VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target

Phase 4

Withdrawn

Conditions: Ulcerative colitis
10017969
Chronic inflammatory bowl disease

Registration Number: NL-OMON49621

Lead Sponsor: Robarts Clinical Trials

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

Subjects must meet each of the following criteria for enrollment into the study:
1. Age * 18 years
2. Diagnosis of UC confirmed by clinical, endoscopic, and histopathological
evidence prior to screening as per standard criteria
3. 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
4. Ability of subject to participate fully in all aspects of this clinical trial
5. Written informed consent must be obtained and documented
6. 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)
7. Negative standard of care tuberculosis (TB) test and hepatitis B and C test
prior to
randomization, unless negative results available from within 12 months prior
8. 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
9. 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
10. 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.

Exclusion Criteria

Subjects who exhibit any of the following conditions are ineligible for the
study:
1. 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
2. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab
3. Topical therapy (corticosteroid or 5-aminosalicylate [5-ASA]) use within 2
weeks prior to screening endoscopy
4. Change to oral corticosteroid dosing within 2 weeks prior to randomization
or a corticosteroid dose of > 30 mg of prednisone or equivalent at
randomization
5. Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation
colitis, diverticular disease associated with colitis, or microscopic colitis
6. Short gut syndrome
7. Positive stool culture for or known C. difficile infection
8. Pregnant women
9. Known hepatitis B or C infection. If a negative test result is available in
the 12 months prior to randomization, retesting is not required
10. Known active or latent TB. If a negative test results is available in the
12 months prior to randomization, confirmatory testing (per standard of care)
is not required before randomization
11. Received any investigational drug within 30 days prior to enrollment/target
assignment
12. 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)
13. 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
14. The subject has active cerebral/meningeal disease, signs, symptoms, or any
history of progressive multifocal leukoencephalopathy (PML) prior to
randomization
15. Hypersensitivity to any excipient of vedolizumab
16. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or
opportunistic infection.