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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

Clinical Research Professionals, Inc. 17998 Chesterfield Airport Road Suite 100 Chesterfield, Missouri 63005
Endoscopic Research, Inc. 1817 North Mills Avenue Orlando, Florida 32803
Omega Research Kissimmee, LLC 7912 Forest City Road Suite 101 Orlando, Florida 32810
Danielle Cortese
[email protected]
DHAT Research Institute 7150 N President George Bush Highway Suite 201 Garland, Texas 75044
Arlen Waclawczyk
[email protected]
Clintheory Healthcare 7350 Sand Lake Commons Blvd. Suite 2225 Orlando, Florida 32819
Dexter Averion
[email protected]
Digestive Healthcare of Georgia 95 Collier Road NW Suite 4085 Atlanta, Georgia 30309
Kurt Rivera
[email protected]
Homestead Associates in Research Inc 27535 S Dixie Hwy Miami, Florida 33032
Daydene Ordaz
[email protected]
Northside Gastroenterology 21212 Northwest Freeway Suite 625 Cypress, Texas 77429
Stephanie Gonzalez
[email protected]
Digestive Disease Specialists, Inc. 3366 Northwest Expy. Suite 400 Oklahoma City, Oklahoma 73122
Heather Lomonaco
[email protected]
Sweet Hope Research Specialty, Inc. 7100 West 20 Avenue Suite 411 Hialeah, Florida 33016
Jose Alvarez
[email protected]
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