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)

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