To Evaluate the Safety and Efficacy of PN-943 Treatment in Patients with Moderate to Severe Active Ulcerative Colitis.
Published: 03/09/2021
General Information:
Study Objective
To Evaluate the Safety and Efficacy of PN-943 Treatment in Patients with Moderate to Severe Active Ulcerative Colitis.
Phase of study
Phase 2
RETURN TO TOP
Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
Ulcerative Colitis
Severity
Moderate
Severe
Eligibility Criteria
- Are between 18 to 75 years old
- Have been diagnosed with UC for at least 8 weeks
- Have moderate to severe active UC
- Have increased stool frequency and presence of blood in the stool
- Had a lack of response or failed UC treatments
- Do not have a diagnosis of Crohn’s disease or other types of colitis
RETURN TO TOP
Study Details:
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.
RETURN TO TOP
Contact Information:
Site Locations
Clinical Research Insitute of Michigan
30795 23 Mile Road
Suite 206
Chesterfield,
Michigan 48047
Innovative Medical Research of South Florida, Inc.
20880 West Dixie Highway
Suite 103
Aventura,
Florida 33180
GastroIntestinal BioSciences
5901 W Olympic Blvd
Suite 208
Los Angeles,
California 90036
Digestive Endoscopy Center NG-Gastroenterology Associates of Orangeburg
1131 Cook Rd
Orangeburg,
South Carolina 29118
New Orleans Research Institute-Metropolitan Gastroenterology Associates
4224 Houma Blvd
Suite 400
Metairie,
Louisiana 70006
Southern Therapy and Advanced Research LLC (STAR)
971 Lakeland Drive
Suite 1159
Jackson,
Mississippi 39216
Javara Research c/o Tryon Medical Partners
6060 Piedmont Row Drive South
Charlotte,
North Carolina 28210
Digestive System Healthcare
4450 East Sam Houston Parkway
Pasadena,
Texas 77505
LMG Research
3628 Northwest 7th Street
Miami,
Florida 33125
Texas Gastroentrology Associates
25510 Interstate 45
Ste 100
Spring,
Texas 77388
Central Sooner Research
900 North Porter Avenue
Suite 207
Norman,
Oklahoma 73071
United Medical Doctors
28078 Baxter Road
Suite 530
Murrieta,
California 92563
VVCRD Research
574 Essex St
Corona,
California 92879
Blue Ridge Medical Research
121 Nationwide Drive
Suite A,
Lynchburg,
Virginia 24502
Del Sol Research Management, LLC
5700 E. Pima Street
Suite A
Tuscon,
Arizona 85712
Avant Research Associates LLC
912 Bastrop Hwy
Suite 208
Austin,
Texas 78742
RETURN TO TOP