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NCT03283085 · ClinicalTrials.gov registry record · Phase 3

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
557
Enrollment target

NCT03283085 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 557 participants.

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The verdict

NCT03283085, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
557 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

Interventions

  • DRUG 25 mg Ontamalimab
  • DRUG 75 mg Ontamalimab

Trial Details

FieldValue
Enrollment Target 557 participants
Start Date 2018-02-27
Est. Completion 2023-12-13
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT03283085

The ClinicalTrials.gov registry entry for NCT03283085 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 557 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 25 mg Ontamalimab is the first listed.

NCT03283085 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03283085 about?

NCT03283085 is a clinical study titled "A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)". The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

What is the current status of trial NCT03283085?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2018-02-27. Estimated completion is 2023-12-13.

What interventions are being tested in trial NCT03283085?

The interventions under investigation include: 25 mg Ontamalimab (DRUG), 75 mg Ontamalimab (DRUG).

Who is sponsoring clinical trial NCT03283085?

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.