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

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ClinicalTrials.gov Identifier: NCT02660580
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Plaque Type Psoriasis Moderate to Severe Plaque Psoriasis Drug: MSB11022 Drug: Humira® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Actual Study Start Date : February 16, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arm Intervention/treatment
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.




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018

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