Ulcerative Colitis
Conditions
Brief summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.
Detailed description
This is a Phase 2, Proof of Concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate Ulcerative Colitis. The study will consist of 3 phases: * Screening Phase - up to 4 weeks * Double-blind Placebo-controlled Phase - Weeks 0 to 8 * Follow-up Phase - Week 9
Interventions
DRUGGED-0507-34-Levo 80 mg
GED-0507-34-Levo 80 mg BID for 8 Weeks
DRUGGED-0507-34-Levo 160 mg
GED-0507-34-Levo 160 mg BID for 8 Weeks
DRUGPlacebo
Placebo BID for 8 Weeks
Sponsors
PPM Services S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 and over at the time of signing the informed consent. * Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit. * MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study * Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit. * Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day
Exclusion criteria
* Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis. * UC restricted to the distal 15 cm or less (eg, ulcerative proctitis). * Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study. * Clinical signs suggestive of fulminant colitis or toxic megacolon. * Evidence of pathogenic enteric infection. * History of colorectal cancer or colorectal dysplasia. * Prior use of any TNF inhibitor (or any biologic agent). * Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide. * Use of budesonide-MMx within the last 8 weeks. * Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit. * Use of immunosuppressants (azathioprine \[AZA\], 6-mercaptopurine \[6-MP\] or methotrexate \[MTX\]) within 8 weeks of the Screening Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on Ulcerative Colitis Disease Activity Index | up to 8 Weeks | After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated. |
Countries
Bulgaria, Canada, France, Hungary, Italy, Latvia, Poland, Slovakia, Ukraine, United States
Participant flow
Recruitment details
First Patient IN: 28 November 2016 ; Last patient OUT: 31 July 2017
Pre-assignment details
The study consisted of 3 phases: * Screening Phase - up to 4 weeks * Double-blind Placebo-controlled Phase - Weeks 0 to 8 * Follow-up Phase - Week 9
Participants by arm
| Arm | Count |
|---|---|
| 80 mg BID GED-0507-34-Levo 80 mg BID for 8 Weeks
GED-0507-34-Levo 80 mg: GED-0507-34-Levo 80 mg BID for 8 Weeks | 4 |
| 160 mg BID GED-0507-34-Levo 160 mg BID for 8 Weeks
GED-0507-34-Levo 160 mg: GED-0507-34-Levo 160 mg BID for 8 Weeks | 8 |
| Placebo Placebo BID for 8 Weeks
Placebo: Placebo BID for 8 Weeks | 7 |
| Total | 19 |
Baseline characteristics
| Characteristic | 80 mg BID | 160 mg BID | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Not reported | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 4 participants | 7 participants | 6 participants | 17 participants |
| Sex/Gender, Customized Female | 2 participants | 3 participants | 5 participants | 10 participants |
| Sex/Gender, Customized Male | 2 participants | 5 participants | 2 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 4 | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 8 | 1 / 7 |
Outcome results
Primary
Efficacy on Ulcerative Colitis Disease Activity Index
After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated.
Time frame: up to 8 Weeks
Population: After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated