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New drug SPY002-072 aims to tame multiple inflammatory joint diseases

NCT ID NCT07148414

Disease control Sponsor: Spyre Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study tests an experimental drug called SPY002-072 in 285 adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis. Participants receive either the drug or a placebo, and researchers measure changes in disease activity over time. The goal is to see if the drug can safely reduce joint pain, swelling, and inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPY002-072 (also called SPY072), an experimental drug
What this could lead to
If successful, this could lead to a new treatment option for people with inflammatory rheumatic diseases like rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.
What could go wrong
This is an early Phase 2 proof-of-concept study, so results are not yet proven. The drug may not work better than placebo, and side effects are still being studied.
Why investors are watching

Spyre Therapeutics is running a Phase 2 trial of its drug SPY002-072 in 285 adults with rheumatic disease, a group of autoimmune conditions. For a small company, this readout tests whether the drug works and is safe enough to justify further development. A clear result matters because the company's value depends on this single program's progress.

If it works: If the trial shows SPY002-072 beats placebo with acceptable safety, Spyre could advance the drug to later-stage testing. That outcome would validate the company's research approach and support its pipeline.

If it fails: The trial could fail to show a benefit over placebo, or safety problems could emerge, which would likely end the program. Many Phase 2 trials fail, so a negative result is a real possibility for a company this size.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 285 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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. ≥1 csDMARD treatment; AND/OR 2. ≤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: 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: 1. 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. ≤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. ≥1 NSAID treatment; AND 2. ≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (\>2 classes of bDMARDs and/or tsDMARDs is exclusionary) Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis Collagen Diseases pleomorphic adenoma psoriatic arthritis rheumatic disorder rheumatoid arthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondyloarthritis AXSPA PSA (psoriatic arthritis) Psoriatic arthritis Rheumatic diseases Rheumatic joint disease Rheumatoid arthritis Rheumatologic disease

Contacts and locations

Locations

  • Site 102

    Tomball, Texas, 77377, United States

  • Site 103

    Tomball, Texas, 77375, United States

  • Site 104

    Duncansville, Pennsylvania, 16635, United States

  • Site 105

    Corpus Christi, Texas, 78404, United States

  • Site 106

    Ormond Beach, Florida, 32174, United States

  • Site 107

    Whittier, California, 90602, United States

  • Site 108

    Tujunga, California, 91042, United States

  • Site 109

    Hialeah, Florida, 33016, United States

  • Site 110

    Tampa, Florida, 33614, United States

  • Site 111

    Covina, California, 91722, United States

  • Site 112

    Upland, California, 91786, United States

  • Site 113

    Avondale, Arizona, 85392, United States

  • Site 114

    Chula Vista, California, 91910, United States

  • Site 115

    Aventura, Florida, 33180, United States

  • Site 116

    Willowbrook, Illinois, 60527, United States

  • Site 118

    Tucson, Arizona, 85748, United States

  • Site 119

    Rockville, Maryland, 20850, United States

  • Site 120

    Irving, Texas, 75039, United States

  • Site 201

    Chisinau, MD-2025, Moldova

  • Site 202

    Chisinau, MD-2025, Moldova

  • Site 301

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

  • Site 302

    Kutaisi, 4600, Georgia

  • Site 303

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

  • Site 304

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

  • Site 305

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

  • Site 306

    Tbilisi, 0186, Georgia

  • Site 307

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

  • Site 308

    Batumi, 6010, Georgia

  • Site 401

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Site 402

    Opole, Opole Voivodeship, 45-819, Poland

  • Site 403

    Warsaw, Masovian Voivodeship, 02-677, Poland

  • Site 404

    Lodz, Lódzkie, 91-363, Poland

  • Site 405

    Warszawa, Pomeranian Voivodeship, 00-874, Poland

  • Site 406

    Gdynia, Pomeranian Voivodeship, 81-384, Poland

  • Site 407

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • Site 408

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

  • Site 502

    Pleven, Pleven, 5803, Bulgaria

  • Site 503

    Lovech, Lovech, 5500, Bulgaria

  • Site 504

    Varna, Varna, 9000, Bulgaria

  • Site 505

    Plovdiv, Plovdiv, 4003, Bulgaria

  • Site 506

    Plovdiv, Plovdiv, 4000, Bulgaria

  • Site 601

    Santander, Madrid, 39008, Spain

  • Site 602

    A Coruña, A Coruña, 15006, Spain

  • Site 603

    Seville, Sevilla, 41010, Spain

  • Site 604

    Chiclana de la Frontera, Cadiz, 11139, Spain

  • Site 701

    Uherské Hradiště, Zlín, 68601, Czechia

  • Site 702

    Moravská Ostrava, Ostrava-město, 702 00, Czechia

  • Site 703

    Prague, Praha, Hlavní Mesto, 140 00, Czechia

  • Site 704

    Pardubice, Pardubice Region, 530 02, Czechia

  • Site 705

    Prague, Praha, Hlavní Mesto, 130 00, Czechia

  • Site 706

    Hlučín, Hlučín, 748 01, Czechia

  • Site 801

    Vinnytsia, Vinnytsia Oblast, 21028, Ukraine

  • Site 802

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • Site 803

    Kyiv, Kyiv Oblast, 2125, Ukraine

  • Site 804

    Kyiv, Kyiv Oblast, 04050, Ukraine

  • Site 805

    Kyiv, Kyiv Oblast, 4106, Ukraine

  • Site 806

    Kyiv, Kyiv Oblast, 03049, Ukraine

  • Site 807

    Lviv, Lviv Oblast, 79044, Ukraine

  • Site 808

    Ternopil, Ternopil Oblast, 46002, Ukraine

  • Site 809

    Chernihiv, Chernihiv Oblast, 14029, Ukraine

  • Site 810

    Ternopil, Ternopil Oblast, 46002, Ukraine

  • Site 811

    Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

  • Site 812

    Vinnytsia, Vinnytska, 21000, Ukraine

  • Site 813

    Kyiv, Kyiv Oblast, 02091, Ukraine

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