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NCT02611830 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
383
Enrollment target

NCT02611830 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 383 participants.

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The verdict

NCT02611830, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
383 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Interventions

  • DRUG Placebo IV
  • DRUG Placebo SC
  • DRUG Vedolizumab 300 mg IV
  • DRUG Vedolizumab 108 mg SC

Trial Details

FieldValue
Enrollment Target 383 participants
Start Date 2015-12-18
Est. Completion 2018-08-21
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT02611830

The ClinicalTrials.gov registry entry for NCT02611830 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 383 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo IV is the first listed.

NCT02611830 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02611830 about?

NCT02611830 is a clinical study titled "Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis". The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intr...

What is the current status of trial NCT02611830?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 383 participants. The study started on 2015-12-18. Estimated completion is 2018-08-21.

What interventions are being tested in trial NCT02611830?

The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), Vedolizumab 300 mg IV (DRUG), Vedolizumab 108 mg SC (DRUG).

Who is sponsoring clinical trial NCT02611830?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

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

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.