | Experimental | Participants will receive double-blind dose of SPY072 Receives: Drug: SPY002-072 |
| Rhematoid Arthritis Placebo | Placebo comparator | Participants will receive matching placebo Receives: Drug: Placebo |
| Psoriatic Arthritis Placebo | Placebo comparator | Participants will receive matching placebo Receives: Drug: Placebo |
| Axial Spondyloarthritis Placebo | Placebo comparator | Participants will receive matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)
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.
Measured: Week 12
Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS)
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.
Measured: Week 16
Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) response
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.
Measured: Week 16
Secondary outcomes (3)
Rheumatoid Arthritis: Proportion of participants who achieve an ACR20 response
The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts, and at least 20% improvement in 3 out of 5 other disease activity measures will be assessed.
Measured: Week 12
Axial Spondyloarthritis: Proportion of participants who achieve an Assessment of Spondyloarthritis International Society (40% improvement) (ASAS40) response
The proportion of subjects who achieve at least 40% improvement in at least 3 out of 4 key domains related to disease severity (patient global assessment of disease activity, back pain, physical function, inflammation) while not experiencing worsening in the remain domain will be assessed.
Measured: Week 16
Psoriatic Arthritis: Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
The sum of 5 key disease variables (tender joint count, swollen joint count, patient pain assessment, patient global assessment of disease activity, and C-reactive protein) will be assessed. Scores range from 0.1 to 86. Higher score indicates higher disease activity.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start21 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spyre Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SKYWAY-RD Study Director, Study director, Spyre Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148414
- Sponsor's protocol ID
- SPY002-072-201
- Acronym
- SKYWAY-RD
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No