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Unknown
Active study drug for Ulcerative Colitis
Phase 1 & 2
Waitlist Available
Research Sponsored by Ore Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a documented diagnosis of mild to moderate Ulcerative Colitis, as demonstrated clinically and by endoscopy at Visit 2.
Baron score greater than or equal to 2 at baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 week
Awards & highlights
Study Summary
A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks. Study participants will be asked to visit clinic sites where they will be asked questions about their ulcerative colitis. Small samples of blood will be be drawn at study visits to monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at two times to determine whether the disease is getting better or worse.
Eligible Conditions
- Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events
Secondary outcome measures
Calprotectin concentrations
Change in the Ulcerative Colitis Clinical Score from Baseline
Change in the modified Baron Score from Baseline to Week 6
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active study drugExperimental Treatment1 Intervention
ORE1001 300 mg oral capsules
Group II: Placebo controlPlacebo Group1 Intervention
300 mg oral capsules containing placebo material
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Who is running the clinical trial?
Ore Pharmaceuticals, Inc.Lead Sponsor
Frequently Asked Questions
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