The Earnest Study is investigating whether Vedolizumab, currently approved for treatment of adult patients with moderately to severely active Crohn’s Disease or Ulcerative Colitis may be effective for chronic or recurrent Pouchitis. 

While a cure for Pouchitis is still not yet available, researchers are working to find a way to treat it. If you’ve been diagnosed with Ulcerative Colitis and currently experience Pouchitis (inflammation of your Pouch), we want to speak to you and see if you might be eligible for the Earnest Study.

There will be approximately 110 patients taking part in this study at approximately 40 study clinics in North America and Europe

Participants will receive all study medication, study-related procedures, and study visits at no cost. No health insurance or referrals are needed. The study will require 1-2 visits a month to a study site in your area.

Volunteers who take part in the study may receive compensation for travel expenses. 

What is Pouchitis?

In patients with severe Ulcerative Colitis (UC) the surgical treatment of choice is removal of the colon followed by creation of an ileal pouch anal anastomosis (IPAA). Inflammation of the “pouch”, commonly called pouchitis, is the most common long-term complication in these patients resulting in watery, sometimes bloody stool associated with urgency, incontinence, abdominal cramps, malaise, and fever that affect quality of life.

There are presently no approved drugs for the treatment or prevention of pouchitis in the United States or Europe.

The Earnest Study is investigating whether Vedolizumab, currently approved for treatment of adult patients with moderately to severely active Crohn’s Disease or Ulcerative Colitis may be effective for chronic or recurrent Pouchitis.

 What is a Clinical research study?

A Clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational medication, such as: does it work? All medications must be tested in Clinical research studies before they can be approved to be prescribed to patients. Without people taking part in these studies, we would have no new medications.

What happens if I sign up?

We will match you or your family member to a Clinical research study in your area that is seeking participants who have undergone surgery for Ulcerative Colitis and frequently suffer from an inflammation to their pouch (Pouchitis) or notify you when one becomes available. They will contact you to explain more about the study before you make your decision about participating. You may attend an in-person screening visit where a Specialist Physician will help determine if the study is right for you.

Frequently Asked Questions


You may be able to take part in the Earnest Study if you:

  • Have undergone surgery for Ulcerative Colitis
  • Have been diagnosed with pouchitis after your Ulcerative Colitis surgery or you suspect that you currently experience pouchitis

Investigational means that vedolizumab has not been approved for the treatment of chronic or recurrent pouchitis. The study sponsor will compare two groups of patients to see if vedolizumab helps your symptoms improve. One group (50% of people) will be given vedolizumab and the other group (50% of people) will receive placebo (a fake medicine).

The study includes up to a 4-week screening period, a 34-week treatment period (with last dose at Week 30), and an 18-week follow-up period following last dose. You will need to visit the clinic approximately 10 times for the study over a 52-week period depending on the scheduling of your study procedure. Procedures may include an endoscopy.

Volunteers who take part in the study may receive compensation for travel expenses.

The study medication, study-related procedures and tests, and study visits will be at no cost.

The study team will be able to explain more about what the Earnest Study will involve and it is up to you to decide if you want to take part. Participation in this study is voluntary. Your decision whether or not to participate in this study will not affect your current or future relations with your physicians. If you decide to participate, you are free to withdraw at any time without affecting those relationships.




See if you Qualify

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