CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 443 enrolled
Drug / intervention
MSB11022 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02660580
NCT02660580Phase 3Completed
CompareCT.gov

A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Fresenius Kabi SwissBioSim GmbH·interventional·Posted Jan 21, 2016·Updated Dec 27, 2023

In Brief

A Phase 3 clinical trial evaluating MSB11022 and Humira® for Psoriasis and 2 related conditions. Completed, enrolled 443 participants across 76 sites in 12 countries.

Detailed Summary

The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis, Plaque Type Psoriasis, Moderate to Severe Plaque Psoriasis
CountriesBulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Mexico, Poland, Russia, United Kingdom, United States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 21, 2016
Enrollment StartFeb 16, 2016
Primary CompletionDec 31, 2016
Study CompletionDec 18, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.4 years ago

Interventions

MSB11022drug

Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.

Humira®drug

Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.