How long is the study?
The study could last up to approximately 68 weeks in total (around 15 months).
Complete this brief questionnaire
Check eligibilityLearn more about
a clinical study for ulcerative colitis
This study is enrolling adults with moderately to severely active ulcerative colitis (UC) with an eosinophilic phenotype who have uncontrolled disease.
Sanofi believes that everyone should have the opportunity to take part in clinical trials. It is important to include people who have been historically under-represented in clinical trials. Sanofi is committed to inclusivity in our studies.
If you are interested in learning more about this study, we encourage you to complete a brief questionnaire to help determine if you are eligible to participate and be referred to a site recruiting in your area for further evaluation.
Am I eligible?What is the purpose of the study?
To evaluate how effective and safe Dupilumab is at relieving symptoms of UC and reducing inflammation in the colon in adult patients.
What is the investigational medication?
The investigational medication is intended to influence your immune system to reduce inflammation and help return your colon to a more normal and healthy state, which can improve signs and symptoms of UC.
The investigational medication can only be used in a research study like this one and therefore, the investigational medication is not approved for treating people with UC in an everyday clinical setting.
The investigational medication is randomly assigned (like flipping a coin). You have a 1:3 chance of receiving either the investigational medication or placebo. Whichever you are assigned, will be taken as an injection under the skin (subcutaneously), every week.
Study Information
How many study visits will there be?
Each participant will have between 6-7 clinic visits during the study.
Additional visits may be required if the study doctor considers them necessary for your safety.
How many participants are in the study?
This study will include about 84 participants at about 90 clinics around the world.
Terms to know
What is an investigational medication?
This is the medication being studied to see if patient symptoms improve while taking it.
The medication is not yet approved for general use by regulatory authorities, like the FDA.
What is a placebo?
A placebo is an inactive substance or treatment that looks the same and is given in the same way as the investigational medication that is being studied.
What is an eosinophilic phenotype?
An eosinophilic phenotype means that your UC may be caused by a specific group of white blood cells leading to inflammation in your colon.
What is expected if I qualify and decide to participate?
- To attend the scheduled visits and allow the tests or procedures to be performed as planned.
- To complete tests during study visits, such as: physical examination, vital signs, electrocardiogram, endoscopy with biopsies, blood tests and patient questionnaires.
- To complete the study electronic diary to record investigational medication administration and symptom questionnaire responses.
- To inform the study doctor or study staff before stopping or modifying your medication(s) or before starting any new medications(s).
- To follow the study doctor’s instructions regarding the investigational medication administration.
FAQ
What type of study-related medical care is provided during the study?
All study-related medical care related to the study is provided, including study-related exams, study-related medications and other study-related medical care. There is no insurance required to participate. All study-related medical care will be explained.
Studies may also offer compensation in return for travel.
Can I speak with someone if I have questions?
Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask questions at any time, before deciding to participate and during study conduct.
Am I eligible?
Complete this brief questionnaire (approximately 5 minutes) to determine if you are eligible to participate in this clinical study and be referred to a site recruiting in/near your area.
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