A Study of SPY072 in Rheumatic Disease

NCT07148414 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SPY002-072-201
• Study Type: interventional
• Target: 285
• Locations: 8 countries
• Sites: 63

Brief 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).

Conditions

Psoriatic Arthritis; Axial Spondyloarthritis; Rheumatic Diseases; Rheumatic Joint Disease; Rheumatoid Arthritis; AxSpA; Rheumatologic Disease; PsA (Psoriatic Arthritis)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Week 16

Secondary Outcomes (3)

• Rheumatoid Arthritis: Proportion of participants who achieve an ACR20 response

  Week 12

• Axial Spondyloarthritis: Proportion of participants who achieve an Assessment of Spondyloarthritis International Society (40% improvement) (ASAS40) response

  Week 16

• Psoriatic Arthritis: Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)

  Week 16

Study Arms (7)

Rheumatoid Arthritis, Dose Regimen 1

EXPERIMENTAL

Participants will receive double-blind dosing regimen 1 of SPY072

Drug: SPY002-072

Rheumatoid Arthritis, Dose Regimen 2

EXPERIMENTAL

Participants will receive double-blind dosing regimen 2 of SPY072

Drug: SPY002-072

Psoriatic Arthritis

EXPERIMENTAL

Participants will receive double-blind dose of SPY072

Drug: SPY002-072

Axial Spondyloarthritis

EXPERIMENTAL

Participants will receive double-blind dose of SPY072

Drug: SPY002-072

Rhematoid Arthritis Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo

Drug: Placebo

Psoriatic Arthritis Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo

Drug: Placebo

Axial Spondyloarthritis Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo

Drug: Placebo

Interventions

SPY002-072 DRUG

Experimental

Also known as: SPY072

Axial Spondyloarthritis; Psoriatic Arthritis; Rheumatoid Arthritis, Dose Regimen 1; Rheumatoid Arthritis, Dose Regimen 2

Placebo DRUG

Matching Placebo

Axial Spondyloarthritis Placebo; Psoriatic Arthritis Placebo; Rhematoid Arthritis Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥1 csDMARD treatment; AND/OR
• 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:
• different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; AND/OR
• For psoriatic arthritis:

You may not qualify if:

• 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

Sponsors & Collaborators

• Spyre Therapeutics, Inc.: lead

Study Sites (63)

Site 113

Avondale, Arizona, 85392, United States

RECRUITING

Site 118

Tucson, Arizona, 85748, United States

RECRUITING

Site 114

Chula Vista, California, 91910, United States

RECRUITING

Site 111

Covina, California, 91722, United States

RECRUITING

Site 108

Tujunga, California, 91042, United States

RECRUITING

Site 112

Upland, California, 91786, United States

RECRUITING

Site 107

Whittier, California, 90602, United States

RECRUITING

Site 115

Aventura, Florida, 33180, United States

RECRUITING

Site 109

Hialeah, Florida, 33016, United States

RECRUITING

Site 106

Ormond Beach, Florida, 32174, United States

RECRUITING

Site 110

Tampa, Florida, 33614, United States

RECRUITING

Site 116

Willowbrook, Illinois, 60527, United States

RECRUITING

Site 119

Rockville, Maryland, 20850, United States

RECRUITING

Site 104

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Site 105

Corpus Christi, Texas, 78404, United States

RECRUITING

Site 120

Irving, Texas, 75039, United States

RECRUITING

Site 103

Tomball, Texas, 77375, United States

RECRUITING

Site 102

Tomball, Texas, 77377, United States

RECRUITING

Site 503

Lovech, Lovech, 5500, Bulgaria

RECRUITING

Site 502

Pleven, Pleven, 5803, Bulgaria

RECRUITING

Site 506

Plovdiv, Plovdiv, 4000, Bulgaria

RECRUITING

Site 505

Plovdiv, Plovdiv, 4003, Bulgaria

RECRUITING

Site 504

Varna, Varna, 9000, Bulgaria

RECRUITING

Site 706

Hlučín, Hlučín, 748 01, Czechia

RECRUITING

Site 702

Moravská Ostrava, Ostrava-město, 702 00, Czechia

RECRUITING

Site 704

Pardubice, Pardubice Region, 530 02, Czechia

RECRUITING

Site 705

Prague, Praha, Hlavní Mesto, 130 00, Czechia

RECRUITING

Site 703

Prague, Praha, Hlavní Mesto, 140 00, Czechia

RECRUITING

Site 303

Tbilisi, K'alak'i T'bilisi, 0102, Georgia

RECRUITING

Site 304

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

RECRUITING

Site 301

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

RECRUITING

Site 307

Tbilisi, K'alak'i T'bilisi, 0172, Georgia

RECRUITING

Site 305

Tbilisi, K'alak'i T'bilisi, 0186, Georgia

RECRUITING

Site 308

Batumi, 6010, Georgia

RECRUITING

Site 302

Kutaisi, 4600, Georgia

RECRUITING

Site 306

Tbilisi, 0186, Georgia

RECRUITING

Site 201

Chisinau, MD-2025, Moldova

RECRUITING

Site 202

Chisinau, MD-2025, Moldova

RECRUITING

Site 401

Krakow, Lesser Poland Voivodeship, 30-363, Poland

RECRUITING

Site 407

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

RECRUITING

Site 404

Lodz, Lódzkie, 91-363, Poland

RECRUITING

Site 403

Warsaw, Masovian Voivodeship, 02-677, Poland

RECRUITING

Site 402

Opole, Opole Voivodeship, 45-819, Poland

RECRUITING

Site 406

Gdynia, Pomeranian Voivodeship, 81-384, Poland

RECRUITING

Site 405

Warszawa, Pomeranian Voivodeship, 00-874, Poland

RECRUITING

Site 408

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

RECRUITING

Site 602

A Coruña, A Coruña, 15006, Spain

RECRUITING

Site 604

Chiclana de la Frontera, Cadiz, 11139, Spain

RECRUITING

Site 601

Santander, Madrid, 39008, Spain

RECRUITING

Site 603

Seville, Sevilla, 41010, Spain

RECRUITING

Site 809

Chernihiv, Chernihiv Oblast, 14029, Ukraine

RECRUITING

Site 813

Kyiv, Kyiv Oblast, 02091, Ukraine

RECRUITING

Site 806

Kyiv, Kyiv Oblast, 03049, Ukraine

RECRUITING

Site 804

Kyiv, Kyiv Oblast, 04050, Ukraine

RECRUITING

Site 803

Kyiv, Kyiv Oblast, 2125, Ukraine

RECRUITING

Site 805

Kyiv, Kyiv Oblast, 4106, Ukraine

RECRUITING

Site 807

Lviv, Lviv Oblast, 79044, Ukraine

RECRUITING

Site 808

Ternopil, Ternopil Oblast, 46002, Ukraine

RECRUITING

Site 810

Ternopil, Ternopil Oblast, 46002, Ukraine

RECRUITING

Site 801

Vinnytsia, Vinnytsia Oblast, 21028, Ukraine

RECRUITING

Site 802

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

RECRUITING

Site 812

Vinnytsia, Vinnytska, 21000, Ukraine

RECRUITING

Site 811

Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis; Rheumatic Diseases; Collagen Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis

Study Officials

• SKYWAY-RD Study Director

  Spyre Therapeutics

  STUDY DIRECTOR

Central Study Contacts

SKYWAY-RD Trial Center

CONTACT

+1-650-402-3164; info@skyway-rd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (8); ES (4); MO (2); PL (8); US (18); BU (5); CZ (5); UA (13)