Ulcerative ColitisPhase 2SKYLINE-LTENCT07652294
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
A Phase 2 study testing SPY001, SPY002 and SPY003 in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Spyre Therapeutics, Inc. at 86 sites in 22 countries.
Trial summary
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis
- What is being tested?
- SPY001, SPY002 and SPY003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 645 participants
- Where
- 86 sitesin 22 countries
- Study dates
- 8 Jun 2026to 3 Jan 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet 1 of the following criteria from Study SPY123-201:
- Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
- Completed Part B
- 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]).
Who cannot join
- Met any treatment discontinuation criteria from Study SPY123-201.
- Is on any of the following prohibited medications:
- Immunosuppressants (eg, azathioprine, 6-mercaptopurine [6-MP], or methotrexate)
- 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
- Any marketed advanced therapy (ie, biologic or small molecule)
- Any investigational therapy other than SPY123-201 study drug
Show all 9Show fewer
- Total parenteral nutrition
- 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.
- Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.
Trial locations and contacts
86 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
86 sites in 22 countries
Poland15 sites
Site 753
Bydgoszcz, 85-229
Site 732
Bydgoszcz, 85-794
Site 750
Kłodzko, 57-300
Site 743
Opole, 45-819
Site 740
Poznan, 60-309
Site 736
Rzeszów, 35-326
Site 744
Sopot, 81-756
Site 737
Szczecin, 71-434
Site 752
Tychy, 43-100
Site 754
Warsaw, 02-172
Site 731
Warsaw, 04-501
Site 738
Wroclaw, 52-416
Site 734
Wroclaw, 53-149
Site 747
Wroclaw, 53-611
Site 742
Wroclaw, 54-239
Ukraine11 sites
Site 906
Ivano-Frankivsk, 76008
Site 902
Kyiv, 02002
Site 904
Kyiv, 02091
Site 913
Kyiv, 04050
Site 911
Kyiv, 04106
Site 903
Kyiv, 04210
Site 901
Lutsk, 43005
Site 909
Lviv, 79010
Site 914
Poltava, 36011
Site 908
Vinnytsia, 21009
Site 907
Vinnytsia, 21029
Georgia8 sites
Site 584
Kutaisi, 4600
Site 589
Marneuli, 3000
Site 581
Tbilisi, 0102
Site 588
Tbilisi, 0114
Site 583
Tbilisi, 0144
Site 586
Tbilisi, 0144
Site 582
Tbilisi, 0159
Site 587
Tbilisi, 0159
United States7 sites
Site 007
Kissimmee, Florida, 34741
Site 012
Lancaster, California, 93534
Site 035
Marrero, Louisiana, 70072
Site 025
Providence, Rhode Island, 02904
Study Site 002
San Antonio, Texas, 78229
Site 008
Southlake, Texas, 76092
Site 019
Tacoma, Washington, 98405
South Korea7 sites
Site 357
Busan, 48108
Site 354
Daegu, 41404
Site 361
Daegu, 42601
Site 355
Daejeon, 34943
Site 356
Seoul, 03312
Site 360
Seoul, 07985
Site 353
Wŏnju, Gangwon-do, 26426
Taiwan5 sites
Site 394
Changhua, 500
Site 392
Chiayi City, 600
Site 395
Kaohsiung City, 833401
Site 396
Taichung, 404327
Site 391
Taipei, 100225
Jordan4 sites
Site 424
Amman, 11196
Site 421
Amman, 11942
Site 422
Irbid, 21110
Site 423
Irbid, 22110
Serbia4 sites
Site 802
Belgrade, 11000
Site 803
Belgrade, 11000
Site 807
Belgrade, 11000
Site 801
Zrenjanin, 23000
Mexico3 sites
Site 175
Celaya, Guanajuato, 38000
Site 174
Saltillo, Coahuila, 25050
Site 173
Tlajomulco de Zúñiga, Jalisco, 45645
Slovakia3 sites
Site 823
Bratislava, 811 09
Site 822
Košice, 040 13
Site 824
Prešov, 080 01
Australia2 sites
Site 208
Concord, New South Wales, 2139
Site 206
South Brisbane, Queensland, 4101
Belgium2 sites
Site 471
Ghent, Oost-Vlaanderen, 9000
Site 473
Leuven, Flemish Brabant, 3000
About this study
Official title: A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants With Inflammatory Bowel Disease
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Read the detailed description
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study) who have completed Part A and are deemed to be receiving clinical benefit, completed Part B, or met escape criteria in Part B. The primary aim of this LTE study is to characterize the long-term safety of various investigational drugs, to offer participants the option to extend treatment if they are clinically benefiting, or if they have not achieved sufficient clinical benefit (particularly placebo insufficient responders), to offer the opportunity to receive investigational drug.
- Being tested
- SPY001, SPY002, SPY003
- Keywords
- Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY001Drug
Also called SPY001-001
Experimental
SPY002Drug
Also called SPY002-091
Experimental
SPY003Drug
Also called SPY003-207
Experimental
| Study group | Role | What they receive |
|---|---|---|
| SPY001 Dosing Regimen 1 | Experimental | Participants will receive SPY001 Receives: Drug: SPY001 |
| SPY002 Dosing Regimen 1 | Experimental | Participants will receive SPY002 Receives: Drug: SPY002 |
| SPY003 Dosing Regimen 1 | Experimental | Participants will receive SPY003 Receives: Drug: SPY003 |
| SPY001 Dosing Regimen 2 | Experimental | Participants will receive SPY001 Receives: Drug: SPY001 |
| SPY002 Dosing Regimen 2 | Experimental | Participants will receive SPY002 Receives: Drug: SPY002 |
| SPY003 Dosing Regimen 2 | Experimental | Participants will receive SPY003 Receives: Drug: SPY003 |
| SPY001 & SPY002 | Experimental | Participants will receive SPY001 and SPY002 Receives: Drug: SPY001; Drug: SPY002 |
| SPY001 & SPY003 | Experimental | Participants will receive SPY001 and SPY003 Receives: Drug: SPY001; Drug: SPY003 |
| SPY002 & SPY003 | Experimental | Participants will receive SPY002 and SPY003 Receives: Drug: SPY002; Drug: SPY003 |
| SPY002 Dosing Regimen 3 | Experimental | Participants will receive SPY002 Receives: Drug: SPY002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who experienced an adverse event
Incidence of treatment-emergent adverse events (TEAEs) as measured over time.
Measured: Week 96
Secondary outcomes (1)
Percentage of participants with endoscopic improvement
Percentage of participants with endoscopic improvement at Week 48 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3). Higher score indicates more severe disease.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start8 Jun 2026
- Primary completion2 Mar 2029 (estimated)
- Study completion3 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 645 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spyre Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SKYLINE Study Director, Study director, Spyre Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652294
- Sponsor's protocol ID
- SPY123-202
- Other IDs
- 2025-524640-35-00, 2025
- Acronym
- SKYLINE-LTE
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No