NCT01839214

Brief Summary

This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

April 21, 2013

Last Update Submit

March 26, 2015

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Modified Mayo Score indicating remission

    The proportion of subjects in remission at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.

    Week 12 and Week 24

Secondary Outcomes (1)

  • Modified Mayo Score indicating response

    Week 12 and Week 24

Other Outcomes (4)

  • Frequency of Adverse Events

    From Baseline through safety follow up at Week 28

  • Reduction in Modified Mayo Score

    Week 12 and Week 24

  • Modified Baron Score

    Week 12 and Week 24

  • +1 more other outcomes

Study Arms (2)

VB-201 160mg

EXPERIMENTAL

Subjects will received 80mg twice daily for 24 weeks.

Drug: VB-201 160mg

Placebo with crossover to VB-201 160mg

PLACEBO COMPARATOR

Subjects on placebo will crossover to VB-201 160 at week 12.

Drug: VB-201 160mgDrug: Placebo

Interventions

VB-201 160mgDRUG
Placebo with crossover to VB-201 160mgVB-201 160mg
PlaceboDRUG
Placebo with crossover to VB-201 160mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening
  • A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC
  • Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
  • Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
  • Active UC despite previous treatment with at least one 5-ASA compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy

You may not qualify if:

  • 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)
  • Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
  • 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
  • Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years
  • Subject who has had any prior surgical resection of any part of the colon excluding the appendix
  • Previous treatment with any biologic product including investigational biologic products within 1 year prior to baseline visit
  • The subject is taking Systemic corticosteroids, Azathioprine/6-mercaptopurine/methotrexate, immunosuppressants, Oral 5-ASA compounds unless they have been on a stable dose of sufficient duration prior to Baseline. If recently discontinued the subject must have had a wash-out periods of sufficient duration prior to Baseline
  • Rectally administered corticosteroids or 5-ASA, antibiotics for the treatment of UC and probiotics within 14 days of the Baseline Visit and throughout the study
  • The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit
  • Presence of, or history of cancer, with the exception of skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VBL Investigative Site

Sofia, Bulgaria

Location

VBL Investigative Site

Szombathely, Hungary

Location

VBL Investigative Site

Warsaw, Poland

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2013

First Posted

April 24, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

BU(1)PL(1)HU(1)