Uno studio per valutare l'effetto a lungo termine di TEV-48574 nella colite ulcerosa da moderata a grave o nel morbo di Crohn
Uno studio di estensione a lungo termine di fase 2b di 24 settimane, randomizzato, in doppio cieco, per determinare la farmacocinetica a lungo termine, l'efficacia, la sicurezza e la tollerabilità di TEV-48574 in pazienti adulti con colite ulcerosa da moderata a grave o morbo di Crohn che hanno completato la fase principale dello studio di dosaggio (RELIEVE UCCD LTE)
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).
Secondary objectives of the study are to:
- evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
- evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
- evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Vienna, Austria, 1090
- Teva Investigational Site 33056
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Gorna Oryahovitsa, Bulgaria, 5100
- Teva Investigational Site 59243
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Sofia, Bulgaria, 1618
- Teva Investigational Site 59197
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Sofia, Bulgaria, 1784
- Teva Investigational Site 59196
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Brno, Cechia, 615 00
- Teva Investigational Site 54221
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Klatovy, Cechia, 339 01
- Teva Investigational Site 54222
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Slaný, Cechia, 274 01
- Teva Investigational Site 54220
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Tbilisi, Georgia, 0180
- Teva Investigational Site 81053
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Tbilisi, Georgia, 0119
- Teva Investigational Site 81052
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Kiel, Germania, 24105
- Teva Investigational Site 32793
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Tübingen, Germania, 72076
- Teva Investigational Site 32795
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Ulm, Germania, 89081
- Teva Investigational Site 32794
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Wipperfürth, Germania, 51688
- Teva Investigational Site 32874
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Kashiwa, Giappone, 277-0871
- Teva Investigational Site 84110
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Minato, Giappone, 108-8642
- Teva Investigational Site 84117
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Sakura, Giappone, 285-8741
- Teva Investigational Site 84114
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Shinjuku, Giappone, 169-0073
- Teva Investigational Site 84116
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Toyama, Giappone, 930-8550
- Teva Investigational Site 84111
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Afula, Israele, 1834111
- Teva Investigational Site 80179
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Beersheba, Israele, 8410101
- Teva Investigational Site 80191
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Milan, Italia, 20132
- Teva Investigational Site 30285
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Milan, Italia, 20157
- Teva Investigational Site 30286
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Rozzano, Italia, 20089
- Teva Investigational Site 30284
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Lorenskog, Norvegia, 1478
- Teva Investigational Site 41015
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Bydgoszcz, Polonia, 85-794
- Teva Investigational Site 53565
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Częstochowa, Polonia, 42-202
- Teva Investigational Site 53542
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Elblag, Polonia, 82-300
- Teva Investigational Site 53543
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Gdansk, Polonia, 80-382
- Teva Investigational Site 53544
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Katowice, Polonia, 40-040
- Teva Investigational Site 53546
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Krakow, Polonia, 30-363
- Teva Investigational Site 53560
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Krakow, Polonia, 31-156
- Teva Investigational Site 53548
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Krakow, Polonia, 31-506
- Teva Investigational Site 53512
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Kłodzko, Polonia, 57-300
- Teva Investigational Site 53547
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Lodz, Polonia, 90-752
- Teva Investigational Site 53515
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Nowy Targ, Polonia, 34-400
- Teva Investigational Site 53518
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Poznan, Polonia, 60-529
- Teva Investigational Site 53516
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Poznan, Polonia, 60-702
- Teva Investigational Site 53566
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Poznan, Polonia, 54-144
- Teva Investigational Site 53549
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Poznan, Polonia, 54-144
- Teva Investigational Site 53563
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Sopot, Polonia, 81-756
- Teva Investigational Site 53550
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Staszów, Polonia, 28-200
- Teva Investigational Site 53551
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Szczecin, Polonia, 71-434
- Teva Investigational Site 53508
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Szczecin, Polonia, 71-685
- Teva Investigational Site 53519
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Torun, Polonia, 87-100
- Teva Investigational Site 53553
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Wadowice, Polonia, 34-100
- Teva Investigational Site 53554
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Warsaw, Polonia, 00-189
- Teva Investigational Site 53557
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Warsaw, Polonia, 02-672
- Teva Investigational Site 53570
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Warsaw, Polonia, 02-786
- Teva Investigational Site 53556
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Warsaw, Polonia, 04-501
- Teva Investigational Site 53555
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Wroclaw, Polonia, 52-416
- Teva Investigational Site 53510
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Wroclaw, Polonia, 53-149
- Teva Investigational Site 53567
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Wroclaw, Polonia, 53-673
- Teva Investigational Site 53520
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Wroclaw, Polonia, 53-611
- Teva Investigational Site 53562
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Zamość, Polonia, 22-400
- Teva Investigational Site 53509
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Łęczna, Polonia, 21-010
- Teva Investigational Site 53511
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London, Regno Unito, SE1 9RT
- Teva Investigational Site 34305
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Bardejov, Slovacchia, 085 01
- Teva Investigational Site 62074
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Bratislava, Slovacchia, 811 09
- Teva Investigational Site 62073
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Košice, Slovacchia, 040 13
- Teva Investigational Site 62071
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Prešov, Slovacchia, 080 01
- Teva Investigational Site 62076
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Prešov, Slovacchia, 080 01
- Teva Investigational Site 62097
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Huelva, Spagna, 21005
- Teva Investigational Site 31293
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Santiago de Compostela, Spagna, 15702
- Teva Investigational Site 31318
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Valencia, Spagna, 46026
- Teva Investigational Site 31292
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California
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San Diego, California, Stati Uniti, 92103
- Teva Investigational Site 15556
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Florida
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Kissimmee, Florida, Stati Uniti, 34741
- Teva Investigational Site 15357
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Orlando, Florida, Stati Uniti, 32803
- Teva Investigational Site 15375
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Pinellas Park, Florida, Stati Uniti, 33781
- Teva Investigational Site 15359
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Illinois
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Gurnee, Illinois, Stati Uniti, 60031
- Teva Investigational Site 15567
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Indiana
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New Albany, Indiana, Stati Uniti, 47150
- Teva Investigational Site 15574
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- Teva Investigational Site 15367
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40218
- Teva Investigational Site 15575
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Missouri
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Liberty, Missouri, Stati Uniti, 64068
- Teva Investigational Site 15358
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St Louis, Missouri, Stati Uniti, 63110
- Teva Investigational Site 15373
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89128.
- Teva Investigational Site 15369
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Ohio
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Beavercreek, Ohio, Stati Uniti, 45440
- Teva Investigational Site 15750
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Texas
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Harlingen, Texas, Stati Uniti, 78550
- Teva Investigational Site 15559
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Katy, Texas, Stati Uniti, 77494
- Teva Investigational Site 15366
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San Antonio, Texas, Stati Uniti, 78229
- Teva Investigational Site 15374
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Southlake, Texas, Stati Uniti, 76092
- Teva Investigational Site 15565
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Tyler, Texas, Stati Uniti, 75701
- Teva Investigational Site 15361
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Utah
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Salt Lake City, Utah, Stati Uniti, 84124
- Teva Investigational Site 15364
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Chernivtsi, Ucraina, 58002
- Teva Investigational Site 58327
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Ivano-Frankivsk, Ucraina, 76008
- Teva Investigational Site 58324
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Lviv, Ucraina, 79000
- Teva Investigational Site 58329
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Lviv, Ucraina, 79010
- Teva Investigational Site 58325
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Lviv, Ucraina, 79010
- Teva Investigational Site 58332
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Uzhhorod, Ucraina, 88018
- Teva Investigational Site 58322
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Vinnytsia, Ucraina, 21018
- Teva Investigational Site 58330
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Vinnytsia, Ucraina, 21018
- Teva Investigational Site 58331
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Budapest, Ungheria, 1085
- Teva Investigational Site 51334
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Budapest, Ungheria, H-1033
- Teva Investigational Site 51335
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Vác, Ungheria, H-2600
- Teva Investigational Site 51338
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
- Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
NOTE- Additional criteria may apply, please contact the investigator for more information
Exclusion Criteria:
- Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)
- Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician.
- Participant anticipates requiring major surgery during this study.
- Participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
NOTE- Additional criteria apply, please contact the investigator for more information
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC |
Subcutaneous (sc) administration using a commercial sc infusion system
Altri nomi:
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Sperimentale: TEV-48574 Dose Regimen A for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD |
Subcutaneous (sc) administration using a commercial sc infusion system
Altri nomi:
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Sperimentale: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC |
Subcutaneous (sc) administration using a commercial sc infusion system
Altri nomi:
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Sperimentale: TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD |
Subcutaneous (sc) administration using a commercial sc infusion system
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
Lasso di tempo: Week 44
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Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
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Week 44
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Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
Lasso di tempo: Week 44
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Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD |
Week 44
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Numero di partecipanti positivi all'ADA con presenza di ADA neutralizzante
Lasso di tempo: Settimane 0, 4, 8, 16, 28, 44 e 48
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Settimane 0, 4, 8, 16, 28, 44 e 48
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Numero di partecipanti che hanno interrotto l'assunzione del medicinale sperimentale (IMP) a causa di eventi avversi nel periodo in doppio cieco
Lasso di tempo: Fino alla settimana 48
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Fino alla settimana 48
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Numero di partecipanti che hanno interrotto l'assunzione del medicinale sperimentale (IMP) a causa di eventi avversi nel periodo in aperto (OL)
Lasso di tempo: Fino a 5 anni dopo l'inizio del periodo OL
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Fino a 5 anni dopo l'inizio del periodo OL
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Numero di partecipanti con anticorpi antifarmaco emergenti dal trattamento (ADA)
Lasso di tempo: Settimane 0, 4, 8, 16, 28, 44 e 48
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Settimane 0, 4, 8, 16, 28, 44 e 48
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Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
Lasso di tempo: Week 44
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Clinical response at week 44, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1 |
Week 44
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Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
Lasso di tempo: Week 44
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Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1 |
Week 44
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Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
Lasso di tempo: Week 44
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Endoscopic remission defined as a Mayo endoscopic subscore of 0 |
Week 44
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Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score
Lasso di tempo: Week 44
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Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44 |
Week 44
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Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index
Lasso di tempo: Week 44
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Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score |
Week 44
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Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
Lasso di tempo: Week 44
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Clinical remission defined as a CDAI score less than 150 |
Week 44
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Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD
Lasso di tempo: Week 44
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Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44 |
Week 44
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Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI
Lasso di tempo: Week 44
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Defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44 |
Week 44
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Number of participants who experience adverse events in the double-blind period
Lasso di tempo: Up to Week 48
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Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions. |
Up to Week 48
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Number of participants who experience adverse events in the open-label (OL) period
Lasso di tempo: Up to 5 years after start of OL period
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Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions. |
Up to 5 years after start of OL period
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Collaboratori e investigatori
Collaboratori
Investigatori
- Direttore dello studio: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TV48574-IMM-20038
- 2022-002593-89 (Identificatore di registro: EudraCT (EU))
- 2024-515027-11-00 (Identificatore di registro: CTIS (EU))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .