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Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

NCT03259334 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2021-06-14

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Conditions

Interventions

DRUG

Ontamalimab

Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

OTHER

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2020-07-22
Completion
2020-10-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Croatia
  • Czechia
  • Germany
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT03259334 on ClinicalTrials.gov