Colitis, UlcerativePhase 3NCT06176560
Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.
A Phase 3 study testing Mesalazine in people with Colitis, Ulcerative, run by Faes Farma, S.A..
Trial summary
A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Mesalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Be ≥ 18 years of age.
- Provide written informed consent.
- Be willing and able to follow all instructions, undergo all assessments, complete the electronic diary and attend all trial visits.
- Have UC symptoms with UC diagnosis established by clinical, histological and endoscopic evidence.
- Have active, mild to moderate UC at the time of screening.
- Have a recent colonoscopy documenting the degree and extent of mucosal inflammation; otherwise, a colonoscopy must be performed during the screening period.
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- Be able and willing to avoid all disallowed medications for the appropriate washout period before randomisation and during the rest trial.
- For females of childbearing potential only: willing to perform pregnancy tests, must agree to use effective methods of birth control throughout the trial until the trial ends. Effective methods of birth control include: combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (provided that partner is the sole sexual partner of the clinical trial patient and has documentation of azoospermia) or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment). The investigator is responsible for determining whether the patient has adequate birth control for trial participation.
- For males with female partners of childbearing potential: acceptance to use birth control methods (condom with or without spermicide, or effective methods of birth control of female partner) throughout the trial duration and until 2.5 months after last intake of IMP. Vasectomy or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment) are also acceptable methods. The investigator is responsible for determining whether the patient has adequate birth control for trial participation.
Who cannot join
- Have known contraindications or sensitivities to the use of the IMPs or any of its components.
- History of difficulty in swallowing.
- Be pregnant, planning a pregnancy or breastfeeding.
- Have severe UC.
- Have a history of colonic resection (excluding appendectomy).
- Present moderate to severe renal disorder.
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- Present moderate to severe hepatic disorder.
- Have a gastrointestinal disease that in the opinion of the investigator, would have interfered with the patient's participation in this study. Including but not limited to: Crohn's disease, other forms of colitis, coeliac disease, malabsorption syndromes, present or past colorectal cancer, gastric or duodenal ulcer.
- Have ulcerative proctitis (restricted to rectum).
- Suspected or documented infectious enterocolitis.
- Have previous or current treatment with thiopurines, calcineurin inhibitors, methotrexate, JAK inhibitors and/or biologics.
- Patients who previously were refractory to treatment with oral or rectal mesalazine.
- Have a history of or current diagnosis of severe or uncontrolled pulmonary disease, myocarditis or pericarditis.
- Severe or uncontrolled asthma, that in the opinion of the investigator, would compromise the patient safety.
- Have a history of or current diagnosis of haemorrhagic diathesis.
- Have an active malignancy or treatment with antineoplastic agents during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least 5 years of uneventful follow-up and no signs of recurrence may be eligible according to the investigator's decision.
- Have participated in another clinical trial in which an investigational drug (including investigational vaccines) or invasive investigational medical device has been taken within the past 90 days (or five half-lives of IMP whichever is longer) prior to Visit 1, or simultaneous participation in another clinical trial.
- Have any condition that, in the opinion of the investigator, may jeopardise the clinical trial conduct according to the protocol.
- Be an employee of the investigator or clinical trial unit, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial unit, as well as family members of the employees or the principal investigator.
- Patients unable to understand the informed consent or having a high probability of non-compliance with the trial procedures.
- Be a person committed to an institution by virtue of an order issued either by judicial or other authorities.
About this study
Official title: A Randomised, Double-blind, Double-dummy, Multicentre, Phase III, Non Inferiority Trial of an Oral Mesalazine Formulation in Patients With Active Mild to Moderate Ulcerative Colitis for the Induction of Remission.
A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.
- Conditions
- Colitis, Ulcerative
- Being tested
- Mesalazine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalazineDrug
Oral Formulation
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine Experimental | Experimental | Mesalazine oral formulation Receives: Drug: Mesalazine |
| Mesalazine Comparator | Active comparator | Mesalazine oral formulation Receives: Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the percentage of patients with clinical remission [Mayo Modified Score (MMS) ≤ 2] and Endoscopic remission [Mayo Endoscopic Score (MES) ≤ 1] after 8 weeks of treatment.
Measured: 8 weeks
Secondary outcomes (14)
To assess the percentage of patients achieving symptomatic remission using Modified Mayo Score.
Symptomatic remission defined by Modified Mayo Score (MMS)
Measured: 8 weeks
To assess the percentage of patients achieving endoscopic remission using Mayo Endoscopic Score.
Endoscopic Remission defined by Mayo Endoscopic Score (MES)
Measured: 8 weeks
To assess the percentage of patients achieving overall response using Mayo Modified Score
Reduction in Mayo Modified Score (MMS) from baseline with a decrease of rectal bleeding subscore.
Measured: 8 weeks
To evaluate changes in the symptomatic assessments using Mayo Modified Score.
Mayo modified score: stool frequency and rectal bleeding.
Measured: 8 weeks
To evaluate changes in the endoscopic score using Mayo Endoscopic Score.
Mayo Endoscopic Score
Measured: 8 weeks
To assess the histological remission using Robarts Histopathology Index
Histologic Remission defined by Robarts Histopathology Index (RHI).
Measured: 8 weeks
To assess the percentage of patients achieving overall remission
All modified Mayo subscores = 0
Measured: 8 weeks
To assess patients' quality of life
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: 8 weeks
To evaluate change in faecal calprotectin.
Stool sample for faecal calprotectin analysis
Measured: 8 weeks
To evaluate the safety and tolerability by incidence of AEs.
Measured: 8 weeks
To evaluate the safety and tolerability by clinically significant laboratory results.
Number of patients with clinically significant results at Week 8 in haematological, biochemistry and urinalysis parameters.
Measured: 8 weeks
To evaluate the safety and tolerability by assessing clinically significant vital signs results.
Number of patients with clinically significant changes in vital signs parameters (blood pressure, heart rate and body temperature) from baseline to Week 8.
Measured: 8 weeks
To evaluate the safety and tolerability by clinically significant physical examination findings.
Number of patients with clinically significant findings in physical examination (heart, lungs, abdomen) from baseline to Week 8.
Measured: 8 weeks
To evaluate the safety and tolerability considering the percentage of patients withdrawn from the trial due to safety concerns.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startMar 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176560
- Sponsor's protocol ID
- CGRA-0121/ES
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double-dummy, Multicentre, Phase III, Non Inferiority Trial of an Oral Mesalazine Formulation in Patients With Active Mild to Moderate Ulcerative Colitis for the Induction of Remission.
- ClinicalTrials.gov ID
- NCT06176560
- Acronym / sponsor ID
- CGRA-0121/ES
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalazine Experimental | Experimental | Drug: MesalazineMesalazine oral formulation |
| Mesalazine Comparator | Active comparator | Drug: MesalazineMesalazine oral formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be ≥ 18 years of age.
- Provide written informed consent.
- Be willing and able to follow all instructions, undergo all assessments, complete the electronic diary and attend all trial visits.
- Have UC symptoms with UC diagnosis established by clinical, histological and endoscopic evidence.
- Have active, mild to moderate UC at the time of screening.
Key exclusion criteria (21 listed)
- Have known contraindications or sensitivities to the use of the IMPs or any of its components.
- History of difficulty in swallowing.
- Be pregnant, planning a pregnancy or breastfeeding.
- Have severe UC.
- Have a history of colonic resection (excluding appendectomy).
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 |
|---|---|---|
| MesalazineOral Formulation | Drug | Mesalazine Comparator, Mesalazine Experimental |
Primary outcome
To assess the percentage of patients with clinical remission [Mayo Modified Score (MMS) ≤ 2] and Endoscopic remission [Mayo Endoscopic Score (MES) ≤ 1] after 8 weeks of treatment.
Time frame: 8 weeks
14 secondary outcomes
To assess the percentage of patients achieving symptomatic remission using Modified Mayo Score.
Time frame: 8 weeks
To assess the percentage of patients achieving endoscopic remission using Mayo Endoscopic Score.
Time frame: 8 weeks
To assess the percentage of patients achieving overall response using Mayo Modified Score
Time frame: 8 weeks
To evaluate changes in the symptomatic assessments using Mayo Modified Score.
Time frame: 8 weeks
To evaluate changes in the endoscopic score using Mayo Endoscopic Score.
Time frame: 8 weeks
To assess the histological remission using Robarts Histopathology Index
Time frame: 8 weeks
To assess the percentage of patients achieving overall remission
Time frame: 8 weeks
To assess patients' quality of life
Time frame: 8 weeks
To evaluate change in faecal calprotectin.
Time frame: 8 weeks
To evaluate the safety and tolerability by incidence of AEs.
Time frame: 8 weeks
To evaluate the safety and tolerability by clinically significant laboratory results.
Time frame: 8 weeks
To evaluate the safety and tolerability by assessing clinically significant vital signs results.
Time frame: 8 weeks
To evaluate the safety and tolerability by clinically significant physical examination findings.
Time frame: 8 weeks
To evaluate the safety and tolerability considering the percentage of patients withdrawn from the trial due to safety concerns.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesalazine in people with Colitis, Ulcerative, run by Faes Farma, S.A..
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 9 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To assess the percentage of patients with clinical remission [Mayo Modified Score (MMS) ≤ 2] and Endoscopic remission [Mayo Endoscopic Score (MES) ≤ 1] after 8 weeks of treatment. (time frame: 8 weeks). 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 Dec 2023.