Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.

A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000366-11-SE

Enrollment

800

Registered

2013-05-13

Start date

2013-06-28

Completion date

Unknown

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Code: TP05 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Current Sponsor code: TP05 Concentration unit: g gram(s) Concentration type: up to C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Induction: (1) Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomisation, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). (2) Documented diagnosis of UC: the diagnosis of UC is based on the site investigator’s assessment and should be available at randomisation. (3) Active UC defined by: a. Mayo score of = 5 b. Sigmoidoscopy component score = 2 confirmed by central review and c. Rectal bleeding component score = 1 (4) Ability of the subject to participate fully in all aspects of this clinical trial. (5) Written informed consent must be obtained and documented. OLE: (1) Attendance at the Week 8 visit and completion of disease activity assessments prior to enrolment in OLE at Week 12 (responders or remitters) or Week 8 (non-responders). (2) At least 75% compliance with study medication in the induction phase. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 752 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

Exclusion criteria: Induction: (1) Severe UC defined by the following criteria: = 6 bloody stools daily with one or more of the following: a. oral temperature > 37.8°C or > 100.0°F b. pulse > 90 beats/min c. haemoglobin 2.5 g/day within 4 weeks prior to randomisation. Pre-study mesalamine therapy at a dose of 2.5g/day or less must be stopped at Visit 2. (4) Treatment with rectal mesalamine within 2 weeks prior to randomisation (5) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation. (6) Treatment with immunosuppressants within 6 weeks prior to randomisation. (7) Treatment with infliximab or other biologics within 3 months prior to randomisation. (8) Treatment with antibiotics within 7 days prior to randomisation. (9) Treatment with anti-diarrhoeals within 7 days prior to randomisation. (10) Treatment with nicotine patch within 7 days prior to randomisation. (11) Received any investigational drug within 30 days prior to randomisation. (12) History of colectomy or partial colectomy. (13) History of definite dysplasia in colonic biopsies. (14) Crohn’s disease. (15) Immediate or significant risk of toxic megacolon. (16) Known bleeding disorders. (17) Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA. (18) Serum creatinine > 1.5 times the upper limit of the normal range. (19) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range. (20) Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject’s ability to fully participate in the study. (21) History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures. (22) Stools positive for Clostridium difficile toxin. (23) Pregnant or lactating women. (24) Prior enrolment in the study. OLE: (1) Withdrawal from the induction phase prior to the Week 8 visit.

Design outcomes

Primary

Measure	Time frame
Main Objective: Induction: The primary objective of the Induction phase is to determine if 8 weeks of treatment with 3.2 g/day of TP05 is not inferior to 3.2 g/day of Asacol™ in inducing clinical and endoscopic remission (a score = 2 points on the Mayo scoring scale with no individual sub-score > 1 point) in subjects with active mild to moderate Ulcerative Colitis (UC). Open Label Extension (OLE): The primary objective of the OLE is to assess the safety and tolerability of TP05 over a 26-week period in subjects achieving endoscopic and clinical remission or exhibiting a response during the initial phase of TP0503. Maintenance of clinical remission by TP05 will also be assessed by determining the proportion of patients in clinical remission at the final visit.;Secondary Objective: Induction: Proportion of subjects achieving: - endoscopic remission at Week 8 - clinical remission at Week 8 or 12 - a rectal bleeding sub-score of 0 at Week 8 or 12 - clinical remission at both Week 8 and 12 - a clinical and endoscopic response at Week 8 - a clinical response at Week 12 - a clinical response at Week 8 and 12 Also: - change in Mayo scores and PMCS at Week 8 and 12 - change in rectal bleeding and stool frequency at Week 8 and 12 OLE: To assess whether a dose escalation to 4.8 g/day of TP05 is effective in inducing remission in subjects who fail to respond to either Asacol™ or TP05 during induction. Quality of life will also be assessed using the SF-36, EQ-5D, WPAI-UC, subject and physician global ratings. Exploratory analyses of potential associations between patient characteristics and clinical remission as well as AEs or SAEs will be conducted as well as the relationship between faecal calprotectin levels and UC disease severity.;Primary end point(s): The primary efficacy endpoint is the proportion of subjects in clinical and endoscopic remission after 8 weeks of treatment, defined as achieving a Mayo score of = 2 points, with no individual sub-score > 1 point at the Wee	—

Measure

Time frame

Main Objective: Induction: The primary objective of the Induction phase is to determine if 8 weeks of treatment with 3.2 g/day of TP05 is not inferior to 3.2 g/day of Asacol™ in inducing clinical and endoscopic remission (a score = 2 points on the Mayo scoring scale with no individual sub-score > 1 point) in subjects with active mild to moderate Ulcerative Colitis (UC). Open Label Extension (OLE): The primary objective of the OLE is to assess the safety and tolerability of TP05 over a 26-week period in subjects achieving endoscopic and clinical remission or exhibiting a response during the initial phase of TP0503. Maintenance of clinical remission by TP05 will also be assessed by determining the proportion of patients in clinical remission at the final visit.;Secondary Objective: Induction: Proportion of subjects achieving: - endoscopic remission at Week 8 - clinical remission at Week 8 or 12 - a rectal bleeding sub-score of 0 at Week 8 or 12 - clinical remission at both Week 8 and 12 - a clinical and endoscopic response at Week 8 - a clinical response at Week 12 - a clinical response at Week 8 and 12 Also: - change in Mayo scores and PMCS at Week 8 and 12 - change in rectal bleeding and stool frequency at Week 8 and 12 OLE: To assess whether a dose escalation to 4.8 g/day of TP05 is effective in inducing remission in subjects who fail to respond to either Asacol™ or TP05 during induction. Quality of life will also be assessed using the SF-36, EQ-5D, WPAI-UC, subject and physician global ratings. Exploratory analyses of potential associations between patient characteristics and clinical remission as well as AEs or SAEs will be conducted as well as the relationship between faecal calprotectin levels and UC disease severity.;Primary end point(s): The primary efficacy endpoint is the proportion of subjects in clinical and endoscopic remission after 8 weeks of treatment, defined as achieving a Mayo score of = 2 points, with no individual sub-score > 1 point at the Wee

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints based on changes in the Mayo score and the PMCS include: - the proportion of subjects achieving endoscopic remission (endoscopic sub-score of 0) at Week 8 - the proportion of subjects achieving clinical remission at Week 8 - the proportion of subjects achieving a rectal bleeding sub-score of 0 at Week 8 - the proportion of subjects achieving clinical remission at Week 12 - the proportion of patients achieving a rectal bleeding sub-score of 0 at Week 12 - the proportion of subjects achieving clinical remission at both Week 8 and Week 12 - the proportion of subjects achieving a clinical and endoscopic response at Week 8 - the proportion of subjects achieving a clinical response at Week 12 - the proportion of subjects achieving a clinical response at both Week 8 and Week 12 - the changes in Mayo scores and PMCS at Week 8 and Week 12, respectively - the changes in rectal bleeding and stool frequency at both Week 8 and Week 12;Timepoint(s) of evaluation of this end point: Week 8 and 12.	—

Measure

Time frame

Secondary end point(s): Secondary efficacy endpoints based on changes in the Mayo score and the PMCS include: - the proportion of subjects achieving endoscopic remission (endoscopic sub-score of 0) at Week 8 - the proportion of subjects achieving clinical remission at Week 8 - the proportion of subjects achieving a rectal bleeding sub-score of 0 at Week 8 - the proportion of subjects achieving clinical remission at Week 12 - the proportion of patients achieving a rectal bleeding sub-score of 0 at Week 12 - the proportion of subjects achieving clinical remission at both Week 8 and Week 12 - the proportion of subjects achieving a clinical and endoscopic response at Week 8 - the proportion of subjects achieving a clinical response at Week 12 - the proportion of subjects achieving a clinical response at both Week 8 and Week 12 - the changes in Mayo scores and PMCS at Week 8 and Week 12, respectively - the changes in rectal bleeding and stool frequency at both Week 8 and Week 12;Timepoint(s) of evaluation of this end point: Week 8 and 12.

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Countries

Belarus, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Latvia, Lithuania, Norway, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Ukraine, United Kingdom

Contacts

Public ContactSenior Clinical Project Manager

Robarts Clinical Trials Inc.

Tanja.vanviegen@robartsinc.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026