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

Fresenius Kabi

Status and phase: Completed; Phase 3

Conditions: Psoriasis; Moderate to Severe Plaque Psoriasis; Plaque Type Psoriasis

Treatments: Drug: MSB11022; Drug: Humira®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02660580

EMR200588-002

2015-003287-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants 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
• Participants must not have received more than 1 biologic therapy
• Other protocol-defined inclusion criteria could apply

Exclusion criteria

• Participants was 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
• Participants 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
• Participants was 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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443 participants in 5 patient groups

MSB11022 (Core Treatment Period)

Experimental group

Description:

Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

Treatment:

Drug: MSB11022

EU-Humira

Active Comparator group

Description:

Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

Treatment:

Drug: Humira®

MSB11022 (Extended Treatment Period)

Experimental group

Description:

Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

Treatment:

Drug: MSB11022

EU-Humira/EU-Humira

Active Comparator group

Description:

Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.

Treatment:

Drug: Humira®

EU-Humira/MSB11022

Experimental group

Description:

Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

Treatment:

Drug: Humira®

Drug: MSB11022