A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

• Conditions: Mild to Moderate Ulcerative Colitis; MedDRA version: 16.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-003974-18-BG
• Lead Sponsor: Vascular Biogenics Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-07
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Fully understand all elements of and have signed and dated the written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures;
2. Male or female, =18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening;
3. A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC (if not previously obtained, biopsies should be done as part of screening endoscopy);
4. Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization;
5. Modified Mayo score of 4 to 10 points (mild to moderate) and Mayo endoscopic score of at least 2 to be confirmed by Central Reader endoscopy video;
6. Active UC despite previous treatment with at least one 5-aminosalicylic acid (5-ASA) compound at a dose of =2000 mg/day for at least 4 weeks or documented intolerance to such therapy;
7. For a female subject; either: - subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oophorectomy
OR
- agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug;
Male subject must use at least one method of contraception (e.g., condom);
8. In the opinion of the Investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.
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 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Diagnosis of indeterminate colitis, Crohn’s disease, or clinical findings suggestive of Crohn’s disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis);
2. Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
3. History of dysplasia on colonic biopsy;
Subject with = 8 year history of pancolitis or = 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year. If the subject has not had this procedure within the past year, the subject will be required to have a colonoscopy rather than flexible sigmoidoscopy at Screening;
5. Subject = 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years. The subject will be required to have a colonoscopy rather than flexible sigmoidoscopy at Screening;
6. Subject who has had any prior surgical resection of any part of the colon excluding the appendix;
7. Subject who has been hospitalized for a UC-related event within 30 days prior to Screening;
8. Subject who received any investigational drug within 30 days or five half-lives of Screening;
9. Previous participation in a VB-201 study;
10. Previous treatment with any biologic product including investigational biologic products within one year prior to baseline visit;
11. Concomitant and prior medications: subjects should be excluded if they are taking:
- Systemic corticosteroids unless they have been on a stable dose of one of the following for at least 4 weeks prior to the Baseline Visit:
• Prednisone up to 20 mg/day or equivalent
• Budesonide up to 9 mg/day
If recently discontinued, must have stopped at least 4 weeks prior to the Baseline Visit;
- Azathioprine/6-mercaptopurine/methotrexate unless the subject has been on such treatment for at least 4 months prior to the Baseline Visit and at a stable dose for at least 8 weeks prior to the Baseline Visit. If recently discontinued, the subject must have stopped at least 4 weeks or 5 half-lives prior to the Baseline Visit;
- Any other immunosuppressants (e.g. tacrolimus, cyclosporine, mycophenolate mofetil, or leflunomide). If recently discontinued, the subject must have stopped at least 4 weeks or 5 half-lives (which ever is greatest) prior to the Baseline Visit;
- Oral 5-ASA compounds unless the subject has been on a stable dose at least 4 weeks prior to the Baseline Visit. If recently discontinued, the subject must have stopped at least 4 weeks prior to the Baseline Visit;
- Rectally administered corticosteroids or 5-ASA are excluded for at least 14 days prior to the Baseline Visit and throughout the study;
- Antibiotics for the treatment of UC within 14 days of the Baseline Visit and throughout the study (Exception: antibiotics are permitted to treat infections outside of the gastrointestinal tract);
- Probiotics within 14 days of the Baseline Visit and throughout the study.
12. The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit (if initially positive, subjects treated for C. difficile may be re-screened once);
13. The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigato

Study & Design

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