Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000189-19 | EudraCT Number |
Not provided
Not provided
As no safety warnings were detected, Interim analysis from the first 40 patients recommends to stop the trial for futility
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Objectives:
The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d. for 8 consecutive weeks, to induce complete healing of mucosal ulcerations of ileum and/or colon, assessed by endoscopy, in patients with endoscopic and clinical evidence of active moderate-to-severe Crohn's disease not controlled by conventional therapies.
The secondary objectives of the study were:
The study was conducted according to a randomized, double-blind placebo-controlled, parallel group design in up to 25 clinical sites in Europe.
Eligible patients were randomly assigned to two parallel treatment groups (1:1 randomization ratio) receiving either ITF2357, as hard gelatine capsule for oral administration, at the dose of 50 mg b.i.d. (total daily dose of 100 mg), or matching placebo capsules.
Treatment was administered on an outpatient basis for 8 consecutive weeks, followed by a 4-week follow-up.
During screening, in the 8-week treatment period and in the 4-week follow-up period, patients attended scheduled visits, with physical and laboratory assessments, in order to monitor disease evolution and safety and tolerability of ITF2357.
The study was planned to be conducted in up to 80 patients of both genders, with established diagnosis of CD, who presented with ulcerations greater than aphthous ulcers in at least one of the five bowel segments investigated endoscopically, from the ileum to the rectum, with endoscopic and clinical evidence of moderate-to-severe active disease, not controlled by on-going treatment with conventional therapies such as 5-aminosalicylates, steroids or immunosuppressants.
The present study has been designed in order to assessed wether short-term (8 weeks) treatment with oral ITF2357 can induce disease improvement in a substantial proportion of patients.
Its aim to evaluate whether a short term treatment with ITF2357 for 8 weeks, at the selected dose of 50 mg b.i.d., is able to induce healing of mucosal lesions, evaluated endoscopically, in patients with endoscopic and clinical evidence of moderate-to-severe active Crohn's disease, not controlled by ongoing treatment with conventional therapies such as 5-aminosalicylates, steroids or immunosuppressants, was not addressed and the study was prematurely interrupted according to IDSMC (Independent Data and Safety Monitoring Committee) decision, based on the results of the interim analysis, which did not demonstrate any benefit of ITF2357 over placebo in the primary variable rate of patients achieving complete healing at week 8.
There was also no evidence of benefits in patients treated with ITF2357 compared to placebo in the secondary efficacy endpoints (full remission rate, remission rate, CDEIS endoscopic response, changes from baseline of CDEIS score and SES-CD score, changes from baseline of CDAI score, CDAI remission rate, and CDAI response rate).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral matching placebo capsules, administered bid. |
|
| ITF2357 | Experimental | Oral ITF2357 50 mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITF2357 | Drug | ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Complete Healing of Mucosal Ulcerations of Ileum and/or Colon | The outcome is assessed by endoscopy, in patients with endoscopic and clinical evidence of active moderate-to-severe Crohn's disease not controlled by conventional therapies. The outcome measure defines the rate of patients achieving complete healing in ITT population, i.e disappearance of mucosal ulceration, obtained with ITF2357 treatment. | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Full Endoscopic Remission ( Based on CDEIS Score) | CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon; A patient was defined 'fully endoscopic remissed' whether the CDEIS score at week 8 was equal or lower than three points CDEIS score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon. The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. Score Scale: < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. The higher the score, the worse is patient's situation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Rutgeerts, MD | University Hospital Gasthuisberg, Leuven, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint Lucas Gastro-enterologie | Assebroek | 8310 | Belgium | |||
| Imelda Hospital Gastro-enterology dept. |
Not provided
Fifty-one (51) subjects were enrolled in the study, as planned, and 37 of them completed the study as per protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oral matching placebo capsules, administered bid. Placebo: Placebo will be supplied as matching capsules for oral administration with the same outer appearance of the study drug and with the same dosing scheme (one capsule in the morning and one in the evening) |
| FG001 | ITF2357 | Oral ITF2357 50 mg bid ITF2357: ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT: All randomized patients who received at least one treatment with study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Oral matching placebo capsules, administered bid. Placebo: Placebo will be supplied as matching capsules for oral administration with the same outer appearance of the study drug and with the same dosing scheme (one capsule in the morning and one in the evening) |
| BG001 | ITF2357 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Complete Healing of Mucosal Ulcerations of Ileum and/or Colon | The outcome is assessed by endoscopy, in patients with endoscopic and clinical evidence of active moderate-to-severe Crohn's disease not controlled by conventional therapies. The outcome measure defines the rate of patients achieving complete healing in ITT population, i.e disappearance of mucosal ulceration, obtained with ITF2357 treatment. | ITT: population included all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | At week 8 |
|
Adverse event data were collected from Week 0 up to week 8 and during follow up period (which lasts for one month)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Oral matching placebo capsules, administered bid. Placebo: Placebo will be supplied as matching capsules for oral administration with the same outer appearance of the study drug and with the same dosing scheme (one capsule in the morning and one in the evening) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Bradycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiziano Oldoni, MD | Italfarmaco SpA | +39 0264432540 | t.oldoni@italfarmaco.com |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502418 | givinostat hydrochloride |
| C575255 | givinostat |
Not provided
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|
| Placebo | Other | Placebo was supplied as matching capsules for oral administration with the same outer appearance of the study drug and with the same dosing scheme (one capsule in the morning and one in the evening) |
|
| At Week 8 |
| Number of Patients Achieving Endoscopic Remission (Based on CDEIS Score) | CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon; A patient was defined 'endoscopic remissed' whether the CDEIS score at week 8 was equal or lower than six points. CDEIS score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon ). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The higher the score, the worse is patient's situation. Score Scale: < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. A patient was defined 'endoscopic remissed' whether the CDEIS score at week 8 was equal or lower than six points. | At week 8 |
| Number of Patients Achieving Endoscopic Response (Based on CDEIS Score) | CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon; A patient was considered in 'endoscopic response' whether the change in CDEIS score at week 8 versus baseline was equal or greater than 4.5 points. CDEIS score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon ). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The higher the score, the worse is patient's situation Score Scale: < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. A patient was considered in 'endoscopic response' whether the change in CDEIS score at week 8 versus baseline was equal or greater than 4.5 points. | At week 8 |
| The Mean Changes of Crohn's Disease Endoscopic Index of Severity (CDEIS) From Baseline to Week 8 | CDEIS is an index to determ the endoscopic severity of Crohn's disease. Its score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). These 4 parameters are: Deep ulcerations (12 if present, 0 if absent = total 1); Superficial ulcerations (6 if present, 0 if absent = total 2); Surface involved by disease (mm/10 on VAS = = total 3); Surface involved by ulcerations (mm/10 on VAS = total 4). Sum of Totals 1+2+3+4 =Total A Number of segments visualized in part or entirely (from 1 to 5)= n Total A/n =Total B if ulcerated stenosis in any segment, add 3 =Total C If non-ulcerated stenosis in any segment, add 3= Total D Total B+C+D=CDEIS grand score (min=0; max=NA) Decoding score < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. The higher the score, the worse is patient's status. | From Baseline to week 8 |
| The Mean Changes of Simple Endoscopic Score for Crohn Disease (SES-CD) From Baseline to Week 8 | SES-CD is another index to determ the endoscopic severity of Crohn's disease. Its score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). These 4 parameters are: ulcers? 0: no; 1: aphthous (0.1-0.5 cm); 2: large (0.5-2 cm); 3: very large (>2 cm); Surface involved by inflammation 0: 0% 1: <50% 2: 50-75% 3: >75% Surface involved by ulcerations 0: 0%
0: No
Decoding score 0 - 2 remission 3 - 6 mild endoscopic activity 7 - 15 moderate endoscopic activity > 15 severe endoscopic activity | From Baseline to week 8 |
| The Mean Changes of CDAI Score From Baseline to Week 4-8-follow up | CDAI (Crohn's Disease Activity Index): frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. The higher the score, the worse is patient's situation A patient is defined 'remissed' whether the CDAI score is lower than 150 points. A patient is defined 'responder' whether the change in CDAI score versus baseline is greater to 100 points | Weeks 4 and 8, and follow-up at 1 month |
| Number of Patients Achieving Remission (Based on CDAI Score) | "Remission" is defined as the disappearance of signs and symptoms of the disease. CDAI (Crohn's Disease Activity Index): frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. The higher the score, the worse is patient's situation A patient is defined 'remissed' whether the CDAI score is lower than 150 points. A patient is defined 'responder' whether the change in CDAI score versus baseline is greater to 100 points | Weeks 4 and 8, and follow-up at 1 month |
| Number of Patients Achieving Response (Based on CDAI Score) | "Response" is defined as the reaction to a stimulus or to a treatment, especially in a favorable way. CDAI (Crohn's Disease Activity Index): frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. The higher the score, the worse is patient's situation. A patient is defined 'remissed' whether the CDAI score is lower than 150 points. A patient is defined 'responder' whether the change in CDAI score versus baseline is greater to 100 points | Weeks 4 and 8, and follow-up at 1 month |
| Number of Patients With at Least One Related Adverse Event to Study Treatment | Treatment-related adverse events are adverse events (AE) which occurs during an interventional study and which are surely related to study treatment dosing. | At Pre-Treatment period (Week 0); At treatment period (Week 1, Week 2, Week 4, week 6, Week 8); At Follow-up period (1month) |
| Plasma Levels of ITF2357 Before Morning Dose of ITF2357 | Individual plasma levels of ITF2357 (before morning dose) after repeated oral administration of ITF2357 (50mg b.i.d.) in patients with Crohn's disease were assessed. | Pre-dose, week 2, week 4, week 6 |
| Plasma Levels of Metabolite ITF2374 Before Morning Dose of ITF2357. | Individual plasma levels of metabolite ITF2374 (before morning dose) after repeated oral administration of ITF2357 (50mg b.i.d.) in patients with Crohn's disease were assessed. | Pre-dose, week 2, week 4, week 6 |
| Plasma Levels of Metabolite ITF2375 Before Morning Dose of ITF2357. | Individual plasma levels of Metabolite ITF2375 (before morning dose) after repeated oral administration of ITF2357 (50mg b.i.d.) in patients with Crohn's disease were assessed. | Pre dose, week 2, week 4, week 6. |
| Bonheiden |
| 2820 |
| Belgium |
| CHU Saint-Pierre Médecine Interne | Brussels | 1000 | Belgium |
| UZ Gent Gastro-enterologie 1K12IE | Ghent | 9000 | Belgium |
| AZ Groeninge (St-Niklaas) Gastro-enterologie | Kortrijk | 8500 | Belgium |
| University Hospital Gasthuisber | Leuven | 3000 | Belgium |
| Divisione di Gatroenterologia Istituto Clinico Humanitas IRCCS in. Gastroenterology | Rozzano | 20089 | Italy |
| Vrije Universiteit (VU) Medisch Centrum Afdeling M.D.L.ziekten | Amsterdam | 1007 MB | Netherlands |
| Academisch Medisch Centrum (AMC) Afdeling M.D.L. ziekten | Amsterdam | 1100 DD | Netherlands |
| Leids Universitair Medisch Centrum (LUMC) Afdeling M.D.L. ziekten | Leiden | 2300 RC | Netherlands |
| Adverse Event |
|
| Patient's withdrawal of consent |
|
| Termination of the trial by the Sponsor |
|
| Other reasons |
|
Oral ITF2357 50 mg bid ITF2357: ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | ITF2357 | Oral ITF2357 50 mg bid ITF2357: ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening. |
|
|
| Secondary | Number of Patients Achieving Full Endoscopic Remission ( Based on CDEIS Score) | CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon; A patient was defined 'fully endoscopic remissed' whether the CDEIS score at week 8 was equal or lower than three points CDEIS score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon. The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. Score Scale: < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. The higher the score, the worse is patient's situation. | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | At Week 8 |
|
|
|
| Secondary | Number of Patients Achieving Endoscopic Remission (Based on CDEIS Score) | CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon; A patient was defined 'endoscopic remissed' whether the CDEIS score at week 8 was equal or lower than six points. CDEIS score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon ). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The higher the score, the worse is patient's situation. Score Scale: < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. A patient was defined 'endoscopic remissed' whether the CDEIS score at week 8 was equal or lower than six points. | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | At week 8 |
|
|
|
| Secondary | Number of Patients Achieving Endoscopic Response (Based on CDEIS Score) | CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon; A patient was considered in 'endoscopic response' whether the change in CDEIS score at week 8 versus baseline was equal or greater than 4.5 points. CDEIS score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon ). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The higher the score, the worse is patient's situation Score Scale: < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. A patient was considered in 'endoscopic response' whether the change in CDEIS score at week 8 versus baseline was equal or greater than 4.5 points. | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | At week 8 |
|
|
|
| Secondary | The Mean Changes of Crohn's Disease Endoscopic Index of Severity (CDEIS) From Baseline to Week 8 | CDEIS is an index to determ the endoscopic severity of Crohn's disease. Its score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). These 4 parameters are: Deep ulcerations (12 if present, 0 if absent = total 1); Superficial ulcerations (6 if present, 0 if absent = total 2); Surface involved by disease (mm/10 on VAS = = total 3); Surface involved by ulcerations (mm/10 on VAS = total 4). Sum of Totals 1+2+3+4 =Total A Number of segments visualized in part or entirely (from 1 to 5)= n Total A/n =Total B if ulcerated stenosis in any segment, add 3 =Total C If non-ulcerated stenosis in any segment, add 3= Total D Total B+C+D=CDEIS grand score (min=0; max=NA) Decoding score < 3 remission; 3 - 8 mild endoscopic activity; 9 - 12 moderate endoscopic activity; > 12 severe endoscopic activity. The higher the score, the worse is patient's status. | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to week 8 |
|
|
|
| Secondary | The Mean Changes of Simple Endoscopic Score for Crohn Disease (SES-CD) From Baseline to Week 8 | SES-CD is another index to determ the endoscopic severity of Crohn's disease. Its score considers 4 parameters, each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). These 4 parameters are: ulcers? 0: no; 1: aphthous (0.1-0.5 cm); 2: large (0.5-2 cm); 3: very large (>2 cm); Surface involved by inflammation 0: 0% 1: <50% 2: 50-75% 3: >75% Surface involved by ulcerations 0: 0%
0: No
Decoding score 0 - 2 remission 3 - 6 mild endoscopic activity 7 - 15 moderate endoscopic activity > 15 severe endoscopic activity | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to week 8 |
|
|
|
| Secondary | The Mean Changes of CDAI Score From Baseline to Week 4-8-follow up | CDAI (Crohn's Disease Activity Index): frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. The higher the score, the worse is patient's situation A patient is defined 'remissed' whether the CDAI score is lower than 150 points. A patient is defined 'responder' whether the change in CDAI score versus baseline is greater to 100 points | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Mean | Standard Deviation | score on a scale | Weeks 4 and 8, and follow-up at 1 month |
|
|
|
| Secondary | Number of Patients Achieving Remission (Based on CDAI Score) | "Remission" is defined as the disappearance of signs and symptoms of the disease. CDAI (Crohn's Disease Activity Index): frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. The higher the score, the worse is patient's situation A patient is defined 'remissed' whether the CDAI score is lower than 150 points. A patient is defined 'responder' whether the change in CDAI score versus baseline is greater to 100 points | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | Weeks 4 and 8, and follow-up at 1 month |
|
|
|
| Secondary | Number of Patients Achieving Response (Based on CDAI Score) | "Response" is defined as the reaction to a stimulus or to a treatment, especially in a favorable way. CDAI (Crohn's Disease Activity Index): frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. The higher the score, the worse is patient's situation. A patient is defined 'remissed' whether the CDAI score is lower than 150 points. A patient is defined 'responder' whether the change in CDAI score versus baseline is greater to 100 points | ITT population included all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | Weeks 4 and 8, and follow-up at 1 month |
|
|
|
| Secondary | Number of Patients With at Least One Related Adverse Event to Study Treatment | Treatment-related adverse events are adverse events (AE) which occurs during an interventional study and which are surely related to study treatment dosing. | ITT population includes all randomized patients who took at least one dose of study treatment. | Posted | Count of Participants | Participants | At Pre-Treatment period (Week 0); At treatment period (Week 1, Week 2, Week 4, week 6, Week 8); At Follow-up period (1month) |
|
|
|
| Secondary | Plasma Levels of ITF2357 Before Morning Dose of ITF2357 | Individual plasma levels of ITF2357 (before morning dose) after repeated oral administration of ITF2357 (50mg b.i.d.) in patients with Crohn's disease were assessed. | Per Protocol Population (PP) - all randomized patients who received at least one dose of study medication without major protocol deviations | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, week 2, week 4, week 6 |
|
|
|
| Secondary | Plasma Levels of Metabolite ITF2374 Before Morning Dose of ITF2357. | Individual plasma levels of metabolite ITF2374 (before morning dose) after repeated oral administration of ITF2357 (50mg b.i.d.) in patients with Crohn's disease were assessed. | Per Protocol Population (PP) - all randomized patients who received at least one dose of study medication without major protocol deviations | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, week 2, week 4, week 6 |
|
|
|
| Secondary | Plasma Levels of Metabolite ITF2375 Before Morning Dose of ITF2357. | Individual plasma levels of Metabolite ITF2375 (before morning dose) after repeated oral administration of ITF2357 (50mg b.i.d.) in patients with Crohn's disease were assessed. | Per Protocol Population (PP) - all randomized patients who received at least one dose of study medication without major protocol deviations | Posted | Mean | Standard Deviation | ng/mL | Pre dose, week 2, week 4, week 6. |
|
|
|
| 0 |
| 26 |
| 2 |
| 26 |
| 17 |
| 26 |
| EG001 | ITF2357 | Oral ITF2357 50 mg bid ITF2357: ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening. | 0 | 25 | 3 | 25 | 20 | 25 |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Perianal Erythema | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Abdominal Tenderness | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Anal Abscess | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Faeces Discoloured | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pruritus Ani | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Gastroenteritis Rotavirus | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Blood Magnesium decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| pH Urine increased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Sputum Abnormal | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Ankylosing Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Micturition Disorder | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Bacteriuria | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Systolic Hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
Not provided
Not provided
| D007410 | Intestinal Diseases |
| At follow-up 1 month |
|
| At follow-up after one month |
|
| At follow up, after one month |
|
|
| Week 4 |
|
|
| Week 6 |
|
|
| Title | Measurements |
|---|---|
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| Week 6 |
|
| Title | Measurements |
|---|---|
|
| week 6 |
|