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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513533-20-00 | Registry Identifier | EU CT | |
| U1111-1306-6970 | Registry Identifier | UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Low Dose Unblinded | Experimental | Participants receive a low dose subcutaneous (SC) tulisokibart regimen. |
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| Group 2: High Dose Unblinded | Experimental | Participants receive a high dose SC tulisokibart regimen. |
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| Group 3: High Dose Blinded | Experimental | Participants receive a blinded high dose SC tulisokibart regimen. |
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| Group 4: Low Dose Blinded | Experimental | Participants receive a blinded low dose SC tulisokibart regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulisokibart | Drug | Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score | 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. | Week 364 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Clinical Research Institute ( Site 0297) | Recruiting | Bristol | Connecticut | 06010 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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This extension study will enroll participants who choose to enter from certain studies in which they are already receiving treatment (their "parent studies"). They will enter the appropriate arm in this study that will provide the same treatment they had been receiving on their parent study.
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Participants in "Group 1: Low Dose Unblinded" and "Group 2: High Dose Unblinded" received open-label treatment on their parent studies, and will remain unblinded on this extension study.
Participants in "Group 3: High Dose Blinded" and "Group 4: Low Dose Blinded" were all blinded on their parent studies, and will remain blinded on this extension study until after regulatory approval or market authorization in the United States or European Medicines Agency, per sponsor discretion.
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| Placebo to tulisokibart | Drug | Placebo matching SC tulisokibart |
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| Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score |
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. |
| Week 364 |
| Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD) | 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. | Week 364 |
| Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS) | 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. | Week 364 |
| St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) | Recruiting | Ypsilanti | Michigan | 48197 | United States |
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| BVL Research - Kansas ( Site 0292) | Recruiting | Liberty | Missouri | 64068 | United States |
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| New York Gastroenterology Associates ( Site 0253) | Recruiting | New York | New York | 10075 | United States |
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| GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290) | Recruiting | Garland | Texas | 75044 | United States |
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| GI Alliance - Lubbock ( Site 0288) | Recruiting | Lubbock | Texas | 79410 | United States |
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| Caprock Gastro Research ( Site 0293) | Recruiting | Lubbock | Texas | 79424 | United States |
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| Southern Star Research Institute ( Site 0299) | Recruiting | San Antonio | Texas | 78229 | United States |
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| GI Alliance - Southlake ( Site 0298) | Recruiting | Southlake | Texas | 76092-9167 | United States |
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| Tyler Research Institute ( Site 0294) | Recruiting | Tyler | Texas | 75701 | United States |
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| University of Virginia Health System ( Site 0291) | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Washington Gastroenterology - Tacoma ( Site 0295) | Recruiting | Tacoma | Washington | 98405 | United States |
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| Vojenská Nemocnice Brno-Internal department ( Site 0701) | Recruiting | Brno | Brno-mesto | 615 00 | Czechia |
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| Hepato-Gastroenterologie HK ( Site 0700) | Recruiting | Hradec Králové | 50012 | Czechia |
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| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002) | Recruiting | Nice | Alpes-Maritimes | 06202 | France |
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| CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003) | Recruiting | Neuilly-sur-Seine | Hauts-de-Seine | 92200 | France |
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| CHRU De Nancy - Hopital de Brabois ( Site 1001) | Recruiting | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
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| Hopital Claude Huriez CHRU LILLE ( Site 1004) | Recruiting | Lille | Nord | 59037 | France |
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| ARENSIA Exploratory Medicine Georgia ( Site 1104) | Recruiting | Tbilisi | 0112 | Georgia |
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| Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411) | Recruiting | Békéscsaba | Bekes County | 5600 | Hungary |
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| Semmelweis Egyetem ( Site 1400) | Recruiting | Budapest | 1082 | Hungary |
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| Rivermed Sp. z.o.o. ( Site 2206) | Recruiting | Poznan | Greater Poland Voivodeship | 61-441 | Poland |
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| Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208) | Recruiting | Włocławek | Kuyavian-Pomeranian Voivodeship | 87-800 | Poland |
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| Krakowskie Centrum Medyczne ( Site 2210) | Recruiting | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
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| Centrum Medyczne Oporow ( Site 2212) | Recruiting | Wroclaw | Lower Silesian Voivodeship | 52-416 | Poland |
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| Melita Medical Sp. z o.o. ( Site 2204) | Active, not recruiting | Wroclaw | Lower Silesian Voivodeship | 53-611 | Poland |
| Przychodnia Futuremeds Wroclaw ( Site 2211) | Active, not recruiting | Wroclaw | Lower Silesian Voivodeship | 53-673 | Poland |
| 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205) | Recruiting | Lublin | Lublin Voivodeship | 20-059 | Poland |
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| Medrise Sp. z o.o. ( Site 2200) | Recruiting | Lublin | Lublin Voivodeship | 20-582 | Poland |
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| EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202) | Recruiting | Warsaw | Masovian Voivodeship | 00-189 | Poland |
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| Vivamed Sp. z o.o. ( Site 2201) | Recruiting | Warsaw | Masovian Voivodeship | 03-580 | Poland |
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| WIP Warsaw IBD Point Professor Kierkus ( Site 2209) | Recruiting | Warsaw | Masovian Voivodeship | 04-501 | Poland |
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| Vita Longa Sp. Zoo ( Site 2213) | Recruiting | Katowice | Silesian Voivodeship | 40-748 | Poland |
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| Sonomed Sp. z o. o. ( Site 2203) | Recruiting | Szczecin | West Pomeranian Voivodeship | 71-685 | Poland |
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| Bonifraterskie Centrum Medyczne ( Site 2207) | Recruiting | Lodz | Łódź Voivodeship | 93-357 | Poland |
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| Whipps Cross University Hospital ( Site 3400) | Active, not recruiting | London | England | E11 1NR | United Kingdom |
| MAC Research - Merseyside ( Site 3401) | Recruiting | Prescot | Knowsley | L34 1BH | United Kingdom |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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