Multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the effectiveness and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC)
Published: 11/21/2020
General Information:
Study Objective
Primary objective: To compare clinical efficacy by evaluating the clinical response to CBP-307 (P.O. for 12 consecutive weeks) versus placebo in subjects with moderate to severe UC
Phase of study
Phase 2
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Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
Ulcerative Colitis
Severity
Moderate
Severe
Eligibility Criteria
You may be eligible to take part in this study if you are between 18 and 75 years of age (inclusive), and you:
- Diagnosed with ulcerative colitis for at least 3 months by a doctor
- Your doctor has classified your ulcerative colitis as moderate to severe
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Study Details:
Study Description:
- This study is designed to compare clinical efficacy by evaluating the clinical response to CBP-307 versus placebo in subjects with moderate to severe UC
- Subjects who meet the criteria and participate in this study would receive a maximum of 48 weeks of continuous administration of the drug
- After the subject receives the final dose, they will have an additional 4 weeks of safety follow-up
- CBP-037 is an oral drug that is taken once a day
- Small molecule compound, that does not cause an immune response, and presents with less hypersensitivity
- Lower infection risk comparing with TNF blockers based on UC study of same class drug
- Subjects would be benefit from the regular evaluating of the disease activity
Description of Treatment or intervention (mechanism of action):
- S1P1 mediates T cell egress from lymph nodes into circulation and T cells migrates to tissues to release inflammatory mediators
- CBP-307 causes S1P1 internalization and degradation, trapping T cells inside the lymph nodes
Patient Participation Requirements
If qualified, subjects will be asked to:
- Attend all study visits (how many would they need to attend?)
- Take oral investigational drug as directed
- Have a variety of assessments such as lab tests, vital signs, ECG and Holter, physical exams, and endoscopies performed as required by protocol
- Complete all questionnaires per study requirement or at study visits
Possible risks and side effects:
Heart rate decrease and lymphocyte decrease (especially at the beginning of dosing) were anticipated for this drug and S1P1 products.
Progress to date
https://clinicaltrials.gov/ct2/show/NCT02280434?term=CBP-307&draw=2&rank=1
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Contact Information:
Site Locations
Endoscopic Research, Inc.
1817 North Mills Avenue
Orlando,
Florida 32803
Sylvia Hercules
Omega Research Kissimmee, LLC
7912 Forest City Road
Suite 101
Orlando,
Florida 32810
Danielle Cortese
Clintheory Healthcare
7350 Sand Lake Commons Blvd.
Suite 2225
Orlando,
Florida 32819
LaShoun Sanders
Digestive Healthcare of Georgia
95 Collier Road NW
Suite 4085
Atlanta,
Georgia 30309
Kurt Rivera
Homestead Associates in Research Inc
27535 S Dixie Hwy
Miami,
Florida 33032
Daydene Ordaz
Northside Gastroenterology
21212 Northwest Freeway
Suite 625
Cypress,
Texas 77429
Syed Mustafa
Sweet Hope Research Specialty, Inc.
7100 West 20 Avenue
Suite 411
Hialeah,
Florida 33016
Lisley Avila
Consultants for Clinical Research Inc.
2925 Vernon Place
Suite 200
Cincinnati,
Ohio 45219
Jennifer Pairan
Elite Clinical Studies LLC
4520 E. Indian School Road
Suite # 1
Pheonix,
Arizona 85018
Nicole Ossino
Pharmax Research Clinic
7200 NW 7th Street
Suite 350
Miami,
Florida 33126
Andres Isla
Southern Star Research Institute, LLC
2833 Babcock Rd
Suite 206
San Antonio,
Texas 78229
Mireya Garza
I.H.S Health, LLC
445 W Oak Street
Kissimmee,
Florida 34741
Natasha Contreras
Hightower Clinical
535 NW 9th Street
Suite 235
Oklahoma City,
Oklahoma 73102
Jennifer Kirkwood
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