To Evaluate the Safety and Efficacy of PN-943 Treatment in Patients with Moderate to Severe Active Ulcerative Colitis.

Study Description:

• The IDEAL study is a two-part global study assessing the safety and effectiveness of an oral investigational study drug given as a tablet for adults with moderate to severe active UC.
• Part 1 will last approximately 21 weeks and will require up to 7 study visits.
• If eligible, you may participate in Part 2, which lasts up to 40 weeks and includes up to 6 study visits.  

Description of treatment or intervention (mechanism of action):

• This tablet is being developed as a potential treatment for UC, because it is designed to block the process causing inflammation in the colon.
• It is anticipated that this blockade may reduce inflammation in the colon, thus reducing the symptoms of UC.
• The drug is intended to act on the lining of the colon with minimum absorption into your body. 

Patient Participation Requirements:

• If you are eligible and decide to participate in the IDEAL study, you could be in the study for up to 61 weeks and receive the following at no cost: 
  • Study-related medical assessments throughout the study.
  • Study drug
  • Follow up visit 4 weeks after stopping the study drug to check on your health.
  • Reimbursement for certain expenses such as travel to and from the study site.

As mentioned above, this study is a two-part study.

• Part 1 will evaluate the safety and effectiveness of an oral investigational tablet, PN-943, compared to placebo (looks like PN-943 but contains no active drug) which will be taken twice daily. You will be assigned by chance (like rolling a die) to receive PN-943 or placebo. You will have a 67% chance (2 out of 3) of receiving PN-943 and a 33% chance (1 out of 3) of receiving placebo.
• Subjects who complete Part 1 and are eligible for Part 2 will all receive PN-943 active study drug.
• There are a total of 13 clinic visits over the course of Part 1 and Part 2.