A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment with LT-02 (Delayed Release Phosphatidylcholine Granules) vs. Placebo in Subjects with Ulcerative Colitis Refractory to Standard Treatment with Mesalamine
Purpose of this Study
This study will evaluate an experimental drug called LT-02 (Delayed Release Phosphatidylcholine Granules) for the treatment of Ulcerative Colitis. In a previous study, this drug has shown improvement with the symptoms of people with active Ulcerative Colitis and also in quality of life related to their Ulcerative Colitis.
Study Details
This study will be conducted at approximately 150 sites located in North America, Europe, Asia and Oceania and will involve 510 randomized participants. The study will include participants ages 18-70 who have active UC, are taking Mesalamine and are currently experiencing symptoms. Prometheus Laboratories Inc. (Prometheus) is sponsoring this study and is paying the study doctor and the medical facility to perform this study.
Your participation in this study will last approximately 20 weeks and include 5 study visits to the research center. In addition, you will be contacted by telephone at week 10 (between Visit 4 and Visit 5). Unscheduled visits may occur during the study if necessary.
You will either receive the new drug or you will receive a placebo (granules that look like the study medication, but do not contain any medication). You will be assigned by chance to receive either study drug or placebo. Neither you nor your study doctor will know to which study group you are assigned. In case of an emergency, your study doctor can find out this information.
The study medication will be provided in small packets called sachets. Each sachet will contain LT-02 pellets or placebo pellets. You will be instructed to take two sachets 30 to 60 minutes before meals along with a glass of water. Alternatively, you may also mix the contents of the sachet with water, juice, milk, or yogurt. You will be asked to use 2 sachets in the morning and 2 sachets in the evening.
At the end of study, you will have the option to exit the study and receive no other study drug/placebo, or exit the study and enroll in a separate “open label” study. Open label (OL) means that you will receive the experimental drug (LT-02) with or without mesalamine, depending on if it is determined that your UC is no longer actively flaring. You will be provided with another Letter of Information and Consent Form to read and sign if you choose to participate in the “open label” study. If you do not choose to continue in the “open label” study, you will be asked to return for a final study visit, 4 weeks after you stop the study drug.
Watch an excellent video on Ulcerative Colitis HERE.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study you may also fill out the online application HERE.