Back to resultsTP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) (Precision-UC)
Primary Purpose
Acute Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
TP05
Asacol 400 mg
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ulcerative Colitis focused on measuring UC
Eligibility Criteria
Induction phase - Main criteria for inclusion include:
- 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]).
- Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.
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
- Ability of the subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Induction Phase - Main criteria for exclusion include:
Subjects who exhibit any of the following conditions are to be excluded from the study:
(1) Severe UC defined by the following criteria: 6 bloody stools daily with one or more of the following:
- a. oral temperature > 37.8 degrees C or > 100.0 degrees F
- b. pulse > 90 beats/min
c. haemoglobin < 10 g/dL (2) Treatment with oral mesalamine at a dose of > 2.4 g/day within 4 weeks prior to randomisation.
(3) Treatment with topical therapy (mesalamine or corticosteroids) within 2 weeks prior to randomisation (4) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation.
(5) Treatment with immunosuppressants within 6 weeks prior to randomisation. (6) Treatment with infliximab or other biologics within 3 months prior to randomisation.
(7) Treatment with antibiotics within 7 days prior to randomisation. (8) Treatment with probiotics within 7 days prior to randomisation. (9) Treatment with anti-diarrhoeal treatment 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 mesalazine. (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 - Main criteria for inclusion include:
- 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).
- At least 75% compliance with study medication in the induction phase.
OLE - Main criteria for exclusion include:
(1) Withdrawal from the induction phase prior to the Week 8 visit.
Sites / Locations
- Tillotts Pharma AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TP05 (Mesalazine) 1600mg
Asacol 400 mg (Tillotts Pharma)
Arm Description
week 1 - week 12 (blinded), week 13 - week 38 (OpenLabel)
week 1 - week 12 (blinded), switch to TP05 for weeks 13-38 (open label)
Outcomes
Primary Outcome Measures
Period 1: Clinical and Endoscopic Remission
Mayo Score of <= 2 points with no individual sub-score > 1
Period 2: Clinical Response, Open-Label Extended Induction
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Period 3: Clinical Remission
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Secondary Outcome Measures
Period 1: Endoscopic Remission
Endoscopic remission was defined as a Mayo endoscopy subscore of 0
Period 1: Endoscopic Response
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Period 1: Clinical Remission
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Period 1: Rectal Bleeding Sub-score of 0
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Period 1: Clinical and Endoscopic Response
Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.
Period 1: Clinical Remission
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Period 1: Clinical Response
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Period 1: Rectal Bleeding Score of 0
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Period 1: Clinical Remission at Both Week 8 and 12
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Period 1: Clinical Response at Both Week 8 and Week 12
A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Period 1: Change in Mayo Score From Baseline
Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups.
The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success.
Period 1: Change in Partial Mayo Score From Baseline
Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician's global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success.
Period 1: Change in Stool Frequency Score
Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success.
Period 1: Change in Rectal Bleeding Score From Baseline
Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success.
Period 1: Change in Physician Global Assessment Score From Baseline
Between-Group Difference of Physician Global Assessment Score, Change from Baseline.
The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Period 1: Change in Endoscopic Score From Baseline
Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Period 2: Clinical Remission
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Period 2: Rectal Bleeding Sub-score of 0
Percentage of patients achieving the endpoint rectal bleeding sub-score of 0
Period 2: Stool Frequency 0
Percentage of patients achieving the endpoint stool frequency sub-score of 0
Period 2: Urgency
Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits.
Period 2: UC-Related Complications
Percentage of Patients Experiencing Complications related to UC
Period 3: Clinical Response
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Period 3: Clinical and Endoscopic Remission
Mayo Score of <= 2 points with no individual sub-score > 1
Period 3: Clinical and Endoscopic Response
Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and > 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1.
Period 3: Endoscopic Remission
Percentage of each dose group achieving an endoscopy sub score of 0
Period 3: Endoscopic Response
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Period 3: Rectal Bleeding Sub Score of 0
Percentage of each dose group achieving the endpoint rectal bleeding subscore 0
Period 3: Stool Frequency Sub-score 0
Patients achieving a Stool Frequency sub-score of 0
Period 3: No Urgency
No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days.
Period 3: UC-Related Complications
Percentage of Patients with Complications related to UC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01903252
Brief Title
TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
Acronym
Precision-UC
Official Title
A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tillotts Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study was to compare the medication TP05 to the medication Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and tolerability of TP05. This study investigated whether TP05 is as good as (non-inferior to) Asacol™(1).
(1)The trademark Asacol™ is registered in over 55 countries as Asacol™ and as Octasa™, Fivasa™, Lixacol™, Asacolon™ in the United Kingdom, France, Spain and Ireland, respectively. The rights to Asacol, including the rights to the trademark, are owned by Tillotts Pharma AG in various countries except for the following: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands and Luxembourg.
Detailed Description
This is a Phase 3, randomised, double-blind, active-controlled, multi-centre, non-inferiority trial evaluating the safety and efficacy of 3.2 g of TP05/day compared to 3.2 g/day of Asacol™ with an open label extension to assess the long-term safety and tolerability of TP05 administered over a 26 week period. A total of 817 subjects with mildly to moderately active UC were evaluated. Eligible subjects were randomly assigned in a 1:1 ratio to receive 3.2 g/day of TP05 (administered once daily(OD)) or 3.2 g/day of Asacol™. The primary efficacy outcome was assessed at Week 8. All subjects who respond to TP05/Asacol™ (response or remission) continued receiving blinded study treatment for up to 12 weeks. After that, subjects could enroll in an Open Label Extension (OLE) for 26 weeks duration to receive TP05. Subjects failing to respond to study drug at the Week 8 visit could enroll in the OLE at week 8 and received 4.8 g/day of TP05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ulcerative Colitis
Keywords
UC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
817 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TP05 (Mesalazine) 1600mg
Arm Type
Experimental
Arm Description
week 1 - week 12 (blinded), week 13 - week 38 (OpenLabel)
Arm Title
Asacol 400 mg (Tillotts Pharma)
Arm Type
Active Comparator
Arm Description
week 1 - week 12 (blinded), switch to TP05 for weeks 13-38 (open label)
Intervention Type
Drug
Intervention Name(s)
TP05
Other Intervention Name(s)
Mesalazine 1600 mg
Intervention Description
3.2g/day once daily for 12 weeks (blinded), 1.6g/d - 4.8g/d up to week 38 (open label)
Intervention Type
Drug
Intervention Name(s)
Asacol 400 mg
Other Intervention Name(s)
Mesalazine (Tillotts Pharma AG)
Intervention Description
3.2g/d twice daily for 12 weeks (blinded), switch to 1.6g/ - 4.8g/d TP05 up to week 38 (open label)
Primary Outcome Measure Information:
Title
Period 1: Clinical and Endoscopic Remission
Description
Mayo Score of <= 2 points with no individual sub-score > 1
Time Frame
Week 8
Title
Period 2: Clinical Response, Open-Label Extended Induction
Description
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame
Week 16
Title
Period 3: Clinical Remission
Description
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame
Week 38
Secondary Outcome Measure Information:
Title
Period 1: Endoscopic Remission
Description
Endoscopic remission was defined as a Mayo endoscopy subscore of 0
Time Frame
Week 8
Title
Period 1: Endoscopic Response
Description
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Time Frame
Week 8
Title
Period 1: Clinical Remission
Description
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame
Week 8
Title
Period 1: Rectal Bleeding Sub-score of 0
Description
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Time Frame
Week 8
Title
Period 1: Clinical and Endoscopic Response
Description
Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.
Time Frame
Week 8
Title
Period 1: Clinical Remission
Description
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame
Week 12
Title
Period 1: Clinical Response
Description
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame
Week 12
Title
Period 1: Rectal Bleeding Score of 0
Description
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Time Frame
Week 12
Title
Period 1: Clinical Remission at Both Week 8 and 12
Description
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame
Week 8 and week 12
Title
Period 1: Clinical Response at Both Week 8 and Week 12
Description
A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame
Week 8 and Week 12
Title
Period 1: Change in Mayo Score From Baseline
Description
Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups.
The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success.
Time Frame
Baseline and Week 8
Title
Period 1: Change in Partial Mayo Score From Baseline
Description
Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician's global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success.
Time Frame
Baseline and Week 8
Title
Period 1: Change in Stool Frequency Score
Description
Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success.
Time Frame
Baseline and Week 8
Title
Period 1: Change in Rectal Bleeding Score From Baseline
Description
Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success.
Time Frame
Baseline and Week 8
Title
Period 1: Change in Physician Global Assessment Score From Baseline
Description
Between-Group Difference of Physician Global Assessment Score, Change from Baseline.
The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Time Frame
Baseline and Week 8
Title
Period 1: Change in Endoscopic Score From Baseline
Description
Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Time Frame
Baseline and Week 8
Title
Period 2: Clinical Remission
Description
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame
Week 16
Title
Period 2: Rectal Bleeding Sub-score of 0
Description
Percentage of patients achieving the endpoint rectal bleeding sub-score of 0
Time Frame
Week 16
Title
Period 2: Stool Frequency 0
Description
Percentage of patients achieving the endpoint stool frequency sub-score of 0
Time Frame
Week 16
Title
Period 2: Urgency
Description
Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits.
Time Frame
Week 16
Title
Period 2: UC-Related Complications
Description
Percentage of Patients Experiencing Complications related to UC
Time Frame
Week 16
Title
Period 3: Clinical Response
Description
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame
Week 38
Title
Period 3: Clinical and Endoscopic Remission
Description
Mayo Score of <= 2 points with no individual sub-score > 1
Time Frame
Week 38
Title
Period 3: Clinical and Endoscopic Response
Description
Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and > 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1.
Time Frame
Week 38
Title
Period 3: Endoscopic Remission
Description
Percentage of each dose group achieving an endoscopy sub score of 0
Time Frame
Week 38
Title
Period 3: Endoscopic Response
Description
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Time Frame
Week 38
Title
Period 3: Rectal Bleeding Sub Score of 0
Description
Percentage of each dose group achieving the endpoint rectal bleeding subscore 0
Time Frame
Week 38
Title
Period 3: Stool Frequency Sub-score 0
Description
Patients achieving a Stool Frequency sub-score of 0
Time Frame
Week 38
Title
Period 3: No Urgency
Description
No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days.
Time Frame
Week 38
Title
Period 3: UC-Related Complications
Description
Percentage of Patients with Complications related to UC
Time Frame
Week 38
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Induction phase - Main criteria for inclusion include:
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]).
Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.
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
Ability of the subject to participate fully in all aspects of this clinical trial.
Written informed consent must be obtained and documented.
Induction Phase - Main criteria for exclusion include:
Subjects who exhibit any of the following conditions are to be excluded from the study:
(1) Severe UC defined by the following criteria: 6 bloody stools daily with one or more of the following:
a. oral temperature > 37.8 degrees C or > 100.0 degrees F
b. pulse > 90 beats/min
c. haemoglobin < 10 g/dL (2) Treatment with oral mesalamine at a dose of > 2.4 g/day within 4 weeks prior to randomisation.
(3) Treatment with topical therapy (mesalamine or corticosteroids) within 2 weeks prior to randomisation (4) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation.
(5) Treatment with immunosuppressants within 6 weeks prior to randomisation. (6) Treatment with infliximab or other biologics within 3 months prior to randomisation.
(7) Treatment with antibiotics within 7 days prior to randomisation. (8) Treatment with probiotics within 7 days prior to randomisation. (9) Treatment with anti-diarrhoeal treatment 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 mesalazine. (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 - Main criteria for inclusion include:
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).
At least 75% compliance with study medication in the induction phase.
OLE - Main criteria for exclusion include:
(1) Withdrawal from the induction phase prior to the Week 8 visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert R D'Haens, MD, PhD
Organizational Affiliation
Alimentiv Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tillotts Pharma AG
City
Rheinfelden
State/Province
Baslerstrasse 15
ZIP/Postal Code
4310
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33279779
Citation
Ma C, Jeyarajah J, Guizzetti L, Parker CE, Singh S, Dulai PS, D'Haens GR, Sandborn WJ, Feagan BG, Jairath V. Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Feb;20(2):447-454.e1. doi: 10.1016/j.cgh.2020.11.040. Epub 2020 Dec 3.
Results Reference
derived
PubMed Identifier
31546056
Citation
Ma C, Sandborn WJ, D'Haens GR, Zou G, Stitt LW, Singh S, Ananthakrishnan AN, Dulai PS, Khanna R, Jairath V, Feagan BG. Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1760-1768.e1. doi: 10.1016/j.cgh.2019.09.021. Epub 2019 Sep 20.
Results Reference
derived
PubMed Identifier
28568974
Citation
D'Haens GR, Sandborn WJ, Zou G, Stitt LW, Rutgeerts PJ, Gilgen D, Jairath V, Hindryckx P, Shackelton LM, Vandervoort MK, Parker CE, Muller C, Pai RK, Levchenko O, Marakhouski Y, Horynski M, Mikhailova E, Kharchenko N, Pimanov S, Feagan BG. Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther. 2017 Aug;46(3):292-302. doi: 10.1111/apt.14164. Epub 2017 Jun 1.
Results Reference
derived
Learn more about this trial
TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
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