Ulcerative Colitis (UC)Phase 2UCNCT07333716
Desloratadine in Patients With Ulcerative Colitis
A Phase 2 study testing Desloratadine and mesalamine in people with Ulcerative Colitis (UC) and Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis (UC), Ulcerative Colitis
- What is being tested?
- Desloratadine and mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female sex.
- patients with age ranged from 18 to 65.
- patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
- Patients treated with 5-aminosalisylic acid (mesalamine).
Who cannot join
- Patients with severe UC
- Significant liver or kidney function abnormalities
- Pregnant or lactating females
- Treatment with systemic or rectal steroids
- Treatment with immunosuppressant or biological therapies
- Known allergy to desloratadine or any ingredient in the formulation
Show all 9Show fewer
- Patients with other inflammatory diseases
- Patients with history of colon cancer
- Patients with complete or partial colectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menofia university Hospitals
Shibīn al Kawm, Menofia, 32511
Menofia university Hospitals, +20 48 222 8304, hospuniversity@med.menofia.edu.eg
About this study
Official title: Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.
Read the detailed description
Ulcerative colitis is a chronic inflammatory autoimmune disease affecting the colon. The World Health Organization has classified it as a relatively new treatment-resistant disease, and its prevalence has reportedly increased significantly in Egypt. A preclinical study was conducted to evaluate desloratadine as a potential therapeutic agent for ulcerative colitis, based on its known anti-inflammatory and antioxidant properties. The study concluded that desloratadine effectively alleviated experimental ulcerative colitis. This positive effect is attributed to its anti-inflammatory and antioxidant properties, which work by regulating mast cell activity and inhibiting histamine release.
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis
- Being tested
- Desloratadine, mesalamine
- Keywords
- Ulcerative Colitis, Desloratadine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months.
mesalamineDrug
mesalamine 1000 mg three times daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control group) | Placebo comparator | which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group Receives: Drug: mesalamine |
| Group II (Desloratadine group) | Active comparator | which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity and severity
Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification
Measured: over a 3 month follow -up period
Secondary outcomes (1)
Change in serum biomarkers
Change in serum biomarkers of inflammation and oxidative stress (TNF-α \& MDA)
Measured: Change from baseline in serum biomarker over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start26 Jan 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romisaa Raafat Abd Alnapy Mohamed, Tanta University
- Investigators
- Romisaa R Abd Alnapy, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333716
- Sponsor's protocol ID
- 12/2025 TRop1
- Acronym
- UC
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07333716
- Acronym / sponsor ID
- UC / 12/2025 TRop1
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Desloratadine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Jan 2026 (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.
The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.
Detailed description
Ulcerative colitis is a chronic inflammatory autoimmune disease affecting the colon. The World Health Organization has classified it as a relatively new treatment-resistant disease, and its prevalence has reportedly increased significantly in Egypt. A preclinical study was conducted to evaluate desloratadine as a potential therapeutic agent for ulcerative colitis, based on its known anti-inflammatory and antioxidant properties. The study concluded that desloratadine effectively alleviated experimental ulcerative colitis. This positive effect is attributed to its anti-inflammatory and antioxidant properties, which work by regulating mast cell activity and inhibiting histamine release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Control group) | Placebo comparator | Drug: mesalaminewhich will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group |
| Group II (Desloratadine group) | Active comparator | Drug: Desloratadinewhich will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both male and female sex.
- patients with age ranged from 18 to 65.
- patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
- Patients treated with 5-aminosalisylic acid (mesalamine).
Key exclusion criteria (9 listed)
- Patients with severe UC
- Significant liver or kidney function abnormalities
- Pregnant or lactating females
- Treatment with systemic or rectal steroids
- Treatment with immunosuppressant or biological therapies
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 |
|---|---|---|
| Desloratadinemesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months. | Drug | Group II (Desloratadine group) |
| mesalaminemesalamine 1000 mg three times daily for 3 months | Drug | Group I (Control group) |
Primary outcome
Change in disease activity and severity
Time frame: over a 3 month follow -up period
Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification
1 secondary outcome
Change in serum biomarkers
Time frame: Change from baseline in serum biomarker over 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- 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.
Romisaa R Abd Alnapy principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desloratadine and mesalamine in people with Ulcerative Colitis (UC) and Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romisaa R Abd Alnapy (+201288667650, PG_182624@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity and severity (time frame: over a 3 month follow -up period). 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 29 Jan 2026.