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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: Completed Phase 3 study, sponsored by Sandoz.
NCT02016105 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 465 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
Interventions
- DRUG GP2017 Adalimumab
- DRUG Humira ® Adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT02016105 record still lists
NCT02016105 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which GP2017 Adalimumab is the first listed.
NCT02016105 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02016105's enrollment target sits among peer trials
465 819th of 2000 higher than 1,180 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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