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NCT02016105 · ClinicalTrials.gov registry record · Phase 3

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

A Phase 3 study, sponsored by Sandoz.

Completed
Registry status
Phase 3
Development phase
465
Enrollment target

NCT02016105 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 465 participants.

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The verdict

NCT02016105, a Phase 3 study, has completed, sponsored by Sandoz.

COMPLETED
Registry status
Phase 3
Development phase
465 participants
Enrollment target

Study Summary

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Interventions

  • DRUG GP2017 Adalimumab
  • DRUG Humira ® Adalimumab

Trial Details

FieldValue
Enrollment Target 465 participants
Start Date 2013-12
Est. Completion 2016-02
Phase Phase 3

Sponsor

Sandoz

29 total trials

What the Registry Record Tells You About NCT02016105

The ClinicalTrials.gov registry entry for NCT02016105 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 465 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which GP2017 Adalimumab is the first listed.

NCT02016105 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02016105 about?

NCT02016105 is a clinical study titled "Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira". The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

What is the current status of trial NCT02016105?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2013-12. Estimated completion is 2016-02.

What interventions are being tested in trial NCT02016105?

The interventions under investigation include: GP2017 Adalimumab (DRUG), Humira ® Adalimumab (DRUG).

Who is sponsoring clinical trial NCT02016105?

This trial is sponsored by Sandoz, which has 29 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.