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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.
This is a Phase Ib/IIa prospective, multicenter, double blind, randomized, placebo controlled, clinical study to evaluate the safety, tolerability and pilot therapeutic activity of ORE1001, administered as capsules by mouth, for 6 weeks in subjects with Ulcerative Colitis.
Eligible subjects will be randomly assigned to either ORE1001 or placebo, respectively. Sigmoidoscopies with biopsies will be performed at the first treatment visit and week 6.
Subjects will be instructed to self-administer the study drug on an outpatient basis and will be scheduled to return for clinical evaluation on weeks 2, 4, 6 and between Weeks 10-12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active study drug | Experimental | ORE1001 300 mg oral capsules |
|
| Placebo control | Placebo Comparator | 300 mg oral capsules containing placebo material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORE1001 | Drug | Oral capsules containing 300 mg of the active, study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events | 6 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the modified Baron Score from Baseline to Week 6 | 6 Week | |
| Change in the Ulcerative Colitis Clinical Score from Baseline | 6 Week | |
| Change in the partial Mayo Score fom baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John F Reinhard, Ph.D. | Contact | (617) 250-8620 | jreinhard@orepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robarts Research Institute | Recruiting | London | Ontario | N6A5K8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19517214 | Background | Byrnes JJ, Gross S, Ellard C, Connolly K, Donahue S, Picarella D. Effects of the ACE2 inhibitor GL1001 on acute dextran sodium sulfate-induced colitis in mice. Inflamm Res. 2009 Nov;58(11):819-27. doi: 10.1007/s00011-009-0053-3. Epub 2009 Jun 11. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C486469 | 2-(1-carboxy-2-(3-(3,5-dichlorobenzyl)-3H-imidazol-4-yl)ethylamino)-4-methylpentanoic acid |
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| Placebo | Drug | placebo capsules |
|
|
| 6 week |
| Calprotectin concentrations | 6 week |
| Riley Acute Inflammation Scale (histology) | 6 week |
| Clinical remission | Week 6 |
| Dr, Bhatnagar's Clinic | Recruiting | Ahmedabad | Gujarat | 380009 | India |
|
| Vikram Jyoth Centre for Advanced Gastroenterology | Recruiting | Mysore | Karnataka | 570002 | India |
|
| St. John's Medical College Hospital | Recruiting | Bangalore | Karnatka | 560034 | India |
|
| Gut-n-HEPA Care | Recruiting | Indore | Madhya Pradesh | 452001 | India |
|
| Amol Gastroenterology Hospital | Recruiting | Indore | Madhya Pradesh | 452003 | India |
|
| B.Y.L. Nair Hospital | Recruiting | Bombay | Maharashtra | 400008 | India |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |