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Evaluate Efficacy & Safety of Tulisokibart in Participants w Moderately to Severely Active Crohns

UCI Specialty Area: Gastroenterology
Principal Investigator: Sandra Park
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn's Disease
A Study On:
Crohns Disease
Digestive - Gastrointestinal

Study Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Eligibility

  1. Has had a diagnosis of CD at least 3 months before study.
  2. Has moderately to severely active CD.
  3. Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
  4. Adolescent participants greater than or equal to 16 and less than 18 years of age can participate if approved by the country or regulatory/health authority.
  1. Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
  2. Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
  3. Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  4. Has current stoma or need for colostomy or ileostomy.
  5. Is missing greater than 2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
  6. Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
  7. Has surgical bowel resection within 3 months of study.
  8. Has prior or current gastrointestinal dysplasia.
  9. Has chronic infection requiring ongoing antimicrobial treatment.
  10. Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
  11. Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  12. Has active tuberculosis.
  13. Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
  14. Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
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    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI