Eine Studie zur Bewertung der Langzeitwirkung von TEV-48574 bei mittelschwerer bis schwerer Colitis ulcerosa oder Morbus Crohn
Eine 24-wöchige Phase-2b-Langzeit-Verlängerungsstudie, randomisierte, doppelblinde Studie zur Bestimmung der Langzeit-Pharmakokinetik, Wirksamkeit, Sicherheit und Verträglichkeit von TEV-48574 bei erwachsenen Patienten mit mittelschwerer bis schwerer Colitis ulcerosa oder Morbus Crohn, die abgeschlossen wurden die Hauptphase der Dosisfindungsstudie (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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Gorna Oryahovitsa, Bulgarien, 5100
- Teva Investigational Site 59243
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Sofia, Bulgarien, 1618
- Teva Investigational Site 59197
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Sofia, Bulgarien, 1784
- Teva Investigational Site 59196
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Kiel, Deutschland, 24105
- Teva Investigational Site 32793
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Tübingen, Deutschland, 72076
- Teva Investigational Site 32795
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Ulm, Deutschland, 89081
- Teva Investigational Site 32794
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Wipperfürth, Deutschland, 51688
- Teva Investigational Site 32874
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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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Afula, Israel, 1834111
- Teva Investigational Site 80179
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Beersheba, Israel, 8410101
- Teva Investigational Site 80191
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Milan, Italien, 20132
- Teva Investigational Site 30285
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Milan, Italien, 20157
- Teva Investigational Site 30286
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Rozzano, Italien, 20089
- Teva Investigational Site 30284
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Kashiwa, Japan, 277-0871
- Teva Investigational Site 84110
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Minato, Japan, 108-8642
- Teva Investigational Site 84117
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Sakura, Japan, 285-8741
- Teva Investigational Site 84114
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Shinjuku, Japan, 169-0073
- Teva Investigational Site 84116
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Toyama, Japan, 930-8550
- Teva Investigational Site 84111
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Lorenskog, Norwegen, 1478
- Teva Investigational Site 41015
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Bydgoszcz, Polen, 85-794
- Teva Investigational Site 53565
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Częstochowa, Polen, 42-202
- Teva Investigational Site 53542
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Elblag, Polen, 82-300
- Teva Investigational Site 53543
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Gdansk, Polen, 80-382
- Teva Investigational Site 53544
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Katowice, Polen, 40-040
- Teva Investigational Site 53546
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Krakow, Polen, 30-363
- Teva Investigational Site 53560
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Krakow, Polen, 31-156
- Teva Investigational Site 53548
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Krakow, Polen, 31-506
- Teva Investigational Site 53512
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Kłodzko, Polen, 57-300
- Teva Investigational Site 53547
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Lodz, Polen, 90-752
- Teva Investigational Site 53515
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Nowy Targ, Polen, 34-400
- Teva Investigational Site 53518
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Poznan, Polen, 60-529
- Teva Investigational Site 53516
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Poznan, Polen, 60-702
- Teva Investigational Site 53566
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Poznan, Polen, 54-144
- Teva Investigational Site 53549
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Poznan, Polen, 54-144
- Teva Investigational Site 53563
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Sopot, Polen, 81-756
- Teva Investigational Site 53550
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Staszów, Polen, 28-200
- Teva Investigational Site 53551
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Szczecin, Polen, 71-434
- Teva Investigational Site 53508
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Szczecin, Polen, 71-685
- Teva Investigational Site 53519
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Torun, Polen, 87-100
- Teva Investigational Site 53553
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Wadowice, Polen, 34-100
- Teva Investigational Site 53554
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Warsaw, Polen, 00-189
- Teva Investigational Site 53557
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Warsaw, Polen, 02-672
- Teva Investigational Site 53570
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Warsaw, Polen, 02-786
- Teva Investigational Site 53556
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Warsaw, Polen, 04-501
- Teva Investigational Site 53555
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Wroclaw, Polen, 52-416
- Teva Investigational Site 53510
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Wroclaw, Polen, 53-149
- Teva Investigational Site 53567
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Wroclaw, Polen, 53-673
- Teva Investigational Site 53520
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Wroclaw, Polen, 53-611
- Teva Investigational Site 53562
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Zamość, Polen, 22-400
- Teva Investigational Site 53509
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Łęczna, Polen, 21-010
- Teva Investigational Site 53511
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Bardejov, Slowakei, 085 01
- Teva Investigational Site 62074
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Bratislava, Slowakei, 811 09
- Teva Investigational Site 62073
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Košice, Slowakei, 040 13
- Teva Investigational Site 62071
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Prešov, Slowakei, 080 01
- Teva Investigational Site 62076
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Prešov, Slowakei, 080 01
- Teva Investigational Site 62097
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Huelva, Spanien, 21005
- Teva Investigational Site 31293
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Santiago de Compostela, Spanien, 15702
- Teva Investigational Site 31318
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Valencia, Spanien, 46026
- Teva Investigational Site 31292
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Brno, Tschechien, 615 00
- Teva Investigational Site 54221
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Klatovy, Tschechien, 339 01
- Teva Investigational Site 54222
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Slaný, Tschechien, 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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Budapest, Ungarn, 1085
- Teva Investigational Site 51334
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Budapest, Ungarn, H-1033
- Teva Investigational Site 51335
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Vác, Ungarn, H-2600
- Teva Investigational Site 51338
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California
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San Diego, California, Vereinigte Staaten, 92103
- Teva Investigational Site 15556
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Florida
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Kissimmee, Florida, Vereinigte Staaten, 34741
- Teva Investigational Site 15357
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Orlando, Florida, Vereinigte Staaten, 32803
- Teva Investigational Site 15375
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Pinellas Park, Florida, Vereinigte Staaten, 33781
- Teva Investigational Site 15359
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Illinois
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Gurnee, Illinois, Vereinigte Staaten, 60031
- Teva Investigational Site 15567
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Indiana
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New Albany, Indiana, Vereinigte Staaten, 47150
- Teva Investigational Site 15574
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66160
- Teva Investigational Site 15367
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40218
- Teva Investigational Site 15575
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Missouri
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Liberty, Missouri, Vereinigte Staaten, 64068
- Teva Investigational Site 15358
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St Louis, Missouri, Vereinigte Staaten, 63110
- Teva Investigational Site 15373
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89128.
- Teva Investigational Site 15369
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Ohio
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Beavercreek, Ohio, Vereinigte Staaten, 45440
- Teva Investigational Site 15750
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Texas
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Harlingen, Texas, Vereinigte Staaten, 78550
- Teva Investigational Site 15559
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Katy, Texas, Vereinigte Staaten, 77494
- Teva Investigational Site 15366
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San Antonio, Texas, Vereinigte Staaten, 78229
- Teva Investigational Site 15374
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Southlake, Texas, Vereinigte Staaten, 76092
- Teva Investigational Site 15565
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Tyler, Texas, Vereinigte Staaten, 75701
- Teva Investigational Site 15361
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84124
- Teva Investigational Site 15364
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London, Vereinigtes Königreich, SE1 9RT
- Teva Investigational Site 34305
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Vienna, Österreich, 1090
- Teva Investigational Site 33056
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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
Andere Namen:
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Experimental: 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
Andere Namen:
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Experimental: 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
Andere Namen:
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Experimental: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Anzahl der ADA-positiven Teilnehmer mit neutralisierendem ADA
Zeitfenster: Wochen 0, 4, 8, 16, 28, 44 und 48
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Wochen 0, 4, 8, 16, 28, 44 und 48
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Anzahl der Teilnehmer, die die Einnahme des Prüfpräparats (IMP) aufgrund unerwünschter Ereignisse im Doppelblindzeitraum abgebrochen haben
Zeitfenster: Bis Woche 48
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Bis Woche 48
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Anzahl der Teilnehmer, die die Einnahme des Prüfpräparats (IMP) aufgrund unerwünschter Ereignisse im Open-Label-Zeitraum (OL) abgebrochen haben
Zeitfenster: Bis zu 5 Jahre nach Beginn der OL-Periode
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Bis zu 5 Jahre nach Beginn der OL-Periode
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Anzahl der Teilnehmer mit behandlungsbedingten Anti-Drug-Antikörpern (ADA)
Zeitfenster: Wochen 0, 4, 8, 16, 28, 44 und 48
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Wochen 0, 4, 8, 16, 28, 44 und 48
|
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Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 5 years after start of OL period
|
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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TV48574-IMM-20038
- 2022-002593-89 (Registrierungskennung: EudraCT (EU))
- 2024-515027-11-00 (Registrierungskennung: CTIS (EU))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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