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COMPLETEDPHASE3

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

NCT02714322•Mylan Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has signed the informed consent form
•2. Subject is aged 18 to 75 years, inclusive, at time of Screening
•3. Subject has had moderate-to-severe chronic plaque psoriasis for at least 6 months
•* Subject has involved BSA ≥10%, PASI ≥12, and sPGA ≥3 (moderate) at Screening and at Baseline
•4. Subject has had stable disease for at least 2 months (i.e. without significant changes as defined by the investigator)
•5. Subject is a candidate for systemic therapy
•6. Subject has had a previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy
•7. Subject is naïve to adalimumab therapy, approved or investigational
•8. For females of childbearing potential, a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline

Exclusion Criteria

•1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (e.g. eczema), or other systemic autoimmune disorder inflammatory disease at the time of the screening visit that would interfere with evaluations of the effect of the study treatment on psoriasis
•2. Subject has used any of the following medications within specified time periods or will require their use during the study:
•* Topical medications within 2 weeks before the end of the screening period
•* oral psoralen with ultraviolet A (PUVA) phototherapy and/or ultraviolet B (UVB) phototherapy within 4 weeks before the end of the screening period
•* Nonbiologic systemic therapies within 4 weeks before the end of the screening period (e.g. cyclosporine, methotrexate, and acitretin)
•* Any prior or concomitant adalimumab therapy, approved or investigational
•* Any other investigational agent within 90 days or 5 half-lives of Screening (whichever is longer)
•* Any systemic steroid in the 4 weeks before the end of the screening period Note: Low-potency topical corticosteroids applied to the palms, soles, face, and intertriginous areas are permitted during study participation
•3. Subject has received live vaccines during the 4 weeks prior to Screening or has the intention of receiving a live vaccine at any time during the study
•4. Subject has a positive test for tuberculosis (TB) during Screening or a known history of active or latent TB, except documented and complete adequate treatment of TB or initiation (\>1 month) of adequate prophylaxis of latent TB, with an isoniazid-based regimen
+23 more criteria

Locations (33)

Mylan Investigational Site 102

Plovdiv, Bulgaria

Mylan Investigational Site 105

Plovdiv, Bulgaria

Mylan Investigational Site 101

Sevlievo, Bulgaria

Mylan Investigational Site 100

Sofia, Bulgaria

Mylan Investigational Site 103

Sofia, Bulgaria

Mylan Investigational Site 107

Tallinn, Estonia

Mylan Investigational Site 108

Tallinn, Estonia

Mylan Investigational Site 109

Tallinn, Estonia

Mylan Investigational site 110

Tallinn, Estonia

Mylan Investigational Site 106

Tartu, Estonia

Key Dates

Start Date

June 1, 2015

Primary Completion Date

May 1, 2016

Completion Date

March 1, 2017

Last Updated

March 11, 2022

Enrollment

294

ACTUAL participants

Conditions

PsoriasisArthritis, Psoriatic

Interventions

MYL-1401A (Adalimumab)

BIOLOGICAL

Humira® (Adalimumab)

BIOLOGICAL

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments