Determination of the Optimal Treatment Target in Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Nov 9, 2024
  • participants needed
    660
  • sponsor
    Alimentiv Inc.
Updated on 9 November 2021
corticosteroids
remission
tumor necrosis factor
vedolizumab
hematochezia

Summary

Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development.

Participants with active UC will be randomized in a 2:3:5 ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as:

  • Group 1: corticosteroid-free symptomatic remission
  • Group 2: corticosteroid-free endoscopic + symptomatic remission
  • Group 3: corticosteroid-free histological + endoscopic + symptomatic remission

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Treatment Algorithm A, Treatment Algorithm B, Treatment Algorithm C
Clinical Study IdentifierNCT04259138
SponsorAlimentiv Inc.
Last Modified on9 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria
Moderately to severely active UC with a Mayo rectal bleeding subscore 1 and a Mayo endoscopic subscore (MES) 2, with minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using central endoscopic imaging system
Ability of subject to participate fully in all aspects of this clinical trial
Written informed consent must be obtained and documented
Agree not to participate in an investigational trial for the duration of the trial (observation trials without investigational product may be permitted at the discretion of the investigator)
Willing to perform a standard of care tuberculosis (TB) test and hepatitis B and C test prior to starting any biologic drug during the study, unless negative results available from within 12 months prior
A male subject who is nonsterilized _and sexually active with a female partner of childbearing potential_ agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose
A female subject of childbearing potential who is sexually active with a nonsterilized _male partner agrees to use routinely adequate contraception_ from signing of informed consent throughout the duration of the study and for 18 weeks after last dose
Up to date with colorectal carcinoma surveillance according to local standards and guidelines. If a subject is not up to date at screening, a standard of care surveillance assessment may be performed during the screening period
Subjects who are not responding to their existing treatment for UC (Netherlands-specific criterion)

Exclusion Criteria

Subjects who have historically failed (i.e., had an inadequate response with, lost response to, or were intolerant to) 2 or more compounds or classes of advanced therapeutic options (biologics or small molecules; e.g., anti-TNFs, ustekinumab, or tofacitinib) for the treatment of their UC
Current or previous treatment with vedolizumab, ertrolizumab, or natalizumab
Topical therapy (corticosteroid or 5-aminosalicylate [5-ASA]) use within 2 weeks prior to screening endoscopy
Change to oral corticosteroid dosing within 2 weeks prior to screening
Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis
Short gut syndrome
Positive stool culture for or active Clostridioides difficile infection (as demonstrated by positive toxin and/or antigen)
Known hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required
Received any investigational drug within 30 days prior to randomization/target assignment
Known active or latent TB. If a negative test results is available in the 12 months prior to randomization, confirmatory testing is not required
Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, or any unstable or uncontrolled medical disorder)
History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures
The subject has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization
Hypersensitivity to any excipient of vedolizumab
Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection
History of HIV or positive test at screening (Italy-specific criterion)
Any other contraindication(s)to vedolizumab (Italy-specific criterion)
If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after the last dose; or intending to donate ova during such time period
If male, the subject intends to donate sperm during the course of this study or for 18 weeks after the last dose
Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination during conduct of the study, except vaccination for coronavirus disease of 2019 (COVID 19)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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