Trial record 1 of 3 for: MSB11022

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MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (AURIEL-PsO)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Merck KGaA

Information provided by (Responsible Party):

EMD Serono ( EMD Serono Research & Development Institute, Inc. )

ClinicalTrials.gov Identifier:

NCT02660580

First received: January 17, 2016

Last updated: June 29, 2017

Last verified: June 2017

History of Changes

Purpose

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

Condition	Intervention	Phase
Psoriasis Plaque Type Psoriasis Moderate to Severe Plaque Psoriasis	Drug: MSB11022 Drug: Humira®	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):

Primary Outcome Measures:

Number of subjects With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures:

Percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Baseline, Week 16 ]
Patient's health related quality of life (HRQoL) [ Time Frame: Week 16, 24, and 52 ]
Number of subjects with adverse events (AEs), and serious AEs [ Time Frame: Through 52 weeks ]
Presence of anti-drug antibodies (ADA) [ Time Frame: From Screening to Week 52 ]
Pharmacokinetics parameters: evaluation of drug levels in serum [ Time Frame: From Week 1 to Week 52 ]


Enrollment:	443
Actual Study Start Date:	February 16, 2016
Estimated Study Completion Date:	September 15, 2017
Primary Completion Date:	December 31, 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MSB11022	Drug: MSB11022 MSB11022 will be administered at a dose of 80 milligram (mg) subcutaneously at Week 1, followed by 40 mg every other week starting 1 week after the initial dose up to and including Week 14. At week 16, subjects with a (PASI) 50 response will remain on study for up to 52 weeks.
Active Comparator: Humira®	Drug: Humira® Humira® will be administered at a dose of 80 mg subcutaneously at Week 1, followed by 40 mg every other week starting 1 week after the initial dose up to and including Week 14. At week 16, subjects with a (PASI) 50 response will remain on study for up to 52 weeks; subjects initially randomized to Humira® will be re-randomized (1:1) to MSB11022 or Humira® treatment for weeks 16-52.

Arms

Assigned Interventions

Experimental: MSB11022

Drug: MSB11022

MSB11022 will be administered at a dose of 80 milligram (mg) subcutaneously at Week 1, followed by 40 mg every other week starting 1 week after the initial dose up to and including Week 14. At week 16, subjects with a (PASI) 50 response will remain on study for up to 52 weeks.

Active Comparator: Humira®

Drug: Humira®

Humira® will be administered at a dose of 80 mg subcutaneously at Week 1, followed by 40 mg every other week starting 1 week after the initial dose up to and including Week 14. At week 16, subjects with a (PASI) 50 response will remain on study for up to 52 weeks; subjects initially randomized to Humira® will be re-randomized (1:1) to MSB11022 or Humira® treatment for weeks 16-52.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects greater than or equal to (>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index [PASI] score >=12, Physician Global Assessment [PGA] score >=3, and >=10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
Subjects must not have received more than 1 biologic therapy
Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

Subjects will be excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
Subjects must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
Subjects will also be excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis [TB]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex
Other protocol-defined exclusion criteria could apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02660580

Show 76 Study Locations

Sponsors and Collaborators

EMD Serono Research & Development Institute, Inc.

Merck KGaA

Investigators


Study Director:	Medical Responsible	EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

More Information


Responsible Party:	EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier:	NCT02660580 History of Changes
Other Study ID Numbers:	EMR200588-002 2015-003287-37 ( EudraCT Number )
Study First Received:	January 17, 2016
Last Updated:	June 29, 2017

Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):


Adalimumab MSB11022 Psoriasis Phase III

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases	Adalimumab Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on July 17, 2017

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