Possibia

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Recruiting

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Surrey Memorial Hospital
Canada
Surrey, B.C., V2Y 1K1
Surrey Memorial Hospital
Norway
Oslo, Oslo, 0265

What is the potential treatment?

Tulisokibart is a potential treatment developed to manage active, moderate to severe UC. Researchers aim to determine how well this treatment works and whether more people receiving the medication experience symptom relief compared to those receiving a placebo. A placebo contains no active substance. The use of a placebo helps researchers better understand the effectiveness of the new treatment.

Ulcerative Colitis (UC)

UC is an inflammatory bowel disease (IBD) that causes swelling and ulcers in the digestive tract. It affects the lining of the colon, including the rectum. People with ulcerative colitis often experience periods with few or no symptoms, followed by periods of symptom flare-ups. The disease is rarely life-threatening but can have a significant impact on quality of life. Therefore, finding effective treatment options is important.

What treatments are given in the study?

Participants will receive one or both of the following treatments:

  • Placebo.
  • Tulisokibart, the investigational drug, at different doses.

Both the active drug and placebo will be administered:

  • Intravenously (infusion into a vein).
  • As an injection under the skin at different times during the study.

Example Prescreener

These questions are here to help you determine if you might be eligible for this trial, but it is not conclusive. If you are ever in doubt, please refer to your health care professional.

You may participate in the study if:

  1. You have ulcerative colitis (UC) and have had symptoms for at least 3 months.
  2. You have moderate to severe UC (causing significant symptoms).
  3. You weigh at least 40 kg (88 lbs).
  4. Previous treatments have not worked well, or you have not tolerated them. This includes:
    1. UC medications that were ineffective or stopped working.
    2. The need for regular use of steroids to control symptoms.
    3. Being unable to use certain UC treatments due to side effects.
  5. You are on certain UC medications and meet the study's requirements.
  6. You are 16 or 17 years old, and participation is approved by health authorities.
  7. You are a woman of childbearing age and:
    1. Are not pregnant or breastfeeding.
    2. Use contraception or have chosen long-term abstinence.
    3. Have a negative pregnancy test before the study begins.
    4. Have your medical and menstrual history reviewed by a doctor to reduce the risk of an early, undetected pregnancy.

Contact this trial today!

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What more do I need to know?

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Dr. Jane Smith

Dr. Jane Smith

Prof. PhD. ATLAS-UC Research Lead

Dr. Jane Smith, is a gastroenterologist specializing in Ulcerative Colitis (UC) and inflammatory bowel diseases. With a passion for patient-centered care and cutting-edge research, Dr. Smith focuses on advancing treatments to improve the quality of life for those with UC.

Helpful Information

Regulatory approval

Regulatory approval and further information:

Regulatory Approval