Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

NCT06651281
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,380
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2024-11-25
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Number of sites
37
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Summary
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.
clinicaltrials.gov
Short title
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
clinicaltrials.gov
Official title
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2037-12-17
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First posted
2024-10-21
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Registry last updated
2026-05-19
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Primary completion date
2037-12-17
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Start date
2024-11-25
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Participants
1,380
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Participant count basis
Estimated
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Planned participants
1,380
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Protocol amendments
2
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Number of sites
37
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06651281
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ClinicalTrials.gov ID
NCT06651281
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
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.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Number of Participants Who Experience an Adverse Event (AE)

    Timeframe: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Timeframe: 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.

  1. Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score

    Timeframe: 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.

  2. Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score

    Timeframe: 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.

  3. Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)

    Timeframe: 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.

  4. Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Healthy volunteers
No

  • 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)

  • 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
Sources for eligibility
clinicaltrials.gov

  • Connecticut Clinical Research Institute ( Site 0297)Bristol, United StatesRecruiting
  • St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)Ypsilanti, United StatesRecruiting
  • BVL Research - Kansas ( Site 0292)Liberty, United StatesRecruiting
  • New York Gastroenterology Associates ( Site 0253)New York, United StatesRecruiting
  • GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)Garland, United StatesRecruiting
  • GI Alliance - Lubbock ( Site 0288)Lubbock, United StatesRecruiting
  • Caprock Gastro Research ( Site 0293)Lubbock, United StatesRecruiting
  • Southern Star Research Institute ( Site 0299)San Antonio, United StatesRecruiting
  • GI Alliance - Southlake ( Site 0298)Southlake, United StatesRecruiting
  • Tyler Research Institute ( Site 0294)Tyler, United StatesRecruiting
  • University of Virginia Health System ( Site 0291)Charlottesville, United StatesRecruiting
  • Washington Gastroenterology - Tacoma ( Site 0295)Tacoma, United StatesRecruiting
  • Vojenská Nemocnice Brno-Internal department ( Site 0701)Brno, CzechiaRecruiting
  • Hepato-Gastroenterologie HK ( Site 0700)Hradec Králové, CzechiaRecruiting
  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)Nice, FranceRecruiting
  • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)Neuilly-sur-Seine, FranceRecruiting
  • CHRU De Nancy - Hopital de Brabois ( Site 1001)Vandœuvre-lès-Nancy, FranceRecruiting
  • Hopital Claude Huriez CHRU LILLE ( Site 1004)Lille, FranceRecruiting
  • ARENSIA Exploratory Medicine Georgia ( Site 1104)Tbilisi, GeorgiaRecruiting
  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)Békéscsaba, HungaryRecruiting
  • Semmelweis Egyetem ( Site 1400)Budapest, HungaryRecruiting
  • Rivermed Sp. z.o.o. ( Site 2206)Poznan, PolandRecruiting
  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)Włocławek, PolandRecruiting
  • Krakowskie Centrum Medyczne ( Site 2210)Krakow, PolandRecruiting
  • Centrum Medyczne Oporow ( Site 2212)Wroclaw, PolandRecruiting

And 12 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1306-6970
  • 2024-513533-20-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)