Determination of the Optimal Treatment Target in Ulcerative Colitis

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72
participants needed

660
sponsor

Robarts Clinical Trials Inc.

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Updated on 19 February 2024

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remission

corticosteroids

colitis

tuberculosis

ulcerative colitis

hepatitis b

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
Age	18-100 years
Treatment	Treatment Algorithm A, Treatment Algorithm B, Treatment Algorithm C
Clinical Study Identifier	NCT04259138
Sponsor	Robarts Clinical Trials Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Diagnosis of UC confirmed by clinical, endoscopic, and histopathological evidence prior to screening as per standard criteria
	Moderately to severely active UC with a Mayo rectal bleeding subscore 1 and a 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
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 C. difficile infection (as demonstrated by positive toxin and/or antigen)
	Pregnant women
	Subjects with hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required
	Subjects who have active or latent TB. If a negative test results 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
	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

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Determination of the Optimal Treatment Target in Ulcerative Colitis