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Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis

NCT03235752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-01-05

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II study.

Conditions

  • Active Ulcerative Colitis

Interventions

DRUG

TJ301 300mg

TJ301 300mg IV infusion

DRUG

TJ301 600mg

TJ301 600mg IV infusion

DRUG

Placebo

Placebo IV infusion

Sponsors & Collaborators

  • I-Mab Biopharma HongKong Limited

    lead INDUSTRY

Principal Investigators

  • Minhu Chen, Doctor · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2020-12-21
Completion
2020-12-21

Countries

  • China
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT03235752 on ClinicalTrials.gov