Acute Ulcerative ColitisPhase 3Precision-UCNCT01903252
TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
A Phase 3 study testing TP05 and Asacol 400 mg in people with Acute Ulcerative Colitis, run by Tillotts Pharma AG at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ulcerative Colitis
- What is being tested?
- TP05 and Asacol 400 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Nov 2016
- Phase
- Phase 3
- 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
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Ulcerative Colitis
- Being tested
- TP05, Asacol 400 mg
- Keywords
- UC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP05Drug
Also called Mesalazine 1600 mg
3.2g/day once daily for 12 weeks (blinded), 1.6g/d - 4.8g/d up to week 38 (open label)
Asacol 400 mgDrug
Also called Mesalazine (Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded), switch to 1.6g/ - 4.8g/d TP05 up to week 38 (open label)
| Study group | Role | What they receive |
|---|---|---|
| TP05 (Mesalazine) 1600mg | Experimental | week 1 - week 12 (blinded), week 13 - week 38 (OpenLabel) Receives: Drug: TP05 |
| Asacol 400 mg (Tillotts Pharma) | Active comparator | week 1 - week 12 (blinded), switch to TP05 for weeks 13-38 (open label) Receives: Drug: Asacol 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Clinical and Endoscopic Remission
Mayo Score of <= 2 points with no individual sub-score > 1
Measured: Week 8
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.
Measured: Week 16
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)
Measured: Week 38
Secondary outcomes (30)
Period 1: Endoscopic Remission
Endoscopic remission was defined as a Mayo endoscopy subscore of 0
Measured: Week 8
Period 1: Endoscopic Response
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Measured: Week 8
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)
Measured: Week 8
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
Measured: Week 8
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.
Measured: Week 8
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)
Measured: Week 12
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.
Measured: Week 12
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
Measured: Week 12
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)
Measured: Week 8 and week 12
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.
Measured: Week 8 and Week 12
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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)
Measured: Week 16
Period 2: Rectal Bleeding Sub-score of 0
Percentage of patients achieving the endpoint rectal bleeding sub-score of 0
Measured: Week 16
Period 2: Stool Frequency 0
Percentage of patients achieving the endpoint stool frequency sub-score of 0
Measured: Week 16
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.
Measured: Week 16
Period 2: UC-Related Complications
Percentage of Patients Experiencing Complications related to UC
Measured: Week 16
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.
Measured: Week 38
Period 3: Clinical and Endoscopic Remission
Mayo Score of <= 2 points with no individual sub-score > 1
Measured: Week 38
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.
Measured: Week 38
Period 3: Endoscopic Remission
Percentage of each dose group achieving an endoscopy sub score of 0
Measured: Week 38
Period 3: Endoscopic Response
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Measured: Week 38
Period 3: Rectal Bleeding Sub Score of 0
Percentage of each dose group achieving the endpoint rectal bleeding subscore 0
Measured: Week 38
Period 3: Stool Frequency Sub-score 0
Patients achieving a Stool Frequency sub-score of 0
Measured: Week 38
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.
Measured: Week 38
Period 3: UC-Related Complications
Percentage of Patients with Complications related to UC
Measured: Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2016
- Study completionNov 2016
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Ulcerative ColitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tillotts Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert R D'Haens, MD, PhD, Principal investigator, Alimentiv Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903252
- Sponsor's protocol ID
- TP0503
- Acronym
- Precision-UC
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2013
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33279779Ma 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.
PubMed 31546056D'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.
PubMed 28568974
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01903252
- Acronym / sponsor ID
- Precision-UC / TP0503
- Conditions
- Acute Ulcerative Colitis
- Keywords
- UC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Tillotts Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TP05 (Mesalazine) 1600mg | Experimental | Drug: TP05week 1 - week 12 (blinded), week 13 - week 38 (OpenLabel) |
| Asacol 400 mg (Tillotts Pharma) | Active comparator | Drug: Asacol 400 mgweek 1 - week 12 (blinded), switch to TP05 for weeks 13-38 (open label) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TP05Also: Mesalazine 1600 mg3.2g/day once daily for 12 weeks (blinded), 1.6g/d - 4.8g/d up to week 38 (open label) | Drug | TP05 (Mesalazine) 1600mg |
| Asacol 400 mgAlso: Mesalazine (Tillotts Pharma AG)3.2g/d twice daily for 12 weeks (blinded), switch to 1.6g/ - 4.8g/d TP05 up to week 38 (open label) | Drug | Asacol 400 mg (Tillotts Pharma) |
Primary outcome
Period 1: Clinical and Endoscopic Remission
Time frame: Week 8
Mayo Score of <= 2 points with no individual sub-score > 1
Period 2: Clinical Response, Open-Label Extended Induction
Time frame: Week 16
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
Time frame: Week 38
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
30 secondary outcomes
Period 1: Endoscopic Remission
Time frame: Week 8
Period 1: Endoscopic Response
Time frame: Week 8
Period 1: Clinical Remission
Time frame: Week 8
Period 1: Rectal Bleeding Sub-score of 0
Time frame: Week 8
Period 1: Clinical and Endoscopic Response
Time frame: Week 8
Period 1: Clinical Remission
Time frame: Week 12
Period 1: Clinical Response
Time frame: Week 12
Period 1: Rectal Bleeding Score of 0
Time frame: Week 12
Period 1: Clinical Remission at Both Week 8 and 12
Time frame: Week 8 and week 12
Period 1: Clinical Response at Both Week 8 and Week 12
Time frame: Week 8 and Week 12
Period 1: Change in Mayo Score From Baseline
Time frame: Baseline and Week 8
Period 1: Change in Partial Mayo Score From Baseline
Time frame: Baseline and Week 8
Period 1: Change in Stool Frequency Score
Time frame: Baseline and Week 8
Period 1: Change in Rectal Bleeding Score From Baseline
Time frame: Baseline and Week 8
Period 1: Change in Physician Global Assessment Score From Baseline
Time frame: Baseline and Week 8
Period 1: Change in Endoscopic Score From Baseline
Time frame: Baseline and Week 8
Period 2: Clinical Remission
Time frame: Week 16
Period 2: Rectal Bleeding Sub-score of 0
Time frame: Week 16
Period 2: Stool Frequency 0
Time frame: Week 16
Period 2: Urgency
Time frame: Week 16
Period 2: UC-Related Complications
Time frame: Week 16
Period 3: Clinical Response
Time frame: Week 38
Period 3: Clinical and Endoscopic Remission
Time frame: Week 38
Period 3: Clinical and Endoscopic Response
Time frame: Week 38
Period 3: Endoscopic Remission
Time frame: Week 38
Period 3: Endoscopic Response
Time frame: Week 38
Period 3: Rectal Bleeding Sub Score of 0
Time frame: Week 38
Period 3: Stool Frequency Sub-score 0
Time frame: Week 38
Period 3: No Urgency
Time frame: Week 38
Period 3: UC-Related Complications
Time frame: Week 38
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33279779Ma 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.
- Derived from this study: PubMed 31546056Ma 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.
- Derived from this study: PubMed 28568974D'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.
- Individual participant dataSharing planned: No
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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.
Geert R D'Haens, MD, PhD principal investigator
Alimentiv Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TP05 and Asacol 400 mg in people with Acute Ulcerative Colitis, run by Tillotts Pharma AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Aug 2018). 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?
Period 1: Clinical and Endoscopic Remission (time frame: Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01903252, which also lists 3 linked publications.
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 8 Aug 2018.