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Trial Outcomes & Findings for Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC (NCT NCT02808390)

NCT ID: NCT02808390

Last Updated: 2018-11-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

up to 8 Weeks

Results posted on

2018-11-27

Participant Flow

First Patient IN: 28 November 2016 ; Last patient OUT: 31 July 2017

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

Participant milestones

Participant milestones
Measure
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
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
Placebo
Placebo BID for 8 Weeks Placebo: Placebo BID for 8 Weeks
Overall Study
STARTED
4
8
7
Overall Study
COMPLETED
2
2
4
Overall Study
NOT COMPLETED
2
6
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
80 mg BID
n=4 Participants
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
160 mg BID
n=8 Participants
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
Placebo
n=7 Participants
Placebo BID for 8 Weeks Placebo: Placebo BID for 8 Weeks
Total
n=19 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=93 Participants
8 Participants
n=4 Participants
7 Participants
n=27 Participants
19 Participants
n=483 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Sex/Gender, Customized
Female
2 participants
n=93 Participants
3 participants
n=4 Participants
5 participants
n=27 Participants
10 participants
n=483 Participants
Sex/Gender, Customized
Male
2 participants
n=93 Participants
5 participants
n=4 Participants
2 participants
n=27 Participants
9 participants
n=483 Participants
Race/Ethnicity, Customized
White
4 participants
n=93 Participants
7 participants
n=4 Participants
6 participants
n=27 Participants
17 participants
n=483 Participants
Race/Ethnicity, Customized
Black or African American
0 participants
n=93 Participants
1 participants
n=4 Participants
0 participants
n=27 Participants
1 participants
n=483 Participants
Race/Ethnicity, Customized
Not reported
0 participants
n=93 Participants
0 participants
n=4 Participants
1 participants
n=27 Participants
1 participants
n=483 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome data not reported

Adverse Events

80 mg BID

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

160 mg BID

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
80 mg BID
n=4 participants at risk
GED-0507-34-Levo 80 mg BID
160 mg BID
n=8 participants at risk
GED-0507-34-Levo 160 mg BID
Placebo
n=7 participants at risk
Placebo treatment
Gastrointestinal disorders
Colitis ulcerative
0.00%
0/4 • 8 weeks
0.00%
0/8 • 8 weeks
14.3%
1/7 • Number of events 1 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Salvatore Bellinvia

PPM Services

Phone: +41916961710

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place