Clinical Trial Results:
A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS
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Summary
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EudraCT number |
2011-003283-78 |
Trial protocol |
IT |
Global end of trial date |
18 Dec 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Feb 2016
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First version publication date |
14 Feb 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GED-0507-01-11
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Giuliani SpA
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Sponsor organisation address |
Via Palagi 2, Milan, Italy,
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Public contact |
PHARMA DIVISION, GIULIANI S.P.A., +39 02 2054208,
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Scientific contact |
PHARMA DIVISION, GIULIANI S.P.A., +39 02 2054208,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Apr 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Dec 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy of GED-0507-34-Levo in patients with active ulcerative colitis defined as the percentage of patients in remission at Week 8 (after 8 weeks of treatment). The Remission is defined as Ulcerative Colitis Disease Activity Index (UC-DAI)≤ 1 with a score of 0 for rectal bleeding and stool frequency and at least a 1 point reduction from Baseline in the sigmoidoscopy score.
To assess the safety and tolerability of GED-0507-34-Levo 160 mg/day.
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Protection of trial subjects |
Subjects were free to withdraw from the study at any time for any reason without prejudice to
their future medical care by the physician or at the institution. The investigator or Giuliani SpA
could also have withdrawn a subject at any time in the interest of subject safety.
The primary reason for withdrawal was recorded in the subject’s medical records and on the
withdrawal form in the case report form (CRF).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jan 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 38
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Worldwide total number of subjects |
38
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EEA total number of subjects |
38
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
36
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
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Pre-assignment
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Screening details |
Subj. screened within max 7 days to determ. eligibility prior to first dose of IMP.Following info collected & following procedures performed: IC;Check incl.&excl. criteria;Dem.&habits data;MH;CM;Physical exam.;Vital signs;B W;ECG;Haemat.&biochem, ;Urine sampl.;Urine preg Test; Stool culture; Drug & alcohol screening | ||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Single-arm (GED-0507-34-Levo 160mg) | ||||||||||
Arm description |
GED-0507-34-Levo was supplied for oral administration as tablets of 80 mg of active ingredient. Dosage was 80 mg/person twice a day (total dose 160 mg/person/day) administered orally. Total treatment duration was 8 weeks for each patient. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
GED-0507-34-Levo 80mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gastro-resistant tablet
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Routes of administration |
Oral use
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Dosage and administration details |
GED-0507-34-Levo was supplied for oral administration as tablets of 80 mg of active ingredient
Dosage was 80 mg/person twice a day (total dose 160 mg/person/day) administered orally.
Total treatment duration was 8 weeks for each patient.
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Baseline characteristics reporting groups
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Reporting group title |
Single-arm (GED-0507-34-Levo 160mg)
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Reporting group description |
GED-0507-34-Levo was supplied for oral administration as tablets of 80 mg of active ingredient. Dosage was 80 mg/person twice a day (total dose 160 mg/person/day) administered orally. Total treatment duration was 8 weeks for each patient. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
mITT
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Modified Intent-to treat (mITT) population is defined as the ITT population with the exclusion of the subjects who: a) withdraw from the study due to a reason clearly documented as independent of treatment; b) remained on study for less than 3 days. More specifically, subjects withdrawing from the study for the above reasons will be excluded from the mITT, while all other withdrawals will be counted as failures (i.e. reasons potentially correlated with lack of efficacy).
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Subject analysis set title |
PP
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The per-protocol (PP) population is defined as all patients in the mITT population with no major protocol violations. A major protocol violation is defined as a deviation likely to significantly affect treatment efficacy. These violations will be detailed in the SAP
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End points reporting groups
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Reporting group title |
Single-arm (GED-0507-34-Levo 160mg)
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Reporting group description |
GED-0507-34-Levo was supplied for oral administration as tablets of 80 mg of active ingredient. Dosage was 80 mg/person twice a day (total dose 160 mg/person/day) administered orally. Total treatment duration was 8 weeks for each patient. | ||
Subject analysis set title |
mITT
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
The Modified Intent-to treat (mITT) population is defined as the ITT population with the exclusion of the subjects who: a) withdraw from the study due to a reason clearly documented as independent of treatment; b) remained on study for less than 3 days. More specifically, subjects withdrawing from the study for the above reasons will be excluded from the mITT, while all other withdrawals will be counted as failures (i.e. reasons potentially correlated with lack of efficacy).
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Subject analysis set title |
PP
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol (PP) population is defined as all patients in the mITT population with no major protocol violations. A major protocol violation is defined as a deviation likely to significantly affect treatment efficacy. These violations will be detailed in the SAP
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End point title |
Percentage of patients in remission (defined as patients with UC-DAI score ≤1 with a score of 0 for rectal bleeding and stool frequency and at least a 1 point reduction from baseline in the sigmoidocopy score) at W 8 (after 8 W of study drug treatment) | ||||||||||||
End point description |
End point value units (countable) refer to number of subjects
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End point type |
Primary
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End point timeframe |
Assessments of UC-DAI scores were performed from Baseline to each timepoint: Week 2; Week 4; Week 8
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Statistical analysis title |
Fleming design, open, single stage | ||||||||||||
Statistical analysis description |
If remission was≥40 %, GED-0507-34-Levo at 160 mg/day for 8 weeks can be assessed as effective for induction of remission in active UC.Based on Fleming’s Design, this conclusion is achieved when the N of remissions at week 8 was ≥11. If number of remissions ≥11,the hypothesis that P ≤ 20% was rejected with a target error rate of 0.10 and the drug considered efficacious; on the contrary, if the number of remissions ≤ is 10, the hypothesis that P ≥ 40% was rejected with a target error rate of 0.10
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Comparison groups |
Single-arm (GED-0507-34-Levo 160mg) v mITT
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Number of subjects included in analysis |
72
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
< 0.05 [2] | ||||||||||||
Method |
Fleming Design | ||||||||||||
Parameter type |
Fleming Design | ||||||||||||
Confidence interval |
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| Notes [1] - Fleming design, open, single stage [2] - In tthe Fleming Design, Open, Single Stage Model the p value is NA |
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Adverse events information
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Timeframe for reporting adverse events |
Assessment of any adverse events occured was made firstly by the Investigators during the planned Trial Control Visits. In particular, at Baseline (Day of Randomization), Visit 3 (Week 2) , Visit 4 (Week 4) Visit 5 (end of study/early withdrawal/Week 8)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Safety Population
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Reporting group description |
All subjects who received at least one dose of the treatment GED-0507-34-Levo 160mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
