NCT02714322

MYL-1401A Efficacy and Safety Comparability Study to Humira®

Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira® in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis

Detailed description

Eligible subjects will be randomly assigned based on predefined stratification factors of weight, geographic region, and presence of psoriatic arthritis: Randomization is 2:1 to MYL-1401A or Humira®, respectively. The study will be conducted in the outpatient setting and comprises 3 periods: a screening period of up to 4 weeks, a 52-week treatment period, and a safety follow-up for 8 weeks. A subject will be considered to have completed the study once they have completed the 52-week treatment period and the 8-week follow-up visit.

Conditions

• Psoriasis
• Arthritis, Psoriatic

Interventions

Type	Name	Description
BIOLOGICAL	MYL-1401A (Adalimumab)	MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
BIOLOGICAL	Humira® (Adalimumab)	Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-05-01
• Completion: 2017-03-01
• First posted: 2016-03-21
• Last updated: 2022-03-11

Locations

33 sites across 6 countries: Bulgaria, Estonia, Hungary, Poland, Russia, Ukraine