Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMedical University of Lodz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.
Age ≥ 18 years and ≤65 at the time of screening.
In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6 months after receiving the last dose of the drug.
For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient participates in the study and for a period counted from the last dose of 15 weeks if using UST (patients in arms B and C) or 6 months if using IFX (patients in arm A).
Disqualifiers
Previous use of the study drug IFX or UST.
Hypersensitivity to the active substance or excipients.
Moderate or severe myocardial insufficiency (NYHA III or IV).
Unstable coronary artery disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Infliximab
Biological/VaccineInfliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks.
Ustekinumab
Biological/VaccineUstekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight \>55-≤85 kg 390 mg, patients with body weight \>85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks.
Treatment groups
172 Participants
are divided into 3 treatment groupsGroup A: InfliximabActive comparator 1 intervention
Group B: UstekinumabActive comparator 1 intervention
Group C: Infliximab + UstekinumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients with clinical and endoscopic remission after the induction phase.
Clinical remission: PRO-2 score ≤1 points, total Mayo score \<3 Endoscopic remission: endoscopic Mayo score ≤1
Time frame
Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab armsSecondary outcomes
1
Percentage of patients with clinical response after the induction phase.
Clinical response: change in PRO-2 score ≥50% or a change in total Mayo score ≥3 points
Time frame
Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms2
Percentage of patients with clinical response at Week 52.
Clinical response: change in PRO-2 score ≥50% or a change in total Mayo score ≥3 points
Time frame
Week 523
Percentage of patients with clinical remission at Week 52.
Clinical remission: PRO-2 score ≤1 points, total Mayo score \<3
Time frame
Week 524
Percentage of patients with endoscopic response or remission after the induction phase and at Week 52
Endoscopic response: change in endoscopic Mayo score ≥1 point Endoscopic remission: endoscopic Mayo score ≤1
Time frame
Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Lodz
Lead sponsor
Poznan University of Medical Sciences
Collaborator
Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
Collaborator
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Collaborator
Medical Research Agency, Poland
Collaborator
Source ClinicalTrials.gov