New antibody cocktail aims to tame ulcerative colitis

NCT ID NCT07012395

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

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 10 times

Summary

This Phase 2 trial is testing three long-acting antibodies, alone or in combination, for people with moderate-to-severe ulcerative colitis. The study will enroll 645 adults to see if these treatments can reduce inflammation and lead to remission. Participants receive the antibodies through an IV infusion followed by regular shots under the skin.

What this could mean

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

Active substance: long-acting antibodies (SPY001, SPY002, SPY003)
What this could lead to: If successful, this could lead to a new treatment option that helps control ulcerative colitis with fewer doses, improving quality of life.
What could go wrong: This is an early Phase 2 trial, so results are uncertain. The antibodies may not work better than placebo, and side effects are possible.

Why investors are watching

Spyre Therapeutics is running a Phase 2 platform trial testing long-acting antibodies, alone and in combinations, for moderately to severely active ulcerative colitis. The trial plans to enroll 645 adults and will measure how well the drugs control the disease and their safety after IV induction and subcutaneous maintenance. For a small company, this readout is a major test of whether its lead drug candidates work in a large, competitive market.

If it works: A positive result could validate Spyre's antibody platform and support advancing the drugs into later-stage trials. That could strengthen the company's position in the ulcerative colitis treatment market.

If it fails: Phase 2 trials often fail to show enough benefit or reveal safety problems, and this one is large and complex. A failure or delay could set the company back significantly, since it has few other products in late-stage development.

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 645 people

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

Started

May 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 to 75 years

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: * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening * Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis) * Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2 Exclusion Criteria: * Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined * Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction * Failed 4 or more approved or investigational advanced therapy classes

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Get notified about this study

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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.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

267 sites in 35 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
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

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

029
RECRUITING

Miami, Florida, 33165, United States
040
RECRUITING

Chapel Hill, North Carolina, 27599, United States
Site 002
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San Antonio, Texas, 78229, United States
Site 003
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Boston, Massachusetts, 02114, United States
Site 004
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Seattle, Washington, 98195, United States
Site 005
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Garland, Texas, 75246, United States
Site 006
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Kansas City, Kansas, 66160, United States
Site 007
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Kissimmee, Florida, 34741, United States
Site 008
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Southlake, Texas, 76092, United States
Site 009
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Webster, Texas, 77598, United States
Site 011
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Glen Burnie, Maryland, 21061, United States
Site 012
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Lancaster, California, 93534, United States
Site 013
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Cedar Park, Texas, 78613, United States
Site 016
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Winston-Salem, North Carolina, 27103, United States
Site 017
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Kingsport, Tennessee, 37663, United States
Site 019
RECRUITING

Tacoma, Washington, 98405, United States
Site 023
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La Jolla, California, 92037, United States
Site 024
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Canoga Park, California, 91304, United States
Site 025
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Providence, Rhode Island, 02904, United States
Site 028
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Rochester, Minnesota, 55905, United States
Site 030
RECRUITING

Louisville, Kentucky, 40202, United States
Site 033
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Colorado Springs, Colorado, 91304, United States
Site 035
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Marrero, Louisiana, 70072, United States
Site 037
RECRUITING

New York, New York, 10065, United States
Site 038
RECRUITING

Chicago, Illinois, 60637, United States
Site 041
RECRUITING

Durham, North Carolina, 27710, United States
Site 083
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London, Ontario, G8H 3P7, Canada
Site 084
RECRUITING

Toronto, Ontario, M5G1X5, Canada
Site 085
RECRUITING

Greater Sudbury, P3C1X3, Canada
Site 086
RECRUITING

London, N6K 1M6, Canada
Site 102
RECRUITING

Lujan de Cuyo, Mendoza Province, 5505, Argentina
Site 103
RECRUITING

Rosario, Sant Fe, 2000, Argentina
Site 104
RECRUITING

San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Site 105
RECRUITING

La Plata, Buenos Aires, 1900, Argentina
Site 121
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Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Site 122
RECRUITING

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Site 123
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Brasília, Federal District, 70200-730, Brazil
Site 125
RECRUITING

Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Site 126
RECRUITING

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Site 127
RECRUITING

Santos, São Paulo, 11075-900, Brazil
Site 128
RECRUITING

Santo André, São Paulo, 09080-110, Brazil
Site 129
RECRUITING

Consolação, São Paulo, 01307-002, Brazil
Site 130
RECRUITING

São José do Rio Preto, São Paulo, 15015-110, Brazil
Site 131
RECRUITING

Campinas, São Paulo, 13086045, Brazil
Site 132
RECRUITING

São Paulo, 04077-020, Brazil
Site 133
RECRUITING

Goiânia, Goiás, 74535-170, Brazil
Site 134
RECRUITING

Passo Fundo, Rio Grande do Sul, 99010-120, Brazil
Site 135
RECRUITING

Barretos, São Paulo, 14.784-400, Brazil
Site 136
RECRUITING

Juiz de Fora, Minas Gerais, 36033-318, Brazil
Site 137
RECRUITING

Teresina, Piauí, 64.049-550, Brazil
Site 138
RECRUITING

Jaú, São Paulo, 17201-130, Brazil
Site 152
RECRUITING

Santiago, Santiago Metropolitan, 8320000, Chile
Site 153
RECRUITING

Osorno, Los Lagos Region, 5290000, Chile
Site 171
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Querétaro, 76000, Mexico
Site 172
RECRUITING

Coyoacán, Mexico City, 04100, Mexico
Site 173
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Tlajomulco de Zúñiga, Jalisco, 45645, Mexico
Site 174
RECRUITING

Saltillo, Coahuila, 25050, Mexico
Site 175
RECRUITING

Celaya, Guanajuato, 38000, Mexico
Site 202
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Heidelberg, 3084, Australia
Site 203
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Melbourne, 3004, Australia
Site 204
RECRUITING

Liverpool, 2170, Australia
Site 206
RECRUITING

South Brisbane, 4101, Australia
Site 207
RECRUITING

Woolloongabba, 4102, Australia
Site 208
RECRUITING

Concord, 2139, Australia
Site 262
RECRUITING

New Delhi, National Capital Territory of Delhi, 110002, India
Site 263
RECRUITING

New Delhi, National Capital Territory of Delhi, 110029, India
Site 265
RECRUITING

Sūrat, 395002, India
Site 266
RECRUITING

Kochi, 682040, India
Site 268
RECRUITING

Jaipur, 302004, India
Site 270
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Hyderabad, 500032, India
Site 281
RECRUITING

Shinjuku-Ku, Tokyo, 169-0073, Japan
Site 282
RECRUITING

Chuo Ku, Osaka, 540-0006, Japan
Site 283
RECRUITING

Tsu, Mie-ken, 514-8507, Japan
Site 284
RECRUITING

Okayama, 703-851, Japan
Site 285
RECRUITING

Sendai, 981-3213, Japan
Site 286
RECRUITING

Saga, 849-8501, Japan
Site 287
RECRUITING

Sendai, Miyagi, 983-8520, Japan
Site 288
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Osaka, 545-8586, Japan
Site 289
RECRUITING

Takatsuki, Osaka, 569-8686, Japan
Site 290
RECRUITING

Ōita, Oita Prefecture, 870-0823, Japan
Site 291
RECRUITING

Kobe, 650-0015, Japan
Site 292
RECRUITING

Shiwa-gun, Iwate, 028-3695, Japan
Site 293
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Urayasu-shi, 279-0021, Japan
Site 294
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Chikushino-shi, Fukuoka, 818-8502, Japan
Site 295
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Bunkyō-Ku, Tokyo, 113-8519, Japan
Site 296
RECRUITING

Minato-Ku, Tokyo, 108-8642, Japan
Site 297
RECRUITING

Sakura, Chiba, 285-8741, Japan
Site 299
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Kashiwa, Chiba, 277-0871, Japan
Site 300
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Yokohama, Kanagawa, 232-0024, Japan
Site 303
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Nara, 630-8581, Japan
Site 304
RECRUITING

Maebashi, Gunma, 371-8511, Japan
Site 351
RECRUITING

Seoul, 03722, South Korea
Site 352
RECRUITING

Seoul, 06591, South Korea
Site 353
RECRUITING

Wŏnju, 26426, South Korea
Site 354
RECRUITING

Daegu, 40404, South Korea
Site 355
RECRUITING

Daejeon, 34943, South Korea
Site 356
RECRUITING

Seoul, 03312, South Korea
Site 357
RECRUITING

Busan, 48108, South Korea
Site 358
RECRUITING

Daegu, 42415, South Korea
Site 359
RECRUITING

Suwon, 16247, South Korea
Site 360
RECRUITING

Seoul, 07985, South Korea
Site 361
RECRUITING

Daegu, 42601, South Korea
Site 362
RECRUITING

Seoul, 6351, South Korea
Site 391
RECRUITING

Taipei, 100225, Taiwan
Site 392
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Chiayi City, 600, Taiwan
Site 393
RECRUITING

Taoyuan City, 333, Taiwan
Site 394
RECRUITING

Changhua, 500, Taiwan
Site 395
RECRUITING

Kaohsiung City, 833401, Taiwan
Site 396
RECRUITING

Taichung, 404327, Taiwan
Site 397
RECRUITING

Taipei, 104, Taiwan
Site 421
RECRUITING

Amman, 11942, Jordan
Site 422
RECRUITING

Irbid, 21110, Jordan
Site 423
RECRUITING

Irbid, 22110, Jordan
Site 424
RECRUITING

Amman, 11196, Jordan
Site 425
RECRUITING

Amman, 11194, Jordan
Site 426
RECRUITING

Irbid, 22110, Jordan
Site 441
RECRUITING

Beersheba, 8410101, Israel
Site 442
RECRUITING

Nahariya, 2210001, Israel
Site 443
RECRUITING

Haifa, 31048, Israel
Site 444
RECRUITING

Jerusalem, 9103102, Israel
Site 445
RECRUITING

Beer Yaaqov, 7033001, Israel
Site 446
RECRUITING

Jerusalem, 9112001, Israel
Site 463
RECRUITING

Linz, 4021, Austria
Site 471
RECRUITING

Ghent, 9000, Belgium
Site 472
RECRUITING

Roeselare, 9000, Belgium
Site 474
RECRUITING

Sint-Niklaas, Osst-Vlaanderen, 9100, Belgium
Site 475
RECRUITING

Bruges, 8310, Belgium
Site 476
RECRUITING

Ghent, Osst-Vlaanderen, 9000, Belgium
Site 481
RECRUITING

Banja Luka, 78 000, Bosnia and Herzegovina
Site 483
RECRUITING

Sarajevo, 71000, Bosnia and Herzegovina
Site 484
RECRUITING

Mostar, 88000, Bosnia and Herzegovina
Site 492
RECRUITING

Sofia, 1343, Bulgaria
Site 494
RECRUITING

Gorna Oryahovitsa, 5100, Bulgaria
Site 495
RECRUITING

Sofia, 1463, Bulgaria
Site 498
RECRUITING

Rousse, 7002, Bulgaria
Site 499
RECRUITING

Sofia, 1407, Bulgaria
Site 521
RECRUITING

Osijek, 31000, Croatia
Site 524
RECRUITING

Zagreb, 10000, Croatia
Site 531
RECRUITING

Brno, 615 00, Czechia
Site 534
RECRUITING

Ostrava, 702 00, Czechia
Site 536
RECRUITING

Klatovy, 33901, Czechia
Site 537
RECRUITING

Pardubice, 532 03, Czechia
Site 538
RECRUITING

Prague, 150 00, Czechia
Site 551
RECRUITING

Nantes, 44300, France
Site 555
RECRUITING

Marseille, 13015, France
Site 556
RECRUITING

Pierre-Bénite, 69310, France
Site 557
RECRUITING

Nice, 06200, France
Site 558
RECRUITING

Saint-Etienne, 42270, France
Site 581
RECRUITING

Tbilisi, 0102, Georgia
Site 582
RECRUITING

Tbilisi, 0159, Georgia
Site 583
RECRUITING

Tbilisi, 01444, Georgia
Site 584
RECRUITING

Kutaisi, 4600, Georgia
Site 585
RECRUITING

Tbilisi, 0180, Georgia
Site 586
RECRUITING

Tbilisi, 0144, Georgia
Site 587
RECRUITING

Tbilisi, 0159, Georgia
Site 588
RECRUITING

Tbilisi, 0114, Georgia
Site 589
RECRUITING

Marneuli, 3000, Georgia
Site 590
RECRUITING

Tbilisi, 0178, Georgia
Site 602
RECRUITING

Kiel, 24105, Germany
Site 603
RECRUITING

Ulm, 89081, Germany
Site 604
RECRUITING

Berlin, 14163, Germany
Site 606
RECRUITING

Berlin, 10117, Germany
Site 607
RECRUITING

Dachau, 85221, Germany
Site 608
RECRUITING

Leipzig, 04103, Germany
Site 609
RECRUITING

Munich, 81377, Germany
Site 610
RECRUITING

Frankfurt am Main, 60590, Germany
Site 611
RECRUITING

Brandenburg an der Havel, 14770, Germany
Site 613
RECRUITING

Berlin, 14050, Germany
Site 631
RECRUITING

Chaïdári, 124 62, Greece
Site 632
RECRUITING

Athens, 115 27, Greece
Site 634
RECRUITING

Athens, 10676, Greece
Site 635
RECRUITING

Athens, Attica, 11527, Greece
Site 651
RECRUITING

Budapest, H-1088, Hungary
Site 652
RECRUITING

Székesfehérvár, H-8000, Hungary
Site 654
RECRUITING

Békéscsaba, H-5600, Hungary
Site 655
RECRUITING

Budapest, H-1062, Hungary
Site 656
RECRUITING

Budapest, H-1083, Hungary
Site 671
RECRUITING

Segrate, Milan, 20132, Italy
Site 672
RECRUITING

Negrar, 37024, Italy
Site 673
RECRUITING

Legnano, Milan, 20025, Italy
Site 674
RECRUITING

Rozzano, Milan, 20089, Italy
Site 675
RECRUITING

Turin, 10128, Italy
Site 676
RECRUITING

San Donato Milanese, Milan, 20097, Italy
Site 677
RECRUITING

Padova, 35128, Italy
Site 679
RECRUITING

Pavia, Lombardy, 27100, Italy
Site 680
RECRUITING

Turin, Piedmont, 10126, Italy
Site 681
RECRUITING

Rome, 00168, Italy
Site 682
RECRUITING

Castellana Grotte, Bari, 70013, Italy
Site 683
RECRUITING

Bologna, 40138, Italy
Site 703
RECRUITING

Vilnius, LT-08406, Lithuania
Site 704
RECRUITING

Klaipėda, LT-92288, Lithuania
Site 711
RECRUITING

Chisinau, MD2025, Moldova
Site 712
RECRUITING

Chisinau, MD2025, Moldova
Site 713
RECRUITING

Chisinau, MD2005, Moldova
Site 714
RECRUITING

Chisinau, MD2025, Moldova
Site 715
RECRUITING

Chisinau, MD2068, Moldova
Site 731
RECRUITING

Warsaw, 04-501, Poland
Site 732
RECRUITING

Bydgoszcz, 85-794, Poland
Site 733
RECRUITING

Szczecin, 71-685, Poland
Site 734
RECRUITING

Wroclaw, 53-149, Poland
Site 735
RECRUITING

Katowice, 40-748, Poland
Site 736
RECRUITING

Rzeszów, 35-326, Poland
Site 737
RECRUITING

Szczecin, 71-434, Poland
Site 738
RECRUITING

Wroclaw, 52-416, Poland
Site 739
RECRUITING

Warsaw, 00--710, Poland
Site 740
RECRUITING

Poznan, 60-309, Poland
Site 741
RECRUITING

Warsaw, 02-786, Poland
Site 742
RECRUITING

Wroclaw, 54-239, Poland
Site 743
RECRUITING

Opole, 45-819, Poland
Site 744
RECRUITING

Sopot, 81-756, Poland
Site 745
RECRUITING

Staszów, 28-2200, Poland
Site 747
RECRUITING

Wroclaw, 53-611, Poland
Site 748
RECRUITING

Krakow, 31-501, Poland
Site 749
RECRUITING

Katowice, 40-600, Poland
Site 750
RECRUITING

Warsaw, 57-300, Poland
Site 751
RECRUITING

Warsaw, 00-189, Poland
Site 752
RECRUITING

Tychy, 43-100, Poland
Site 753
RECRUITING

Bydgoszcz, 85-2299, Poland
Site 754
RECRUITING

Warsaw, 02-172, Poland
Site 781
RECRUITING

Bucharest, 020125, Romania
Site 782
RECRUITING

Cluj-Napoca, 400061, Romania
Site 783
RECRUITING

Bucharest, 011273, Romania
Site 784
RECRUITING

Bucharest, 014142, Romania
Site 786
RECRUITING

Constanța, 900161, Romania
Site 788
RECRUITING

Timișoara, 300239, Romania
Site 801
RECRUITING

Zrenjanin, 23000, Serbia
Site 802
RECRUITING

Belgrade, 11000, Serbia
Site 803
RECRUITING

Belgrade, 11080, Serbia
Site 805
RECRUITING

Niš, 18 000, Serbia
Site 806
RECRUITING

Užice, 31000, Serbia
Site 807
RECRUITING

Belgrade, 11000, Serbia
Site 821
RECRUITING

Prešov, 080 01, Slovakia
Site 822
RECRUITING

Košice, 040 13, Slovakia
Site 823
RECRUITING

Bratislava, 811 09, Slovakia
Site 825
RECRUITING

Zvolen, 960 01, Slovakia
Site 831
RECRUITING

Seville, 41013, Spain
Site 832
RECRUITING

Santiago de Compostela, A Coruna, 15702, Spain
Site 834
RECRUITING

Madrid, 28031, Spain
Site 835
RECRUITING

Gijón, 33394, Spain
Site 836
RECRUITING

Ourense, 32005, Spain
Site 837
RECRUITING

Madrid, 28222, Spain
Site 838
RECRUITING

Lugo, 27003, Spain
Site 851
RECRUITING

Sankt Gallen, 9007, Switzerland
Site 852
RECRUITING

Basel, 4031, Switzerland
Site 853
RECRUITING

Bern, 3012, Switzerland
Site 861
RECRUITING

Mersin, 33110, Turkey (Türkiye)
Site 862
RECRUITING

Trabzon, 61080, Turkey (Türkiye)
Site 863
RECRUITING

Sakarya, 54290, Turkey (Türkiye)
Site 864
RECRUITING

Izmir, 35575, Turkey (Türkiye)
Site 865
RECRUITING

Sanliurfa, 63300, Turkey (Türkiye)
Site 866
RECRUITING

İzmit, 41380, Turkey (Türkiye)
Site 867
RECRUITING

Istanbul, 34093, Turkey (Türkiye)
Site 901
RECRUITING

Lutsk, 43005, Ukraine
Site 902
RECRUITING

Kyiv, 02002, Ukraine
Site 903
RECRUITING

Kyiv, 04210, Ukraine
Site 904
RECRUITING

Kyiv, 02091, Ukraine
Site 905
RECRUITING

Kyiv, 03037, Ukraine
Site 906
RECRUITING

Ivano-Frankivsk, 76008, Ukraine
Site 907
RECRUITING

Vinnytsia, 21029, Ukraine
Site 908
RECRUITING

Vinnytsia, 21009, Ukraine
Site 909
RECRUITING

Lviv, 79010, Ukraine
Site 910
RECRUITING

Vinnytsia, 21028, Ukraine
Site 911
RECRUITING

Kyiv, 04107, Ukraine
Site 912
RECRUITING

Lviv, 79059, Ukraine
Site 913
RECRUITING

Kyiv, 04050, Ukraine
Site 914
RECRUITING

Poltava, 36011, Ukraine
Trial Site 804
RECRUITING

Belgrade, 11 000, Serbia

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