Clinical trial • Phase II • Immunology|Musculoskeletal
SPY072 for Rheumatoid arthritis|Psoriatic arthritis|Axial spondyloarthritis
Phase II trial of SPY072 for Rheumatoid arthritis|Psoriatic arthritis|Axial spondyloarthritis.
Overview
- Trial Therapeutic Area
- Immunology|Musculoskeletal
- Trial Disease
- Rheumatoid arthritis|Psoriatic arthritis|Axial spondyloarthritis
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 18-08-2025
- First CTIS Authorization Date
- 25-11-2025
Trial design
Randomised, spypbo-101 placebo to spy072 (placebo). no dose or schedule for comparator specified in the公开 record.-controlled Phase II trial in Poland, Bulgaria, Czechia and others.
- Randomised
- Yes
- Comparator
- SPYPBO-101 Placebo to SPY072 (placebo). No dose or schedule for comparator specified in the公开 record.
- Target Sample Size
- 183
Eligibility
Recruits 183 No vulnerable population selected. The trial enrols adults only; country-specific adult informed consent forms are provided (English, Polish, Bulgarian, Czech, Spanish). No assent or minor-consent procedures are described in the application..
- Vulnerable Population
- No vulnerable population selected. The trial enrols adults only; country-specific adult informed consent forms are provided (English, Polish, Bulgarian, Czech, Spanish). No assent or minor-consent procedures are described in the application.
Inclusion criteria
- {"criterion_text":"- RA Substudy: Documented diagnosis of RA and adherence to the meeting the 2010 ACR/European League Against Rheumatism classification criteria for ≥6 months prior to Screening. axSpA Substudy: axSpA for ≥6 months with onset age of <45 years and 1 of the following: a. Meets the modified New York criteria (1984) for axSpA including documented radiologic evidence (X-ray) based on medical records OR b. Meets the 2009 ASAS classification criteria for non-radiographic axSpA (nr-axSpA) with a history of active sacroiliitis on magnetic resonance imaging. c. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, AND Back pain ≥4 (from BASDAI Item 2) at Screening and Day 1. PsA Substudy: Documented diagnosis of adult-onset PsA meeting the Classification Criteria for PsA ≥6 months prior to Screening.\n- RA Substudy: 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. axSpA Substudy: Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND Day 1: a. BASDAI ≥4, AND b. Back pain ≥4 (from BASDAI Item 2). PsA Substudy: Screening and Day 1 tender joint count ≥3 out of 68 and swollen joint count ≥3 out of 66 (dactylitis counts as 1 joint each).\n- RA Substudy: Documentation of ≥1 of the following: a. Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR b. Radiology report documenting bony erosions in hands or feet consistent with RA on previous radiographs. axSpA Substudy: hsCRP greater than the ULN per the central laboratory at Screening. PsA Substudy: Negative for rheumatoid factor at Screening.\n- RA Substudy: Class I, II, or III of the ACR 1991 Revised Criteria for Global Functional Status in RA. axSpA Substudy: Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to: a. 2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; AND/OR b. ≤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). PsA Substudy: ≥1 active plaque psoriasis lesion and/or a documented history of psoriasis.\n- RA Substudy: hsCRP greater than the ULN per the central laboratory at Screening. axSpA Substudy: hsCRP greater than the ULN per the central laboratory at Screening. PsA Substudy: hsCRP greater than the ULN per the central laboratory at Screening."}
Exclusion criteria
- {"criterion_text":"- RA Substudy: Inadequate response to >2 classes of bDMARDs/tsDMARDs. axSpA Substudy: Inadequate response to >2 classes of bDMARDs/tsDMARDs. PsA Substudy: Inadequate response to >2 classes of bDMARDs/tsDMARDs.\n- RA Substudy: Recent exposure to any of the following: - tsDMARDs within 2 weeks prior to Day 1 or bDMARDs within 4 weeks prior to Day 1 unless drug levels are undetected. - Rituximab within 6 months prior to Day 1 unless B cell counts have recovered in the Investigator’s judgement as per local guidelines. - Cell depleting therapy including but not limited to anti-CD4, anti-CD5, anti-CD3, ocrelizumab, or ofatumumab within 1 year prior to Day 1. - Systemic tacrolimus, azathioprine, parenteral gold, 6-mercaptopurine, 6-thioguanine, cyclosporine, mycophenolate mofetil, immunoadsorption, or D-penicillamine within 4 weeks prior to Day 1, leflunomide within 24 months prior to Day 1 unless the participant has completed cholestyramine elimination treatment and leflunomide levels are undetectable. - Intramuscular, intra-articular, intra-bursal, or intravenous (IV) corticosteroids within 6 weeks prior to Day 1. axSpA Substudy: Recent exposure to any of the following: - tsDMARDs within 2 weeks prior to Day 1 or bDMARDs within 4 weeks prior to Day 1 unless drug levels undetected. - Rituximab within 6 months unless B cell counts have recovered in the Investigator’s judgement as per local guidelines). - Intramuscular, intra-articular, intra-bursal, or IV corticosteroids: within 6 weeks prior to Day 1. PsA Substudy: Exposure to the following: - tsDMARDs within 2 weeks or bDMARDs within 4 weeks prior to Day 1, unless drug levels are undetectable. - Systemic tacrolimus, azathioprine, parenteral gold, 6-mercaptopurine, 6-thioguanine, cyclosporine, mycophenolate mofetil, immunoadsorption, or D-penicillamine within 4 weeks prior to Day 1. - Leflunomide within 24 months unless the participant has completed cholestyramine elimination treatment and leflunomide levels are undetectable. - Intramuscular, intra-articular, intra-bursal, or IV corticosteroids: within 6 weeks prior to Day 1."}
Endpoints
Primary endpoints
- {"endpoint_text":"- RA Substudy: Change from baseline in DAS28-CRP at Week 12.\n- axSpA Substudy: Change in ASDAS from baseline to Week 16.\n- PsA Substudy: Proportion of participants who achieve an ACR20 response at Week 16.","definition_or_measurement_approach":"RA: DAS28-CRP change from baseline measured at Week 12 using 28-joint count and CRP. axSpA: Change in ASDAS (Ankylosing Spondylitis Disease Activity Score) from baseline to Week 16. PsA: Proportion achieving ACR20 response at Week 16 (ACR20 clinical response criteria)."}
Secondary endpoints
- {"endpoint_text":"- RA Substudy: Proportion of participants who achieve an ACR20 response at Week 12. axSpA Substudy: Proportion of participants who achieve an ASAS40 response at Week 16. PsA Substudy: Change in DAPSA from baseline to Week 16.","definition_or_measurement_approach":"RA: ACR20 response at Week 12 per ACR criteria. axSpA: ASAS40 response at Week 16 per ASAS criteria. PsA: Change in DAPSA (Disease Activity index for PSoriatic Arthritis) from baseline to Week 16."}
- {"endpoint_text":"- RA Substudy: PK concentration through Week 12. axSpA Substudy: PK concentration through Week 16. PsA Substudy: PK concentration through Week 16.","definition_or_measurement_approach":"Measurement of plasma pharmacokinetic concentrations of SPY072 at scheduled timepoints through the indicated weeks via central laboratory."}
- {"endpoint_text":"- RA Substudy: The proportion of participants with ADA through Week 12. axSpA Substudy: The proportion of participants with ADA through Week 16. PsA Substudy: The proportion of participants with ADA through Week 16.","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADA) presence through the indicated weeks using immunogenicity assays."}
- {"endpoint_text":"- RA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 12 and through the end of study. axSpA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 16 and through the end of study. PsA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation at Week 16 and through the end of study.","definition_or_measurement_approach":"Safety monitoring: recording and classification of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to discontinuation across indicated timepoints."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 183
- Recruitment Window Months
- 27
- Consent Approach
- Informed consent obtained from adult participants. Country-specific subject information and informed consent forms are provided (L1_Country ICF Main) in Polish, Bulgarian, English, Czech and Spanish; additional country-specific ICF variants include pregnant forms, genetic consent, biobank consent and privacy forms. Consent is expected to be provided by the adult participant; no assent or minor-consent procedures are described.
Methods
- Posters (country-specific) — recruitment posters are provided for Poland, Bulgaria, Czechia, Spain (K2_Recruitment Poster files).
- Flyers (country-specific) — recruitment flyers provided for Poland, Bulgaria, Czechia, Spain (K2_Recruitment Flyer files).
- Social media (country-specific) — recruitment social media assets provided for Poland, Bulgaria, Czechia, Spain and English (K2_Recruitment Social Media files).
- Central recruitment procedure documents (K1) describing recruitment and informed consent procedures combined (available in English and country languages).
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 236
Poland
- Earliest CTIS Part Ii Submission Date
- 24-11-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 151
- Number Of Sites
- 8
- Number Of Participants
- 67
Sites
- Site Name
- Etg Warszawa Sp. z o.o.
- Department Name
- 403_ETG Warszawa
- Principal Investigator Name
- Anna Rowinska-Osuch
- Principal Investigator Email
- a.rowinskaosuch@etg-network.com
- Contact Person Name
- Anna Rowinska-Osuch
- Contact Person Email
- a.rowinskaosuch@etg-network.com
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Department Name
- 401_CENTRUM MEDYCZNE PLEJADY
- Principal Investigator Name
- Alicja Wloch
- Principal Investigator Email
- alawloch@interia.pl
- Contact Person Name
- Alicja Wloch
- Contact Person Email
- alawloch@interia.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- 405_MICS Centrum Medyczne Warszawa
- Principal Investigator Name
- Agnieszka Zielinska
- Principal Investigator Email
- agnieszkazielinska@medycynakliniczna.pl
- Contact Person Name
- Agnieszka Zielinska
- Contact Person Email
- agnieszkazielinska@medycynakliniczna.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- 404_Futuremeds Łodz
- Principal Investigator Name
- Katarzyna Bartnicka - Maslowska
- Principal Investigator Email
- katarzyna.bartnicka@futuremeds.com
- Contact Person Name
- Katarzyna Bartnicka - Maslowska
- Contact Person Email
- katarzyna.bartnicka@futuremeds.com
- Site Name
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
- Department Name
- 407_Twoja Przychodnia NCM
- Principal Investigator Name
- Malgorzata Miakisz
- Principal Investigator Email
- miakisz@twojaprzychodnia.com
- Contact Person Name
- Malgorzata Miakisz
- Contact Person Email
- miakisz@twojaprzychodnia.com
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Department Name
- 408_reumatology
- Principal Investigator Name
- Jan Brzezicki
- Principal Investigator Email
- janisb@poczta.onet.pl
- Contact Person Name
- Jan Brzezicki
- Contact Person Email
- janisb@poczta.onet.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- 406_FutureMeds Gdynia
- Principal Investigator Name
- Barbara Grabowicz - Wasko
- Principal Investigator Email
- barbara.wasko@futuremeds.com
- Contact Person Name
- Barbara Grabowicz - Wasko
- Contact Person Email
- barbara.wasko@futuremeds.com
- Site Name
- Novamed Robert Koteras
- Department Name
- 402_Twoja Przychodnia Opolskie Centrum Medyczne
- Principal Investigator Name
- Grazyna Jaworska - Gorna
- Principal Investigator Email
- gjaworska@opolemed.com
- Contact Person Name
- Grazyna Jaworska - Gorna
- Contact Person Email
- gjaworska@opolemed.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 151
- Number Of Sites
- 5
- Number Of Participants
- 63
Sites
- Site Name
- Medical Center Medconsult Pleven OOD
- Department Name
- 503_Not applicable
- Principal Investigator Name
- Dimitar Nikolov
- Principal Investigator Email
- dnikolov_mclovech@abv.bg
- Contact Person Name
- Dimitar Nikolov
- Contact Person Email
- dnikolov_mclovech@abv.bg
- Site Name
- Diagnostic - consultative center V - Plovdiv - St. Luka EOOD
- Department Name
- 506_Not available
- Principal Investigator Name
- Melita Encheva
- Principal Investigator Email
- melita.encheva@gmail.com
- Contact Person Name
- Melita Encheva
- Contact Person Email
- melita.encheva@gmail.com
- Site Name
- Diagnostic Consultative Center Equita OOD
- Department Name
- 504_Not applicable
- Principal Investigator Name
- Daniela Kamburova
- Principal Investigator Email
- dkamburova5@gmail.com
- Contact Person Name
- Daniela Kamburova
- Contact Person Email
- dkamburova5@gmail.com
- Site Name
- Medical Center Medconsult Pleven OOD
- Department Name
- 502_Not applicable
- Principal Investigator Name
- Krasimira Tsoneva
- Principal Investigator Email
- dr.krasimira.tsoneva@abv.bg
- Contact Person Name
- Krasimira Tsoneva
- Contact Person Email
- dr.krasimira.tsoneva@abv.bg
- Site Name
- Outpatient Clinic For Individual Practice For Specialized Medical Assistance In Rheumatology Dr. Gergana Rumenova Avramova EOOD
- Department Name
- 505_Not applicable
- Principal Investigator Name
- Gergana Avramova
- Principal Investigator Email
- gergana_avramova@abv.bg
- Contact Person Name
- Gergana Avramova
- Contact Person Email
- gergana_avramova@abv.bg
Czechia
- Earliest CTIS Part Ii Submission Date
- 20-11-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 155
- Number Of Sites
- 6
- Number Of Participants
- 70
Sites
- Site Name
- Medical Plus s.r.o.
- Department Name
- 701_NA
- Principal Investigator Name
- Lucie Svarcova
- Principal Investigator Email
- svarcovalucie12@gmail.com
- Contact Person Name
- Lucie Svarcova
- Contact Person Email
- svarcovalucie12@gmail.com
- Site Name
- Pratia Prague s.r.o.
- Department Name
- 705_NA
- Principal Investigator Name
- Ludmila Krainová Moszkorzová
- Principal Investigator Email
- ludmila.krainova@pratia.com
- Contact Person Name
- Ludmila Krainová Moszkorzová
- Contact Person Email
- ludmila.krainova@pratia.com
- Site Name
- MUDr. Zuzana Stejfova - Revmatologicka ambulance
- Department Name
- 703_Revmatologicka ambulance
- Principal Investigator Name
- Zuzana Stejfova
- Principal Investigator Email
- stejfova.zuzana@seznam.cz
- Contact Person Name
- Zuzana Stejfova
- Contact Person Email
- stejfova.zuzana@seznam.cz
- Site Name
- Pratia Pardubice a.s.
- Department Name
- 704_NA
- Principal Investigator Name
- Marcela Svobodova
- Principal Investigator Email
- maca.svobodova@post.cz
- Contact Person Name
- Marcela Svobodova
- Contact Person Email
- maca.svobodova@post.cz
- Site Name
- L.K.N. Arthrocentrum s.r.o.
- Department Name
- 706_Interni a revmatolog ordinace
- Principal Investigator Name
- Libor Novosad
- Principal Investigator Email
- libor.novosad@email.cz
- Contact Person Name
- Libor Novosad
- Contact Person Email
- libor.novosad@email.cz
- Site Name
- CCR Ostrava s.r.o.
- Department Name
- 702_NA
- Principal Investigator Name
- Sylva Brtnikova
- Principal Investigator Email
- sylva.brtnikova@ccrostrava.com
- Contact Person Name
- Sylva Brtnikova
- Contact Person Email
- sylva.brtnikova@ccrostrava.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 174
- Number Of Sites
- 4
- Number Of Participants
- 36
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- 602: Reumatología
- Principal Investigator Name
- Francisco Javier Blanco Garcia
- Principal Investigator Email
- fblagar@sergas.es
- Contact Person Name
- Francisco Javier Blanco Garcia
- Contact Person Email
- fblagar@sergas.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- 601: Reumatología
- Principal Investigator Name
- Ricardo Blanco Alonso
- Principal Investigator Email
- ricardo.blanco@scsalud.es
- Contact Person Name
- Ricardo Blanco Alonso
- Contact Person Email
- ricardo.blanco@scsalud.es
- Site Name
- Futuremeds Spain S.L.
- Department Name
- 604: Reumatología
- Principal Investigator Name
- Raúl Moreno Domínguez
- Principal Investigator Email
- raul.moreno@futuremeds.com
- Contact Person Name
- Raúl Moreno Domínguez
- Contact Person Email
- raul.moreno@futuremeds.com
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- 603: Reumatología
- Principal Investigator Name
- Nadia Abdel-Kader Martin
- Principal Investigator Email
- abdelmartin@hotmail.com
- Contact Person Name
- Nadia Abdel-Kader Martin
- Contact Person Email
- abdelmartin@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Spyre Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Safety and other sponsor duties (sponsorDuties code: 8; contact SKYWAY-RD-Safety@spyre.com)
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Multiple sponsor duties including study management/oversight (sponsorDuties codes: 1,11,2,5,6,8); contact Clinicaltrial.Enquiries@parexel.com
- Name
- 4g Clinical LLC
- Responsibilities
- Sponsor duties code: 3 (as recorded); contact spyre@4gclinical.com
Third parties
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 8 (as recorded)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4 (central laboratory services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4 (laboratory services)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 15; value: eCOA questionnaires","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Deltamed Solutions Inc.","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC (Durham address)","duties_or_roles":"sponsorDuties code: 15 (Samples storage) and code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 15 (Packaging, Labeling Inventory & Distribution), 5, 6, 8, 9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC (Morrisville address)","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1, 11, 2, 5, 6, 8","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"sponsorDuties codes: 15 (exploratory testing of PD Serum) and 4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- SPY072
- Active Substance
- SPY072
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Investigational medicinal product (no EU marketing authorisation stated in record)
- Investigational Product Name
- SPYPBO-101 Placebo to SPY072
- Modality
- Other
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