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A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

NCT03653026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2022-03-02

Study results available
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Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Placebo

Tablet for oral administration

DRUG

Upadacitinib

Tablet for oral administration

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2021-01-14
Completion
2021-01-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT03653026 on ClinicalTrials.gov