Crohn's DiseasePhase 1/2CDNCT00792740
Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
A Phase 1/2 study testing ITF2357 in people with Crohn's Disease, run by Italfarmaco at 10 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- ITF2357
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 22 Oct 2007to 11 Mar 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 18 years
- Diagnosis of CD, re-established by endoscopy and/or X-ray and/or surgery in the last 36 months
- CD in active phase since at least 2 weeks before screening
- CDAI between 220 and 450
- CDEIS > 8
- Ulcerations greater than aphthous ulcers in at least 1 of the bowel segments from ileum to rectum
Show all 11Show fewer
- If any on-going treatment with corticosteroids (prednisone, prednisolone or budesonide), it must be at a dose equivalent to or less than 30 mg/day prednisone, or 9 mg of budesonide, and in use for at least one month and at a stable dose for at least two weeks before patient enrolment
- If any on-going treatment with immunosuppressant (azathioprine, 6-mercaptopurine, methotrexate), it must be in use for at least 3 months before patient enrolment
- If any on-going treatment with 5-aminosalicylates, it must be in place for at least 4 weeks before patient enrolment, at a dose > 2 g
- Females of childbearing potential with negative pregnancy tests
- Signed written informed consent to participate in this trial.
Who cannot join
- Treatment in the 2 months with anti-TNF-alfa antibodies and in the previous 3 months with cytokines inhibitors or experimental drugs
- Primary failure to previous treatment with anti-TNF-alfa antibodies-
- Current bowel obstruction or any condition that may predispose to its development (e.g. clinically significant unresolved intestinal stricture, adhesions or any other condition that would place the patient at risk for developing overt bowel obstruction) or intestinal perforation or significant GI hemorrhage
- Expected surgery for the duration of the study
- Any ostomy or extensive bowel resection
- Positive serological anti-HCV and anti-HIV testing and positive testing for active HBV replication, e.g. HBV-DNA or HBsAg or HBeAg (to be performed at screening)
Show all 21Show fewer
- Other on-going clinical relevant viral infections (e.g. herpes zoster, Epstein-Barr, CMV), systemic fungal infections or history of recurrent serious bacterial infections
- Signs and symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- Any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
- QTc interval > 450 msec at pre-treatment evaluation
- Serum magnesium and potassium below the LLN at pre-treatment evaluation
- Platelet counts below 200 x 10^9/L at pre-treatment evaluation
- Any previous evidence, irrespective of its severity, of renal function impairment
- Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes
- Presence of a transplanted organ
- History of cancer with less than 5 years documentation of a disease-free state
- History of tuberculosis
- Severe lactose intolerance
- Pregnant or nursing women
- Female of childbearing potential without using a safe contraceptive measure
- Participation in a clinical trial within 30 days prior to initiation of study treatment.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Belgium6 sites
AZ Sint Lucas Gastro-enterologie
Assebroek, 8310
Imelda Hospital Gastro-enterology dept.
Bonheiden, 2820
CHU Saint-Pierre Médecine Interne
Brussels, 1000
UZ Gent Gastro-enterologie 1K12IE
Ghent, 9000
AZ Groeninge (St-Niklaas) Gastro-enterologie
Kortrijk, 8500
University Hospital Gasthuisber
Leuven, 3000
Netherlands3 sites
Vrije Universiteit (VU) Medisch Centrum Afdeling M.D.L.ziekten
Amsterdam, 1007 MB
Academisch Medisch Centrum (AMC) Afdeling M.D.L. ziekten
Amsterdam, 1100 DD
Leids Universitair Medisch Centrum (LUMC) Afdeling M.D.L. ziekten
Leiden, 2300 RC
Italy1 site
Divisione di Gatroenterologia Istituto Clinico Humanitas IRCCS in. Gastroenterology
Rozzano, 20089
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
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.
Read more
The secondary objectives of the study were:
- to evaluate the effect of ITF2357 on endoscopic disease activity assessed using both the Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score of Crohn's Disease (SES-CD);
- to evaluate the effect of ITF2357 on clinical disease activity, assessed using the Crohn's Disease Activity Index (CDAI);
- to assess the safety and tolerability of ITF2357; to assess the pharmacokinetic profile of ITF2357.
Read the detailed description
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).
- Conditions
- Crohn's Disease
- Being tested
- ITF2357, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITF2357Drug
Also called Givinostat
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.
PlaceboOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral matching placebo capsules, administered bid. Receives: Other: Placebo |
| ITF2357 | Experimental | Oral ITF2357 50 mg bid Receives: Drug: ITF2357 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 8
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%
- <10%
- 10-30%
- >30% Stenosis?
0: No
- Single, can be passed
- Multiple, can be passed
- Cannot be passed The scores for each individual segment are added together as a sum score (min=0; max=60) The higher the score, the worse the outcome.
Decoding score 0 - 2 remission 3 - 6 mild endoscopic activity 7 - 15 moderate endoscopic activity > 15 severe endoscopic activity
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre dose, week 2, week 4, week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study start22 Oct 2007
- Primary completionDec 2008
- Study completion11 Mar 2009
Why it stopped: As no safety warnings were detected, Interim analysis from the first 40 patients recommends to stop the trial for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Rutgeerts, MD, Study chair, University Hospital Gasthuisberg, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792740
- Sponsor's protocol ID
- DSC/06/2357/23
- Other IDs
- 2007-000189-19
- Acronym
- CD
- Status last verified
- Jan 2022
- First submitted
- 14 Nov 2008
- Last updated
- 19 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00792740
- Acronym / sponsor ID
- CD / DSC/06/2357/23
- Conditions
- Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As no safety warnings were detected, Interim analysis from the first 40 patients recommends to stop the trial for futility
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2007 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- 11 Mar 2009 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Posted 19 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to evaluate the effect of ITF2357 on endoscopic disease activity assessed using both the Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score of Crohn's Disease (SES-CD);
- to evaluate the effect of ITF2357 on clinical disease activity, assessed using the Crohn's Disease Activity Index (CDAI);
- to assess the safety and tolerability of ITF2357; to assess the pharmacokinetic profile of ITF2357.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboOral matching placebo capsules, administered bid. |
| ITF2357 | Experimental | Drug: ITF2357Oral ITF2357 50 mg bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: > 18 years
- Diagnosis of CD, re-established by endoscopy and/or X-ray and/or surgery in the last 36 months
- CD in active phase since at least 2 weeks before screening
- CDAI between 220 and 450
- CDEIS > 8
Key exclusion criteria (21 listed)
- Treatment in the 2 months with anti-TNF-alfa antibodies and in the previous 3 months with cytokines inhibitors or experimental drugs
- Primary failure to previous treatment with anti-TNF-alfa antibodies-
- Current bowel obstruction or any condition that may predispose to its development (e.g. clinically significant unresolved intestinal stricture, adhesions or any other condition that would place the patient at risk for developing overt bowel obstruction) or intestinal perforation or significant GI hemorrhage
- Expected surgery for the duration of the study
- Any ostomy or extensive bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITF2357Also: GivinostatITF2357 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. | Drug | ITF2357 |
| PlaceboPlacebo 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) | Other | Placebo |
Primary outcome
Number of Patients Achieving Complete Healing of Mucosal Ulcerations of Ileum and/or Colon
Time frame: At week 8
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.
12 secondary outcomes
Number of Patients Achieving Full Endoscopic Remission ( Based on CDEIS Score)
Time frame: At Week 8
Number of Patients Achieving Endoscopic Remission (Based on CDEIS Score)
Time frame: At week 8
Number of Patients Achieving Endoscopic Response (Based on CDEIS Score)
Time frame: At week 8
The Mean Changes of Crohn's Disease Endoscopic Index of Severity (CDEIS) From Baseline to Week 8
Time frame: From Baseline to week 8
The Mean Changes of Simple Endoscopic Score for Crohn Disease (SES-CD) From Baseline to Week 8
Time frame: From Baseline to week 8
The Mean Changes of CDAI Score From Baseline to Week 4-8-follow up
Time frame: Weeks 4 and 8, and follow-up at 1 month
Number of Patients Achieving Remission (Based on CDAI Score)
Time frame: Weeks 4 and 8, and follow-up at 1 month
Number of Patients Achieving Response (Based on CDAI Score)
Time frame: Weeks 4 and 8, and follow-up at 1 month
Number of Patients With at Least One Related Adverse Event to Study Treatment
Time frame: 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
Time frame: Pre-dose, week 2, week 4, week 6
Plasma Levels of Metabolite ITF2374 Before Morning Dose of ITF2357.
Time frame: Pre-dose, week 2, week 4, week 6
Plasma Levels of Metabolite ITF2375 Before Morning Dose of ITF2357.
Time frame: Pre dose, week 2, week 4, week 6.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Rutgeerts, MD study chair
University Hospital Gasthuisberg, Leuven, Belgium
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ITF2357 in people with Crohn's Disease, run by Italfarmaco at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Netherlands, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Achieving Complete Healing of Mucosal Ulcerations of Ileum and/or Colon (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.