A study testing duvakitug for patients with moderately to severely active ulcerative colitis

Baseline and treatment start

At the beginning of the study, your current health status will be assessed. This includes evaluating the severity of your ulcerative colitis, which is an inflammatory condition affecting the large intestine.

You will be randomly assigned to receive either duvakitug or a placebo. A placebo is an inactive substance that looks identical to the actual medication but contains no active ingredients. Neither you nor your doctor will know which one you are receiving during the study.

If you are assigned to receive duvakitug, you will receive it as a subcutaneous injection, which means the medication is injected under the skin.

Treatment period

You will continue receiving your assigned treatment throughout the induction phase of the study. An induction phase is the initial treatment period designed to bring the disease under control.

The study medication will be administered according to a specific schedule determined by the study protocol. The exact dosage, frequency, and duration of administration will be provided to you by the study staff.

During this period, your symptoms will be regularly monitored, including stool frequency (how often you have bowel movements), rectal bleeding (bleeding from the rectum), bowel urgency (the sudden need to have a bowel movement), nocturnal bowel movements (bowel movements during the night), and abdominal pain.

Regular assessments

Throughout the study, various assessments will be performed to evaluate how the treatment is affecting your condition.

These assessments will include endoscopic examinations, which involve using a thin, flexible tube with a camera to look inside your large intestine and assess inflammation.

Your symptoms will be evaluated using scoring systems such as the modified Mayo Score, which measures the severity of ulcerative colitis based on stool frequency, rectal bleeding, appearance of the intestinal lining, and overall physician assessment.

You will be asked to complete questionnaires about your quality of life, fatigue levels, and how the disease affects your daily activities. These include the PROMIS-Fatigue questionnaire and the Inflammatory Bowel Disease Questionnaire.

Blood samples will be taken to measure the levels of duvakitug in your bloodstream and to check whether your body has developed any immune response to the medication, known as anti-drug antibodies.

Safety monitoring

Your safety will be continuously monitored throughout the study. Any new health problems or worsening of existing conditions that occur during the study will be recorded as adverse events.

Particular attention will be paid to serious adverse events, which are health problems that require hospitalization or are life-threatening, and to specific adverse events of special interest related to the study medication.

If you experience any side effects or health concerns during the study, these will be documented and managed appropriately.

Any hospitalizations related to ulcerative colitis will be recorded.

Study completion

At the end of the induction period, final assessments will be performed to determine how well the treatment worked.

The results will be evaluated based on whether you achieved clinical remission, which means your symptoms have significantly improved or disappeared, and whether there is improvement in the appearance of your intestinal lining.

Additional outcomes will include whether you achieved clinical response (improvement in symptoms), endoscopic improvement (improvement in the appearance of the intestinal lining), and histological improvement (improvement in tissue samples examined under a microscope).

If you were taking steroids at the start of the study, the results will also consider whether you were able to stop using them while maintaining symptom control.