Une étude pour évaluer l'effet à long terme du TEV-48574 dans la colite ulcéreuse modérée à sévère ou la maladie de Crohn
Une étude d'extension à long terme de phase 2b de 24 semaines, randomisée, en double aveugle pour déterminer la pharmacocinétique à long terme, l'efficacité, l'innocuité et la tolérabilité du TEV-48574 chez les patients adultes atteints de colite ulcéreuse modérée à sévère ou de la maladie de Crohn qui ont terminé la phase principale de l'étude de dosage (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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Kiel, Allemagne, 24105
- Teva Investigational Site 32793
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Tübingen, Allemagne, 72076
- Teva Investigational Site 32795
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Ulm, Allemagne, 89081
- Teva Investigational Site 32794
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Wipperfürth, Allemagne, 51688
- Teva Investigational Site 32874
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Gorna Oryahovitsa, Bulgarie, 5100
- Teva Investigational Site 59243
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Sofia, Bulgarie, 1618
- Teva Investigational Site 59197
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Sofia, Bulgarie, 1784
- Teva Investigational Site 59196
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Huelva, Espagne, 21005
- Teva Investigational Site 31293
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Santiago de Compostela, Espagne, 15702
- Teva Investigational Site 31318
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Valencia, Espagne, 46026
- Teva Investigational Site 31292
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Tbilisi, Géorgie, 0180
- Teva Investigational Site 81053
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Tbilisi, Géorgie, 0119
- Teva Investigational Site 81052
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Budapest, Hongrie, 1085
- Teva Investigational Site 51334
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Budapest, Hongrie, H-1033
- Teva Investigational Site 51335
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Vác, Hongrie, H-2600
- Teva Investigational Site 51338
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Afula, Israël, 1834111
- Teva Investigational Site 80179
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Beersheba, Israël, 8410101
- Teva Investigational Site 80191
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Milan, Italie, 20132
- Teva Investigational Site 30285
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Milan, Italie, 20157
- Teva Investigational Site 30286
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Rozzano, Italie, 20089
- Teva Investigational Site 30284
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Kashiwa, Japon, 277-0871
- Teva Investigational Site 84110
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Minato, Japon, 108-8642
- Teva Investigational Site 84117
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Sakura, Japon, 285-8741
- Teva Investigational Site 84114
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Shinjuku, Japon, 169-0073
- Teva Investigational Site 84116
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Toyama, Japon, 930-8550
- Teva Investigational Site 84111
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Vienna, L'Autriche, 1090
- Teva Investigational Site 33056
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Lorenskog, Norvège, 1478
- Teva Investigational Site 41015
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Bydgoszcz, Pologne, 85-794
- Teva Investigational Site 53565
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Częstochowa, Pologne, 42-202
- Teva Investigational Site 53542
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Elblag, Pologne, 82-300
- Teva Investigational Site 53543
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Gdansk, Pologne, 80-382
- Teva Investigational Site 53544
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Katowice, Pologne, 40-040
- Teva Investigational Site 53546
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Krakow, Pologne, 30-363
- Teva Investigational Site 53560
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Krakow, Pologne, 31-156
- Teva Investigational Site 53548
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Krakow, Pologne, 31-506
- Teva Investigational Site 53512
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Kłodzko, Pologne, 57-300
- Teva Investigational Site 53547
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Lodz, Pologne, 90-752
- Teva Investigational Site 53515
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Nowy Targ, Pologne, 34-400
- Teva Investigational Site 53518
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Poznan, Pologne, 60-529
- Teva Investigational Site 53516
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Poznan, Pologne, 60-702
- Teva Investigational Site 53566
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Poznan, Pologne, 54-144
- Teva Investigational Site 53549
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Poznan, Pologne, 54-144
- Teva Investigational Site 53563
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Sopot, Pologne, 81-756
- Teva Investigational Site 53550
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Staszów, Pologne, 28-200
- Teva Investigational Site 53551
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Szczecin, Pologne, 71-434
- Teva Investigational Site 53508
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Szczecin, Pologne, 71-685
- Teva Investigational Site 53519
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Torun, Pologne, 87-100
- Teva Investigational Site 53553
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Wadowice, Pologne, 34-100
- Teva Investigational Site 53554
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Warsaw, Pologne, 00-189
- Teva Investigational Site 53557
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Warsaw, Pologne, 02-672
- Teva Investigational Site 53570
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Warsaw, Pologne, 02-786
- Teva Investigational Site 53556
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Warsaw, Pologne, 04-501
- Teva Investigational Site 53555
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Wroclaw, Pologne, 52-416
- Teva Investigational Site 53510
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Wroclaw, Pologne, 53-149
- Teva Investigational Site 53567
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Wroclaw, Pologne, 53-673
- Teva Investigational Site 53520
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Wroclaw, Pologne, 53-611
- Teva Investigational Site 53562
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Zamość, Pologne, 22-400
- Teva Investigational Site 53509
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Łęczna, Pologne, 21-010
- Teva Investigational Site 53511
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London, Royaume-Uni, SE1 9RT
- Teva Investigational Site 34305
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Bardejov, Slovaquie, 085 01
- Teva Investigational Site 62074
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Bratislava, Slovaquie, 811 09
- Teva Investigational Site 62073
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Košice, Slovaquie, 040 13
- Teva Investigational Site 62071
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Prešov, Slovaquie, 080 01
- Teva Investigational Site 62076
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Prešov, Slovaquie, 080 01
- Teva Investigational Site 62097
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Brno, Tchéquie, 615 00
- Teva Investigational Site 54221
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Klatovy, Tchéquie, 339 01
- Teva Investigational Site 54222
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Slaný, Tchéquie, 274 01
- Teva Investigational Site 54220
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Chernivtsi, Ukraine, 58002
- Teva Investigational Site 58327
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Ivano-Frankivsk, Ukraine, 76008
- Teva Investigational Site 58324
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Lviv, Ukraine, 79000
- Teva Investigational Site 58329
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Lviv, Ukraine, 79010
- Teva Investigational Site 58325
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Lviv, Ukraine, 79010
- Teva Investigational Site 58332
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Uzhhorod, Ukraine, 88018
- Teva Investigational Site 58322
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Vinnytsia, Ukraine, 21018
- Teva Investigational Site 58330
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Vinnytsia, Ukraine, 21018
- Teva Investigational Site 58331
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California
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San Diego, California, États-Unis, 92103
- Teva Investigational Site 15556
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Florida
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Kissimmee, Florida, États-Unis, 34741
- Teva Investigational Site 15357
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Orlando, Florida, États-Unis, 32803
- Teva Investigational Site 15375
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Pinellas Park, Florida, États-Unis, 33781
- Teva Investigational Site 15359
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Illinois
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Gurnee, Illinois, États-Unis, 60031
- Teva Investigational Site 15567
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Indiana
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New Albany, Indiana, États-Unis, 47150
- Teva Investigational Site 15574
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- Teva Investigational Site 15367
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Kentucky
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Louisville, Kentucky, États-Unis, 40218
- Teva Investigational Site 15575
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Missouri
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Liberty, Missouri, États-Unis, 64068
- Teva Investigational Site 15358
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St Louis, Missouri, États-Unis, 63110
- Teva Investigational Site 15373
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Nevada
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Las Vegas, Nevada, États-Unis, 89128.
- Teva Investigational Site 15369
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Ohio
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Beavercreek, Ohio, États-Unis, 45440
- Teva Investigational Site 15750
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Texas
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Harlingen, Texas, États-Unis, 78550
- Teva Investigational Site 15559
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Katy, Texas, États-Unis, 77494
- Teva Investigational Site 15366
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San Antonio, Texas, États-Unis, 78229
- Teva Investigational Site 15374
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Southlake, Texas, États-Unis, 76092
- Teva Investigational Site 15565
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Tyler, Texas, États-Unis, 75701
- Teva Investigational Site 15361
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Utah
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Salt Lake City, Utah, États-Unis, 84124
- Teva Investigational Site 15364
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
Autres noms:
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Expérimental: 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
Autres noms:
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Expérimental: 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
Autres noms:
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Expérimental: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Nombre de participants positifs à l'ADA avec présence d'ADA neutralisante
Délai: Semaines 0, 4, 8, 16, 28, 44 et 48
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Semaines 0, 4, 8, 16, 28, 44 et 48
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Nombre de participants ayant arrêté de prendre le médicament expérimental (IMP) en raison d'événements indésirables survenus au cours de la période en double aveugle
Délai: Jusqu'à la semaine 48
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Jusqu'à la semaine 48
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Nombre de participants ayant arrêté de prendre le médicament expérimental (IMP) en raison d'événements indésirables survenus au cours de la période ouverte (OL)
Délai: Jusqu'à 5 ans après le début de la période OL
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Jusqu'à 5 ans après le début de la période OL
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Nombre de participants présentant des anticorps anti-médicaments (ADA) apparus pendant le traitement
Délai: Semaines 0, 4, 8, 16, 28, 44 et 48
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Semaines 0, 4, 8, 16, 28, 44 et 48
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Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Directeur d'études: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TV48574-IMM-20038
- 2022-002593-89 (Identificateur de registre: EudraCT (EU))
- 2024-515027-11-00 (Identificateur de registre: CTIS (EU))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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