Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.

NCT06176560 | Unknown Phase 3

• 1 other identifier: CGRA-0121/ES
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (14)

• To assess the percentage of patients achieving symptomatic remission using Modified Mayo Score.

  8 weeks

• To assess the percentage of patients achieving endoscopic remission using Mayo Endoscopic Score.

  8 weeks

• To assess the percentage of patients achieving overall response using Mayo Modified Score

  8 weeks

• To evaluate changes in the symptomatic assessments using Mayo Modified Score.

  8 weeks

• To evaluate changes in the endoscopic score using Mayo Endoscopic Score.

  8 weeks

Study Arms (2)

Mesalazine Experimental

EXPERIMENTAL

Mesalazine oral formulation

Drug: Mesalazine

Mesalazine Comparator

ACTIVE COMPARATOR

Mesalazine oral formulation

Drug: Mesalazine

Interventions

Mesalazine DRUG

Oral Formulation

Mesalazine Comparator; Mesalazine Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Faes Farma, S.A.: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 19, 2023
• Study Start: March 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share