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Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

NCT02647866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-04-26

Study results available
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Summary

The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.

Conditions

Interventions

DRUG

KHK4083

IV Infusion

DRUG

Placebo

IV Infusion

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Vincent Strout, MBA · Kyowa Kirin, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-09-30
Completion
2018-10-31

Countries

  • United States
  • Czechia
  • Hungary
  • Poland
  • Romania
  • Russia
  • Serbia

Study Locations

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Entities

Drugs
Diseases

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 NCT02647866 on ClinicalTrials.gov