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A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)

NCT04700449 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-05-06

Study results available
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Summary

This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).

Conditions

  • Moderate to Severe Ulcerative Colitis

Interventions

DRUG

Double-Blind 0.2mg CBP-307

0.2 mg capsule oral administration

DRUG

Double-Blind Placebo

Placebo capsule oral administration

DRUG

Open-label CBP-307

0.2 mg capsule oral administration

DRUG

Double-Blind 0.1mg CBP-307

0.1 mg capsule oral administration

Sponsors & Collaborators

  • Connect Biopharm LLC

    lead INDUSTRY

Principal Investigators

  • Suzhou Connect · Connect Biopharm LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2022-02-23
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States
  • China
  • Pakistan
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700449 on ClinicalTrials.gov