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NCT03290781 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
366
Enrollment target

NCT03290781 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 366 participants.

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The verdict

NCT03290781, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
366 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Interventions

  • OTHER Placebo
  • DRUG Ontamalimab

Trial Details

FieldValue
Enrollment Target 366 participants
Start Date 2018-04-04
Est. Completion 2021-07-01
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT03290781

The ClinicalTrials.gov registry entry for NCT03290781 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03290781 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03290781 about?

NCT03290781 is a clinical study titled "An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis". The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

What is the current status of trial NCT03290781?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2018-04-04. Estimated completion is 2021-07-01.

What interventions are being tested in trial NCT03290781?

The interventions under investigation include: Placebo (OTHER), Ontamalimab (DRUG).

Who is sponsoring clinical trial NCT03290781?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.