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Clinical Trial Results:
A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn‟s disease (Ileo-Colitis)

Summary
EudraCT number	2011-002640-27
Trial protocol	IT DE
Global end of trial date	30 Sep 2013

Results information
Results version number	v1(current)
This version publication date	14 Feb 2016
First version publication date	14 Feb 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GED-301-01-11

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Giuliani S.P.A.

Sponsor organisation address

Via Palagi 2, Milano, Italy,

Public contact

PHARMA DIVISION, GIULIANI S.P.A., +39 02 20541,

Scientific contact

PHARMA DIVISION, GIULIANI S.P.A., +39 02 20541,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

24 Nov 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

30 Sep 2013

Was the trial ended prematurely?

Main objective of the trial

a. Efficacy: the primary efficacy endpoint was the percentage of patients in remission defined as CDAI < 150 at day 15 (after 14 days of study drug treatment) which is maintained at Week 4. b. Evaluation of safety of GED-0301, 14-day oral administration.

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 The investigator or Giuliani SpA could also have withdrawn a subject at any time in the interest of subject safety.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).

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Jul 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 5

Country: Number of subjects enrolled

Italy: 161

Worldwide total number of subjects

166

EEA total number of subjects

166

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

159

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Subj. screened within max 9 days to determ. eligibility prior to first dose of IMP or placebo.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, incl. CRP;Ileocolon.;Urine sampl.;Oligo class effect sampl;Urine preg Test;Disp. CDAI quest

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

10mg

Arm description

GED-0301 10 mg

Arm type

Experimental

Investigational medicinal product name

GED-0301 10mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Gastro-resistant tablet

Routes of administration

Oral use

Dosage and administration details

1 x GED-0301 10 mg tablet once daily for 14 days

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Gastro-resistant tablet

Routes of administration

Oral use

Dosage and administration details

3x Placebo tablets once daily for 14 days

40mg

Arm description

GED-0301 40mg

Arm type

Experimental

Investigational medicinal product name

GED-0301 40mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Gastro-resistant tablet

Routes of administration

Oral use

Dosage and administration details

1x GED-0301 40mg tablet once daily for 14 days

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Gastro-resistant tablet

Routes of administration

Oral use

Dosage and administration details

3 x Placebo tablets once daily for 14 days

160mg

Arm description

GED-0301 160mg

Arm type

Experimental

Investigational medicinal product name

GED-0301 40mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Gastro-resistant tablet

Routes of administration

Oral use

Dosage and administration details

4 x GED-0301 40mg tablets once daily for 14 days

Placebo

Arm description

Placebo

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Gastro-resistant tablet

Routes of administration

Oral use

Dosage and administration details

4 x Placebo tablets once daily for 14 days

Number of subjects in period 1	10mg	40mg	160mg	Placebo
Started	41	40	43	42
Completed	32	37	39	30
Not completed	9	3	4	12
Consent withdrawn by subject	1	-	-	1
Adverse event, non-fatal	5	2	1	8
Lost to follow-up	2	-	-	1
Lack of efficacy	1	1	1	-
Protocol deviation	-	-	2	2

Baseline characteristics

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Reporting group title

overall trial

Reporting group description

Reporting group values	overall trial	Total
Number of subjects	166	166
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	159	159
From 65-84 years	7	7
85 years and over	0	0
Gender categorical
Units: Subjects
Female	85	85
Male	81	81

End points

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Reporting group title

10mg

Reporting group description

GED-0301 10 mg

Reporting group title

40mg

Reporting group description

GED-0301 40mg

Reporting group title

160mg

Reporting group description

GED-0301 160mg

Reporting group title

Placebo

Reporting group description

Placebo

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

Comprised all randomized subjects who received at least 1 dose of the IP.

Primary: The primary efficacy endpoint was the percentage of subjects in remission, defined as CDAI < 150, at Day 15 (Week 2) (after 14 days of study drug treatment), which is maintained at Week 4.

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End point title

The primary efficacy endpoint was the percentage of subjects in remission, defined as CDAI < 150, at Day 15 (Week 2) (after 14 days of study drug treatment), which is maintained at Week 4.

End point description

End point value units (countable) refer to number of subjects

End point type

Primary

End point timeframe

Assessments of CDAI scores were performed from Baseline to each time point: Day 15, Day 28 and Day 84

End point values	10mg	40mg	160mg	Placebo
Number of subjects analysed	41	40	43	42
Units: Countable	5	22	28	4

Main Analysys

Statistical analysis description

For % endpoints, null hypothesis was that the % were the same in the PL and the of GED0301 arms; the alternative was that % differ.Chi-square test (or Fisher’s exact test) to evaluate the difference in the proportion of patients in clinical remission applied.The analysis considers subjects with unknown status as not experienced remission.If a stat.sign.diff. among 3 GED-0301 groups existed,a Chi-square for trend (Cochran-Armitage test) applied to assess for presence of a linear trend among doses

Comparison groups

10mg v 40mg v 160mg v Placebo

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

superiority

P-value

≤ 0.05

Method

Fisher exact

Confidence interval

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at Week 2

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End point title

Proportion of Subjects Who Attained a 100-point Clinical Response at Week 2

End point description

End point value units (countable) refer to number of subjects

End point type

Secondary

End point timeframe

Day 15 versus Baseline

End point values	10mg	40mg	160mg	Placebo
Number of subjects analysed	41	40	43	42
Units: Countable	9	18	28	11

No statistical analyses for this end point

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at week 4

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End point title

Proportion of Subjects Who Attained a 100-point Clinical Response at week 4

End point description

End point value units (countable) refer to number of subjects

End point type

Secondary

End point timeframe

Day 28 versus Baseline

End point values	10mg	40mg	160mg	Placebo
Number of subjects analysed	41	40	43	42
Units: Countable	15	23	31	7

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

The assessment of any adverse event occured was made firstly by the Investigators during the planned Trial Control Visits. In particular, at Day1 (Day of Randomization), Day 14 (End of Treatment Visit), Day 28 (Follow-Up Visit)and Day 84 (Follow-Up Visit)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

10 mg

Reporting group description

GED-0301 10 mg

Reporting group title

40mg

Reporting group description

GED-0301 40mg

Reporting group title

160mg

Reporting group description

GED-0301 160mg

Reporting group title

Placebo

Reporting group description

Placebo

Serious adverse events	10 mg	40mg	160mg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 41 (7.32%)	1 / 40 (2.50%)	1 / 43 (2.33%)	1 / 42 (2.38%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Thermal burn
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 43 (2.33%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 43 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 41 (4.88%)	0 / 40 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	1 / 41 (2.44%)	0 / 40 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 43 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	0 / 41 (0.00%)	1 / 40 (2.50%)	0 / 43 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 43 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	10 mg	40mg	160mg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	20 / 41 (48.78%)	25 / 40 (62.50%)	21 / 43 (48.84%)	28 / 42 (66.67%)
Investigations
C-reactive protein increased
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	4 / 43 (9.30%)	4 / 42 (9.52%)
occurrences all number	0	0	4	4
Nervous system disorders
Headache
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 43 (0.00%)	3 / 42 (7.14%)
occurrences all number	0	0	0	3
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	3 / 41 (7.32%)	0 / 40 (0.00%)	0 / 43 (0.00%)	4 / 42 (9.52%)
occurrences all number	3	0	0	4
Gastrointestinal disorders
Crohn's disease
subjects affected / exposed	6 / 41 (14.63%)	4 / 40 (10.00%)	5 / 43 (11.63%)	13 / 42 (30.95%)
occurrences all number	6	4	5	13
Abdominal pain
subjects affected / exposed	4 / 41 (9.76%)	4 / 40 (10.00%)	5 / 43 (11.63%)	5 / 42 (11.90%)
occurrences all number	4	4	5	5
Abdominal mass
subjects affected / exposed	0 / 41 (0.00%)	3 / 40 (7.50%)	3 / 43 (6.98%)	0 / 42 (0.00%)
occurrences all number	0	3	3	0
Diarrhoea
subjects affected / exposed	0 / 41 (0.00%)	0 / 40 (0.00%)	3 / 43 (6.98%)	0 / 42 (0.00%)
occurrences all number	0	0	3	0
Infections and infestations
Cystitis
subjects affected / exposed	3 / 41 (7.32%)	0 / 40 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)
occurrences all number	3	0	0	0
Urinary tract infection
subjects affected / exposed	3 / 41 (7.32%)	0 / 40 (0.00%)	0 / 43 (0.00%)	0 / 42 (0.00%)
occurrences all number	3	0	0	0

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/25785968

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Clinical trials

Clinical Trial Results:
A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn‟s disease (Ileo-Colitis)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: The primary efficacy endpoint was the percentage of subjects in remission, defined as CDAI < 150, at Day 15 (Week 2) (after 14 days of study drug treatment), which is maintained at Week 4.

Primary: The primary efficacy endpoint was the percentage of subjects in remission, defined as CDAI < 150, at Day 15 (Week 2) (after 14 days of study drug treatment), which is maintained at Week 4.

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at Week 2

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at Week 2

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at week 4

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at week 4

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Austria
Belgium
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Croatia
Cyprus
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Denmark
Estonia
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France
Germany
Greece
Hungary
Iceland
Ireland
Italy
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Netherlands
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United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn‟s disease (Ileo-Colitis)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: The primary efficacy endpoint was the percentage of subjects in remission, defined as CDAI < 150, at Day 15 (Week 2) (after 14 days of study drug treatment), which is maintained at Week 4.

Primary: The primary efficacy endpoint was the percentage of subjects in remission, defined as CDAI < 150, at Day 15 (Week 2) (after 14 days of study drug treatment), which is maintained at Week 4.

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at Week 2

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at Week 2

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at week 4

Secondary: Proportion of Subjects Who Attained a 100-point Clinical Response at week 4

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn‟s disease (Ileo-Colitis)