A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥ 18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED) (Study in Ulcerative...)
General Information:
The main purpose of this study is to evaluate the effect of dupilumab on relieving symptoms of ulcerative colitis and reducing inflammation in the colon.
Eligibility:
Select Inclusion Criteria:
- Participants must be at least 18 years of age.
- UC diagnosis for at least 3 months.
- Must be up to date with colon cancer screening
Select Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.
- Participants with abdominal abscess, fulminant disease, or toxic megacolon.
If there are any questions about these criteria, please ask the study doctor.
Study Details:
Study description/explanation of participation:
To see if you are able to enter the study, there will be a screening period of up to 4 weeks. It includes physical exams like you normally have at your doctor’s office, and procedures (including endoscopy with colon biopsies) as well as blood tests and patient questionnaires to find out if you are eligible to enter the study. If you decide to take part, you will be in the study for around 64 weeks. You will receive the placebo or Dupilumab for 24 weeks. At the completion of week 24, if your disease does not improve, you will receive Dupilumab, if you qualify.
You will also be asked to complete a daily electronic diary to collect information about your UC symptoms and you would be requested to complete health related questionnaires.
During the 52-week treatment period, 4 visits to the clinic will be performed. After the treatment period, there will be a 12-week follow-up period.
Description of treatment or intervention (mechanism of action):
Dupilumab is a type of medicine called a “monoclonal antibody."
Dupilumab has been shown to block the action of two proteins called interleukin 4 (IL-4) and interleukin 13 (IL-13). These proteins are thought to cause inflammatory diseases such as eosinophilic esophagitis, asthma and a special type of ulcerative colitis.
Because dupilumab blocks these two proteins, dupilumab may reduce ulcerative colitis disease activity and help patients feel better.
Dupilumab is given by subcutaneous injection (injection under the skin) every week via prefilled syringe.
Patient Participation Requirements:
By agreeing to participate, you agree to:
- Provide truthful information about your medical condition(s) and drug(s) that you have been taking for this (these) condition(s),
- Inform the study doctor before stopping or modifying your treatment(s) or before starting any new treatment(s),
- Attend the scheduled visits and allow the tests or procedures to be performed as planned,
- Follow the study doctor’s instructions regarding the study drug’s administration
- Inform the study doctor or study staff, as soon as possible, of any side effects or health problems even if you do not think they are caused by the study drug(s),
- Complete the electronic diary and/or paper diary as per instructions provided
- Carry the study participation card with you.
Possible risks and side effects:
There is a risk that your underlying ulcerative colitis, for which you are in this study, may not get better or may worsen during the study.
There is a risk that you might experience discomfort or side effects with the use of dupilumab.
The investigational drug, dupilumab, is a protein (human antibody). It is possible that your body may develop antibodies to dupilumab because this is a natural reaction of the body's immune system to foreign substances including human antibodies.
Dupilumab has been generally well tolerated in all populations tested in clinical development programs consistent with a positive benefit/risk profile, including infants as young as 6 months of age.