Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD (SKYLINE-LTE)
11. september 2026 opdateret af: Spyre Therapeutics, Inc.
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).
Studieoversigt
Status
Tilmelding efter invitation
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
645
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Site 103
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Site 206
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgien, 9000
- Site 471
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California
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Lancaster, California, Forenede Stater, 93534
- Site 012
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Louisiana
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Marrero, Louisiana, Forenede Stater, 70072
- Site 035
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- Study Site 002
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Site 019
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Kutaisi, Georgien, 4600
- Site 584
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Tbilisi, Georgien, 0144
- Site 586
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Tbilisi, Georgien, 0144
- Site 583
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Tbilisi, Georgien, 0102
- Site 581
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Tbilisi, Georgien, 0114
- Site 588
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Tbilisi, Georgien, 0159
- Site 582
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Athens, Grækenland, 106 76
- Site 634
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Verona
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Negrar, Verona, Italien, 37024
- Site 672
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Amman, Jordan, 11196
- Site 424
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Irbid, Jordan, 21110
- Site 422
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Chisinau, Moldova, MD-2025
- Site 711
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Bydgoszcz, Polen, 85-229
- Site 753
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Bydgoszcz, Polen, 85-794
- Site 732
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Poznan, Polen, 60-309
- Site 740
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Rzeszów, Polen, 35-326
- Site 736
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Sopot, Polen, 81-756
- Site 744
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Szczecin, Polen, 71-434
- Site 737
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Tychy, Polen, 43-100
- Site 752
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Warsaw, Polen, 02-172
- Site 754
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Warsaw, Polen, 04-501
- Site 731
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Wroclaw, Polen, 52-416
- Site 738
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Wroclaw, Polen, 54-239
- Site 742
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Wroclaw, Polen, 53-149
- Site 734
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Timișoara, Rumænien, 300239
- Site 788
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Belgrade, Serbien, 11000
- Site 802
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Zrenjanin, Serbien, 23000
- Site 801
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Bratislava, Slovakiet, 811 09
- Site 823
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Prešov, Slovakiet, 080 01
- Site 824
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Busan, Sydkorea, 48108
- Site 357
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Daegu, Sydkorea, 42601
- Site 361
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Seoul, Sydkorea, 03312
- Site 356
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Gangwon-do
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Wŏnju, Gangwon-do, Sydkorea, 26426
- Site 353
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Chiayi City, Taiwan, 600
- Site 392
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Taichung, Taiwan, 404327
- Site 396
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Taipei, Taiwan, 100225
- Site 391
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Brno, Tjekkiet, 615 00
- Site 531
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Ivano-Frankivsk, Ukraine, 76008
- Site 906
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Kyiv, Ukraine, 04050
- Site 913
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Kyiv, Ukraine, 04210
- Site 903
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Kyiv, Ukraine, 02091
- Site 904
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Kyiv, Ukraine, 02002
- Site 902
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Kyiv, Ukraine, 04106
- Site 911
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Lutsk, Ukraine, 43005
- Site 901
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Poltava, Ukraine, 36011
- Site 914
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Budapest, Ungarn, H-1088
- Site 651
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
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]).
Exclusion Criteria:
- 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
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: SPY001 Dosing Regimen 1
Participants will receive SPY001
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Eksperimentel
Andre navne:
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Eksperimentel: SPY002 Dosing Regimen 1
Participants will receive SPY002
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Eksperimentel
Andre navne:
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Eksperimentel: SPY003 Dosing Regimen 1
Participants will receive SPY003
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Eksperimentel
Andre navne:
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Eksperimentel: SPY001 Dosing Regimen 2
Participants will receive SPY001
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Eksperimentel
Andre navne:
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Eksperimentel: SPY002 Dosing Regimen 2
Participants will receive SPY002
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Eksperimentel
Andre navne:
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Eksperimentel: SPY003 Dosing Regimen 2
Participants will receive SPY003
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Eksperimentel
Andre navne:
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Eksperimentel: SPY001 & SPY002
Participants will receive SPY001 and SPY002
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Eksperimentel
Andre navne:
Eksperimentel
Andre navne:
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Eksperimentel: SPY001 & SPY003
Participants will receive SPY001 and SPY003
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Eksperimentel
Andre navne:
Eksperimentel
Andre navne:
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Eksperimentel: SPY002 & SPY003
Participants will receive SPY002 and SPY003
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Eksperimentel
Andre navne:
Eksperimentel
Andre navne:
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Eksperimentel: SPY002 Dosing Regimen 3
Participants will receive SPY002
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Eksperimentel
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of participants who experienced an adverse event
Tidsramme: Week 96
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Incidence of treatment-emergent adverse events (TEAEs) as measured over time.
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Week 96
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of participants with endoscopic improvement
Tidsramme: Week 48
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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.
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Week 48
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: SKYLINE Study Director, Spyre Therapeutics
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. juni 2026
Primær færdiggørelse (Anslået)
2. marts 2029
Studieafslutning (Anslået)
3. januar 2030
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPY123-202
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524640-35-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .