Determination of the Optimal Treatment Target in Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis (UC); MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-002485-12-GB
• Lead Sponsor: Alimentiv Inc. (formerly Robarts Clinical Trials)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-30
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 660

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 561
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 99

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 result 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified