Udvidelsesundersøgelse af langsigtet sikkerhed og effektivitet af Tulisokibart hos deltagere med Crohns sygdom eller colitis ulcerosa (MK-7240-011)
Et fase 3 udvidelsesstudie for at evaluere den langsigtede sikkerhed og effektivitet af Tulisokibart hos deltagere med Crohns sygdom eller colitis ulcerosa
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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Knowsley
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Prescot, Knowsley, Det Forenede Kongerige, L34 1BH
- Rekruttering
- MAC Research - Merseyside ( Site 3401)
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Kontakt:
- Study Coordinator
- Telefonnummer: (0)151 482 4700
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Waltham Forest
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London, Waltham Forest, Det Forenede Kongerige, E11 1NR
- Aktiv, ikke rekrutterende
- Whipps Cross University Hospital ( Site 3400)
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Connecticut
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Bristol, Connecticut, Forenede Stater, 06010
- Rekruttering
- Connecticut Clinical Research Institute ( Site 0297)
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Kontakt:
- Study Coordinator
- Telefonnummer: 860-585-3000
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Michigan
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Ypsilanti, Michigan, Forenede Stater, 48197
- Rekruttering
- St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
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Kontakt:
- Study Coordinator
- Telefonnummer: 734-418-7736
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Missouri
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Liberty, Missouri, Forenede Stater, 64068
- Rekruttering
- BVL Research - Kansas ( Site 0292)
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Kontakt:
- Study Coordinator
- Telefonnummer: 816-222-4241
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New York
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New York, New York, Forenede Stater, 10075
- Rekruttering
- New York Gastroenterology Associates ( Site 0253)
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Kontakt:
- Study Coordinator
- Telefonnummer: 212-369-2490
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Texas
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Garland, Texas, Forenede Stater, 75044
- Rekruttering
- GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
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Kontakt:
- Study Coordinator
- Telefonnummer: 972-265-8201
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Lubbock, Texas, Forenede Stater, 79410
- Rekruttering
- GI Alliance - Lubbock ( Site 0288)
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Kontakt:
- Study Coordinator
- Telefonnummer: 806-793-3141
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Lubbock, Texas, Forenede Stater, 79424
- Rekruttering
- Caprock Gastro Research ( Site 0293)
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Kontakt:
- Study Coordinator
- Telefonnummer: 808-239-1823
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Southern Star Research Institute ( Site 0299)
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Kontakt:
- Study Coordinator
- Telefonnummer: 210-581-2812
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Southlake, Texas, Forenede Stater, 76092-9167
- Rekruttering
- GI Alliance - Southlake ( Site 0298)
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Kontakt:
- Study Coordinator
- Telefonnummer: 817-424-1525
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Tyler, Texas, Forenede Stater, 75701
- Rekruttering
- Tyler Research Institute ( Site 0294)
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Kontakt:
- Study Coordinator
- Telefonnummer: 903-630-6211
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Rekruttering
- University of Virginia Health System ( Site 0291)
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Kontakt:
- Study Coordinator
- Telefonnummer: 434-243-3090
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Washington Gastroenterology - Tacoma ( Site 0295)
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Kontakt:
- Study Coordinator
- Telefonnummer: 425-452-8547
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrig, 06202
- Rekruttering
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33 (0)4 92 03 93 66
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Hauts-de-Seine
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Neuilly-sur-Seine, Hauts-de-Seine, Frankrig, 92200
- Rekruttering
- CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33141430573
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrig, 54500
- Rekruttering
- CHRU De Nancy - Hopital de Brabois ( Site 1001)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33383157488
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Nord
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Lille, Nord, Frankrig, 59037
- Rekruttering
- Hopital Claude Huriez CHRU LILLE ( Site 1004)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33320445620
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Tbilisi, Georgien, 0112
- Rekruttering
- ARENSIA Exploratory Medicine Georgia ( Site 1104)
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Kontakt:
- Study Coordinator
- Telefonnummer: +995 599 133 071
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 61-441
- Rekruttering
- Rivermed Sp. z.o.o. ( Site 2206)
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Kontakt:
- Study Coordinator
- Telefonnummer: + 48 692 132 092
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Kuyavian-Pomeranian Voivodeship
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Włocławek, Kuyavian-Pomeranian Voivodeship, Polen, 87-800
- Rekruttering
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48542334000
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 31-501
- Rekruttering
- Krakowskie Centrum Medyczne ( Site 2210)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48124231722
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 52-416
- Rekruttering
- Centrum Medyczne Oporow ( Site 2212)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48717127077
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Wroclaw, Lower Silesian Voivodeship, Polen, 53-611
- Aktiv, ikke rekrutterende
- Melita Medical Sp. z o.o. ( Site 2204)
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Wroclaw, Lower Silesian Voivodeship, Polen, 53-673
- Aktiv, ikke rekrutterende
- Przychodnia Futuremeds Wroclaw ( Site 2211)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-059
- Rekruttering
- 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48882935706
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Lublin, Lublin Voivodeship, Polen, 20-582
- Rekruttering
- Medrise Sp. z o.o. ( Site 2200)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48572300747
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 03-580
- Rekruttering
- Vivamed Sp. z o.o. ( Site 2201)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48226792883
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Warsaw, Masovian Voivodeship, Polen, 04-501
- Rekruttering
- WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48500111648
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Warsaw, Masovian Voivodeship, Polen, 00-189
- Rekruttering
- EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48663097750
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polen, 40-748
- Rekruttering
- Vita Longa Sp. Zoo ( Site 2213)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48322029715
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polen, 71-685
- Rekruttering
- Sonomed Sp. z o. o. ( Site 2203)
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Kontakt:
- Study Coordinator
- Telefonnummer: +91 820 11 10
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polen, 93-357
- Rekruttering
- Bonifraterskie Centrum Medyczne ( Site 2207)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48 42 685 51 39
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Hradec Králové, Tjekkiet, 50012
- Rekruttering
- Hepato-Gastroenterologie HK ( Site 0700)
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Kontakt:
- Study Coordinator
- Telefonnummer: +420495218475
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Brno-mesto
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Brno, Brno-mesto, Tjekkiet, 615 00
- Rekruttering
- Vojenská Nemocnice Brno-Internal department ( Site 0701)
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Kontakt:
- Study Coordinator
- Telefonnummer: +420 973 445 520
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Budapest, Ungarn, 1082
- Rekruttering
- Semmelweis Egyetem ( Site 1400)
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Kontakt:
- Study Coordinator
- Telefonnummer: 3614591500/52120
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Bekes County
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Békéscsaba, Bekes County, Ungarn, 5600
- Rekruttering
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)
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Kontakt:
- Study Coordinator
- Telefonnummer: +36304366675
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
- The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
- A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
- A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
- A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)
Exclusion Criteria:
- Has prematurely discontinued study intervention in their parent study
- Has received any protocol-specified prohibited medications during their parent study
- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group 1: Low Dose Unblinded
Participants receive a low dose subcutaneous (SC) tulisokibart regimen. |
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Andre navne:
|
|
Eksperimentel: Group 2: High Dose Unblinded
Participants receive a high dose SC tulisokibart regimen. |
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Andre navne:
|
|
Eksperimentel: Group 3: High Dose Blinded
Participants receive a blinded high dose SC tulisokibart regimen. |
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Andre navne:
|
|
Eksperimentel: Group 4: Low Dose Blinded
Participants receive a blinded low dose SC tulisokibart regimen. |
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Andre navne:
Placebo matching SC tulisokibart |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 378 weeks
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
Up to approximately 378 weeks
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 364 weeks
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 364 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Tidsramme: Up to Week 364
|
The percentage of participants who enrolled in their parent study with Crohn's disease who achieve clinical remission, as defined by CDAI score <150, at Week 364 will be presented. |
Up to Week 364
|
|
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
Tidsramme: Up to Week 364
|
The percentage of participants who enrolled in their parent study with Crohn's disease achieving clinical remission at Week 364 per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline will be presented. |
Up to Week 364
|
|
Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
Tidsramme: Up to Week 364
|
The Simplified Endoscopic Score for Crohn's Disease (SES-CD) measures ileocolonoscopic findings in Crohn's Disease. Each segment of the ileo-colon (terminal ileum; ascending, transverse, and descending colon; rectum) is scored from 0 (normal or inactive disease) to 12 (severe disease; no more than one segment can have a score of 12, in which case the other 4 segments must each be ≤11), and the scores summed to produce an SES-CD ranging from 0 (overall least severe disease) to 56 (overall most severe disease). Endoscopic remission is defined as an SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable, as scored by central reader. |
Up to Week 364
|
|
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)
Tidsramme: Up to Week 364
|
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. |
Up to Week 364
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7240-011
- U1111-1306-6970 (Registry Identifier: UTN)
- 2024-513533-20-00 (Registry Identifier: EU CT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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