Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD (SKYLINE-LTE)
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).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Mendoza Province
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Lujan de Cuyo, Mendoza Province, Argentina, 5505
- Site 102
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Site 103
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New South Wales
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Concord, New South Wales, Australia, 2139
- Site 208
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Site 206
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Flemish Brabant
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Leuven, Flemish Brabant, Belgia, 3000
- Site 473
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
- Site 471
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Rio Grande Sul
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Passo Fundo, Rio Grande Sul, Brasil, 99010-260
- Site 126
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São Paulo
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Santo André, São Paulo, Brasil, 09080-110
- Site 128
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Los Lagos Region
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Osorno, Los Lagos Region, Chile, 5290000
- Site 153
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 8320000
- Site 152
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California
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La Jolla, California, Forente stater, 92037
- Site 023
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Lancaster, California, Forente stater, 93534
- Site 012
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Florida
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Kissimmee, Florida, Forente stater, 34741
- Site 007
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Louisiana
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Marrero, Louisiana, Forente stater, 70072
- Site 035
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Site 028
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Rhode Island
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Providence, Rhode Island, Forente stater, 02904
- Site 025
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Texas
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San Antonio, Texas, Forente stater, 78229
- Study Site 002
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Southlake, Texas, Forente stater, 76092
- Site 008
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Washington
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Tacoma, Washington, Forente stater, 98405
- Site 019
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Kutaisi, Georgia, 4600
- Site 584
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Marneuli, Georgia, 3000
- Site 589
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Tbilisi, Georgia, 0144
- Site 586
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Tbilisi, Georgia, 0144
- Site 583
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Tbilisi, Georgia, 0102
- Site 581
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Tbilisi, Georgia, 0114
- Site 588
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Tbilisi, Georgia, 0159
- Site 582
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Tbilisi, Georgia, 0159
- Site 587
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Athens, Hellas, 106 76
- Site 634
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Milan
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Legnano, Milan, Italia, 20025
- Site 673
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Verona
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Negrar, Verona, Italia, 37024
- Site 672
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-
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Amman, Jordan, 11196
- Site 424
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Amman, Jordan, 11942
- Site 421
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Irbid, Jordan, 21110
- Site 422
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Irbid, Jordan, 22110
- Site 423
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Coahuila
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Saltillo, Coahuila, Mexico, 25050
- Site 174
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Guanajuato
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Celaya, Guanajuato, Mexico, 38000
- Site 175
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Jalisco
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Tlajomulco de Zúñiga, Jalisco, Mexico, 45645
- Site 173
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Chisinau, Moldova, MD-2025
- Site 711
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Chisinau, Moldova, MD-2068
- Site 715
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Chisinau, Moldova, MD2025
- Site 712
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Bydgoszcz, Polen, 85-229
- Site 753
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Bydgoszcz, Polen, 85-794
- Site 732
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Krakow, Polen, 31-501
- Site 748
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Kłodzko, Polen, 57-300
- Site 750
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Lodz, Polen, 91-034
- Site 746
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Opole, Polen, 45-819
- Site 743
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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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Szczecin, Polen, 71-685
- Site 733
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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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Wroclaw, Polen, 53-611
- Site 747
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Bucharest, Romania, 020125
- Site 781
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Timișoara, Romania, 300239
- Site 788
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Belgrade, Serbia, 11000
- Site 802
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Belgrade, Serbia, 11000
- Site 803
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Belgrade, Serbia, 11000
- Site 807
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Zrenjanin, Serbia, 23000
- Site 801
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Bratislava, Slovakia, 811 09
- Site 823
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Košice, Slovakia, 040 13
- Site 822
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Prešov, Slovakia, 080 01
- Site 824
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Busan, Sør -Korea, 48108
- Site 357
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Daegu, Sør -Korea, 41404
- Site 354
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Daegu, Sør -Korea, 42601
- Site 361
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Daejeon, Sør -Korea, 34943
- Site 355
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Seoul, Sør -Korea, 03312
- Site 356
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Seoul, Sør -Korea, 06351
- Site 362
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Seoul, Sør -Korea, 07985
- Site 360
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Gangwon-do
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Wŏnju, Gangwon-do, Sør -Korea, 26426
- Site 353
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Changhua, Taiwan, 500
- Site 394
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Chiayi City, Taiwan, 600
- Site 392
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Kaohsiung City, Taiwan, 833401
- Site 395
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Taichung, Taiwan, 404327
- Site 396
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Taipei, Taiwan, 100225
- Site 391
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Brno, Tsjekkia, 615 00
- Site 531
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Ulm, Tyskland, 89081
- Site 603
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Ivano-Frankivsk, Ukraina, 76008
- Site 906
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Kyiv, Ukraina, 04050
- Site 913
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Kyiv, Ukraina, 04210
- Site 903
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Kyiv, Ukraina, 02091
- Site 904
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Kyiv, Ukraina, 02002
- Site 902
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Kyiv, Ukraina, 04106
- Site 911
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Lutsk, Ukraina, 43005
- Site 901
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Lviv, Ukraina, 79010
- Site 909
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Poltava, Ukraina, 36011
- Site 914
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Vinnytsia, Ukraina, 21009
- Site 908
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Vinnytsia, Ukraina, 21029
- Site 907
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Budapest, Ungarn, H-1088
- Site 651
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Békéscsaba, Ungarn, H-5600
- Site 654
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Székesfehérvár, Ungarn, H-8000
- Site 652
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Salzburg, Østerrike, 5020
- Site 461
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Upper Austria
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Linz, Upper Austria, Østerrike, 4021
- Site 463
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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.
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Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: SPY001 Dosing Regimen 1
Participants will receive SPY001 |
Experimental
Andre navn:
|
|
Eksperimentell: SPY002 Dosing Regimen 1
Participants will receive SPY002 |
Experimental
Andre navn:
|
|
Eksperimentell: SPY003 Dosing Regimen 1
Participants will receive SPY003 |
Experimental
Andre navn:
|
|
Eksperimentell: SPY001 Dosing Regimen 2
Participants will receive SPY001 |
Experimental
Andre navn:
|
|
Eksperimentell: SPY002 Dosing Regimen 2
Participants will receive SPY002 |
Experimental
Andre navn:
|
|
Eksperimentell: SPY003 Dosing Regimen 2
Participants will receive SPY003 |
Experimental
Andre navn:
|
|
Eksperimentell: SPY001 & SPY002
Participants will receive SPY001 and SPY002 |
Experimental
Andre navn:
Experimental
Andre navn:
|
|
Eksperimentell: SPY001 & SPY003
Participants will receive SPY001 and SPY003 |
Experimental
Andre navn:
Experimental
Andre navn:
|
|
Eksperimentell: SPY002 & SPY003
Participants will receive SPY002 and SPY003 |
Experimental
Andre navn:
Experimental
Andre navn:
|
|
Eksperimentell: SPY002 Dosing Regimen 3
Participants will receive SPY002 |
Experimental
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants who experienced an adverse event
Tidsramme: Week 96
|
Incidence of treatment-emergent adverse events (TEAEs) as measured over time. |
Week 96
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with endoscopic improvement
Tidsramme: Week 48
|
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. |
Week 48
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: SKYLINE Study Director, Spyre Therapeutics
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPY123-202
- 2025-524640-35-00 (Ctis)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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