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New antibody cocktail aims to tame ulcerative colitis for good

NCT ID NCT07652294

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 16, 2026 · Updated 19 times

Summary

This study is testing three long-acting antibodies, alone or in combination, in 645 people with ulcerative colitis. The goal is to see if they are safe and can improve bowel inflammation over 48 weeks. Participants are joining from a previous study and may have already seen some benefit.

What this could mean

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

Active substance
SPY001, SPY002, SPY003 (long-acting antibodies)
What this could lead to
If successful, this could point toward a new long-term treatment option for ulcerative colitis that may help control the disease with fewer doses.
What could go wrong
This is an early-phase extension study, so results are preliminary. The antibodies may not prove effective or safe over the long term, and side effects are possible.

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 645 people

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

Started

Jun 2026

Expected to finish

Jan 2030

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: Participants must meet 1 of the following criteria from Study SPY123-201: 1. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator 2. Completed Part B 3. Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period \[ITP\] or experienced disease worsening during the maintenance treatment period \[MTP\]). Exclusion Criteria: 1. Met any treatment discontinuation criteria from Study SPY123-201. 2. Is on any of the following prohibited medications: 1. Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate) 2. Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects 3. Any marketed advanced therapy (ie, biologic or small molecule) 4. Any investigational therapy other than SPY123-201 study drug 5. Total parenteral nutrition 3. Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance. 4. Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

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Conditions

The condition(s) this trial relates to.

colitis inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Colitis Colitis ulcerative Inflammatory bowel diseases Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    52 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site 012

    Lancaster, California, 93534, United States

  • Site 019

    Tacoma, Washington, 98405, United States

  • Site 035

    Marrero, Louisiana, 70072, United States

  • Site 103

    Rosario, Santa Fe Province, 2000, Argentina

  • Site 206

    South Brisbane, Queensland, 4101, Australia

  • Site 353

    Wŏnju, Gangwon-do, 26426, South Korea

  • Site 356

    Seoul, 03312, South Korea

  • Site 357

    Busan, 48108, South Korea

  • Site 361

    Daegu, 42601, South Korea

  • Site 391

    Taipei, 100225, Taiwan

  • Site 392

    Chiayi City, 600, Taiwan

  • Site 396

    Taichung, 404327, Taiwan

  • Site 422

    Irbid, 21110, Jordan

  • Site 424

    Amman, 11196, Jordan

  • Site 471

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Site 531

    Brno, 615 00, Czechia

  • Site 581

    Tbilisi, 0102, Georgia

  • Site 582

    Tbilisi, 0159, Georgia

  • Site 583

    Tbilisi, 0144, Georgia

  • Site 584

    Kutaisi, 4600, Georgia

  • Site 586

    Tbilisi, 0144, Georgia

  • Site 588

    Tbilisi, 0114, Georgia

  • Site 634

    Athens, 106 76, Greece

  • Site 651

    Budapest, H-1088, Hungary

  • Site 672

    Negrar, Verona, 37024, Italy

  • Site 711

    Chisinau, MD-2025, Moldova

  • Site 731

    Warsaw, 04-501, Poland

  • Site 732

    Bydgoszcz, 85-794, Poland

  • Site 734

    Wroclaw, 53-149, Poland

  • Site 736

    Rzeszów, 35-326, Poland

  • Site 737

    Szczecin, 71-434, Poland

  • Site 738

    Wroclaw, 52-416, Poland

  • Site 740

    Poznan, 60-309, Poland

  • Site 742

    Wroclaw, 54-239, Poland

  • Site 744

    Sopot, 81-756, Poland

  • Site 752

    Tychy, 43-100, Poland

  • Site 753

    Bydgoszcz, 85-229, Poland

  • Site 754

    Warsaw, 02-172, Poland

  • Site 788

    Timișoara, 300239, Romania

  • Site 801

    Zrenjanin, 23000, Serbia

  • Site 802

    Belgrade, 11000, Serbia

  • Site 823

    Bratislava, 811 09, Slovakia

  • Site 824

    Prešov, 080 01, Slovakia

  • Site 901

    Lutsk, 43005, Ukraine

  • Site 902

    Kyiv, 02002, Ukraine

  • Site 903

    Kyiv, 04210, Ukraine

  • Site 904

    Kyiv, 02091, Ukraine

  • Site 906

    Ivano-Frankivsk, 76008, Ukraine

  • Site 911

    Kyiv, 04106, Ukraine

  • Site 913

    Kyiv, 04050, Ukraine

  • Site 914

    Poltava, 36011, Ukraine

  • Study Site 002

    San Antonio, Texas, 78229, United States

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