Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPRX-106 2 mg | Experimental | Open label, 1:1 randomization ration (up to 10 subjects) |
|
| OPRX-106 8 mg | Experimental | Open label, 1:1 randomization ration (up to 10 subjects) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPRX-106 | Drug | Oral delivery, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events following daily administration of OPRX 106 | Adverse events from subject reporting or other assessments | 70 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| OPRX-106 individual plasma levels following single and multiple dose administrations | 56 days | |
| Clinical response or clinical remission from baseline to end of OPRX 106 treatment | Based on Mayo score | Baseline to day 56 |
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Einat Dekel, DVM | Contact | Einat.Dekel@protalix.com |
| Name | Affiliation | Role |
|---|---|---|
| Einat Dekel, DVM | Sr. Director Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Hospital | Recruiting | Beersheba | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Histopathological improvement (Geboes scale) from baseline to end of OPRX treatment | Baseline to day 56 |
| Improvement from baseline to end of OPRX 106 treatment in hs-CRP levels | Baseline to day 56 |
| Improvement from baseline to end of OPRX 106 treatment in fecal calprotectin levels | Baseline to day 56 |
| Rambam Health Care Campus | Recruiting | Haifa | Israel |
|
| Hadassah Medical Center | Not yet recruiting | Jerusalem | Israel |
|
| Shaare-Zedek Medical Center | Not yet recruiting | Jerusalem | Israel |
|
| Galilee Medical Center | Not yet recruiting | Nahariya | Israel |
|
| Assaf-Harofeh Medical Center | Not yet recruiting | Rishon LeZiyyon | Israel |
|
| Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |