Men and women over the age of 18 are eligible to participate in this study. Consult with your doctor and for more information click here
Participants must be able to provide a signed informed consent form.
Participants must have a confirmed diagnosis of moderate to severe ulcerative colitis extending no more than 15 cm (5.9 inches) from the anal verge confirmed by sigmoidoscopy.
Participants may have a history of more extensive disease diagnosis in the past but at the time of enrollment, only patients with active ulcerative colitis limited to the rectum are eligible for participation.
Men and women of childbearing potential must be either sexually inactive or agree to use acceptable methods of birth control for a minimum of 21 days prior to the study start and throughout the treatment period.
Participants willing to abstain from receiving anal sex, anal bleaching and waxing, etc.
History or current diagnosis of bacterial or other infectious colitis, radiation-enteritis and radiation-proctitis, Crohn’s Disease, collagenous colitis and indeterminate colitis, recurrent pancreatic disease, sclerosing cholangitis, cirrhosis or hepatic impairment, avascular necrosis of the hip.
Prior excluded gastrointestinal surgery, other active gastrointestinal disease (except Irritable Bowel Syndrome) or distorted intestinal anatomy.
Bleeding hemorrhoids or active systemic infection at the time of enrollment.
History of recurrent diverticulitis and/or diverticulitis at the time of enrollment.
History of previously diagnosed severe, progressive or uncontrolled diseases listed in the study protocol as exclusion criteria.
Clinically significant ECG abnormality, or abnormal liver function profile at screening.
Serum hemoglobin levels <7.5 g/dL.
Positive test result at screening for cytomegalovirus, tuberculosis, human immunodeficiency virus, hepatitis B or C infection.
Diagnosis of Addison’s disease, congenital adrenal hyperplasia or other form of adrenal insufficiency.
History of non-responsive ulcerative colitis to steroid treatment.
Positive stool test at screening for enteric pathogens, clostridium difficile, or presence of ova and parasites.
Pregnant or lactating females at the time of screening.
Participation in another research study for an investigational drug within 30 days of the Screening Visit and during the study.
To learn more about what’s involved in the study, and what study participants will need to do, click here
Currently recruiting at clinical research sites around the world.
To find a research site near you, please click here
Cristcot HCA LLC 9 Damonmill Square, Suite 4A, Concord, MA 01742 USA
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cessa is the name of an ongoing clinical trial for people with ulcerative colitis.
It is not a commercially available treatment.
If you are experiencing symptoms related to IBD, contact your gastroenterologist.