Rupatadine added to mesalamine for ulcerative colitis

Clinical Study to Evaluate Safety and Efficacy of Rupatadine in Patients With Ulcerative Colitis.

This trial will test whether adding rupatadine to standard mesalamine improves symptoms and inflammation in adults with mild-to-moderate ulcerative colitis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Alexandria University (Academic / other)
• Locations: 1 site (Alexandria)
• Trial ID: NCT07064707 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial testing rupatadine given alongside mesalamine in adults with mild-to-moderate ulcerative colitis confirmed by endoscopy and histopathology. Eligible participants are aged 18 or older and must not be receiving systemic steroids, immunosuppressives, or biologic therapies. Pregnant or breastfeeding individuals, patients with severe UC, colorectal cancer, or known allergy to the study medications are excluded. The registry summary does not specify randomization or blinding details, and efficacy endpoints are not provided in the brief listing.

Who should consider this trial

Good fit: Adults (≥18) with endoscopy- and biopsy-confirmed mild-to-moderate ulcerative colitis who are not pregnant or breastfeeding and are not taking systemic steroids, immunosuppressives, or biologic therapies are the intended participants.

Not a fit: Patients with severe ulcerative colitis, those on systemic steroids, immunosuppressives, or biologic treatments, pregnant or breastfeeding people, colorectal cancer patients, or anyone allergic to the study drugs are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, rupatadine could provide a well-tolerated oral add-on that reduces inflammation and symptoms for patients with mild-to-moderate UC.

How similar studies have performed: Applying rupatadine to ulcerative colitis is a novel approach with limited prior clinical evidence, though antihistamine and platelet-activating-factor–targeting strategies have been explored preclinically.

Eligibility criteria

Inclusion criteria:

* Age ≥ 18 years
* Both male and female will be included
* Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.

Exclusion criteria:

* Breast feeding or pregnancy.
* Colorectal cancer patients.
* Patients with severe UC.
* Patients taking rectal or systemic steroids.
* Patients taking immunosuppressives or biological therapies.
* Addiction to alcohol and / or drugs.
* Known allergy to the studied medications.

Where this trial is running

Alexandria

• Alexandria University — Alexandria, Egypt (Recruiting)

Study contacts

• Study coordinator: Reham Elshafiey, PhD

Conditions Ulcerative Colitis