Actively Recruiting
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
Led by Medical University of Lodz · Updated on 2025-05-15
172
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
M
Medical University of Lodz
Lead Sponsor
P
Poznan University of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are: Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy? Participants: Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab). Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.
CONDITIONS
Official Title
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed written consent to participate in the study and for all planned procedures
- Aged between 18 and 64 years at screening
- For women of reproductive potential, agree not to donate oocytes during the study and for 6 months after the last drug dose
- For women of reproductive potential, agree to use effective contraception during the study and for 15 weeks after last dose if using ustekinumab or 6 months if using infliximab
- Negative pregnancy test in women of childbearing age
- Diagnosed with ulcerative colitis at least 3 months before screening, confirmed by endoscopy and histopathology
- Moderate to severe ulcerative colitis with Mayo scale score of 7 to 12, including specific symptom criteria
- Inadequate response, intolerance, contraindication, or loss of response to standard treatments including corticosteroids and immunosuppressants
- Stable dose of 5-ASA derivatives, corticosteroids, or immunosuppressants for at least 14 days before randomization
You will not qualify if you...
- Previous use of infliximab or ustekinumab
- Allergy to study drugs or their components
- Moderate or severe heart failure (NYHA III or IV)
- Unstable coronary artery disease
- Serious stroke or cerebrovascular disease within 24 weeks before screening
- Chronic respiratory failure
- Severe kidney or liver failure
- Demyelinating syndrome or similar symptoms
- Alcohol-related liver disease
- Cancer diagnosis within 5 years except certain skin and cervical cancers
- Complications requiring surgery
- Recent severe colitis flare, abscess, colonic distension, or perforation within 12 weeks before randomization
- Extensive colorectal surgery or indications for surgery during the study
- Unclassified or ischemic colitis history
- Recent colonic diverticulitis within 60 days before randomization
- Untreated adenomatous polyps or high-grade dysplasia
- Receiving enteral or total parenteral nutrition
- Pregnant or breastfeeding
- Use of prohibited medications
- High-dose corticosteroid use exceeding specified limits
- History of bone marrow transplant or apheresis within 12 months
- Insufficient washout periods after biologic drugs or microbiota transplantation
- Active or latent tuberculosis
- HIV infection
- Treatment for active chronic infections
- Recent infections with HSV, HPV, influenza, or SARS-CoV2 within 12 weeks
- Immunodeficiency history
- Live vaccine within 30 days prior to randomization
- Hepatitis B or C infection
- Significant chest X-ray, ECG, or lab abnormalities
- Positive stool cultures for certain bacteria or fungi
- Use of treatments not allowed by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej USK nr 1 im. N. Barlickiego w Łodzi
Lodz, Poland, 90-153
Actively Recruiting
Research Team
R
Renata Talar-Wojnarowska, Prof.
CONTACT
A
Adam Fabisiak, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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