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History of Changes for Study: NCT02660580
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (AURIEL-PsO)
Latest version (submitted December 13, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 17, 2016 None (earliest Version on record)
2 February 5, 2016 Arms and Interventions, Study Status, Eligibility, Conditions, Study Description and Study Identification
3 February 25, 2016 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations and Oversight
4 March 23, 2016 Contacts/Locations and Study Status
5 April 29, 2016 Contacts/Locations and Study Status
6 May 17, 2016 Contacts/Locations and Study Status
7 June 7, 2016 Contacts/Locations and Study Status
8 July 14, 2016 Study Status and Contacts/Locations
9 November 22, 2016 Sponsor/Collaborators and Study Status
10 January 25, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
11 June 29, 2017 Study Status and Contacts/Locations
12 October 4, 2017 Study Status and Study Design
13 December 21, 2017 Recruitment Status, Study Status and Contacts/Locations
14 February 2, 2018 Study Status
15 July 19, 2018 Study Status and Study Design
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Results Submission Events
16 January 28, 2019 Arms and Interventions, Study Status, Outcome Measures, Results, Eligibility and Study Description
17 June 14, 2019 Sponsor/Collaborators, Study Status, Study Identification and Contacts/Locations
18 June 28, 2019 Contacts/Locations and Study Status
19 December 13, 2019 More Information and Study Status
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Study NCT02660580
Submitted Date:  January 17, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: EMR200588-002
Brief Title: MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (AURIEL-PsO)
Official Title: A Randomized, Double-blind, Confirmatory Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With European Union-Approved Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Secondary IDs: 2015-003287-37 [EudraCT Number]
Open or close this module Study Status
Record Verification: January 2016
Overall Status: Not yet recruiting
Study Start: February 2016
Primary Completion: September 2017 [Anticipated]
Study Completion: September 2017 [Anticipated]
First Submitted: January 17, 2016
First Submitted that
Met QC Criteria:
January 17, 2016
First Posted: January 21, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 17, 2016
Last Update Posted: January 21, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: EMD Serono
Responsible Party: Sponsor
Collaborators: Merck KGaA, Darmstadt, Germany
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to demonstrate equivalence in efficacy and to compare the safety and immunogenicity of an investigational medication called MSB11022 with Humira® in people with plaque psoriasis. Humira® is an approved medication for the treatment of plaque psoriasis. MSB11022 is a biosimilar of adalimumab, which means it is chemically the same as adalimumab but made in a different way. Even though they are chemically same, all biosimilar medications must be tested to make sure they work as well as the original medicine.
Detailed Description:
Open or close this module Conditions
Conditions: Psoriasis
Keywords: Adalimumab
MSB11022
Psoriasis
Phase III
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 406 [Anticipated]
Open or close this module Arms and Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of subjects With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16
[ Time Frame: Week 16 ]

PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicates "no sign of psoriasis" and 72.0 indicates "maximum psoriasis". PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
Secondary Outcome Measures:
1. Percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 16
[ Time Frame: Baseline, Week 16 ]

PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis.
2. Percentage of subjects achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100
[ Time Frame: Week 16 ]

PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis. PASI 50, PASI 90 and PASI 100 response was defined as at least a 50%, 90% and 100% reduction in PASI relative to Baseline, respectively.
3. Percentage of subjects achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90 and PASI 100
[ Time Frame: Week 24, 52 ]

PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis. PASI 50, PASI 75, PASI 90 and PASI 100 response was defined as at least a 50%, 75%, 90% and 100% reduction in PASI relative to Baseline, respectively.
4. Percent change from baseline in Psoriasis Area and Severity Index (PASI)
[ Time Frame: Baseline, Week 24, 52 ]

PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis.
5. Percentage of subjects achieving static Physician Global Assessment (PGA) score of "clear" or "almost clear" compared to baseline
[ Time Frame: Week 16, 24, 52 ]

The PGA is a global static assessment of the overall impression of severity of psoriasis scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe). The subject will be considered a PGA responder if the subject achieves a score of 0 ("clear") or 1 ("almost clear") and improves by at least 2 points of the PGA scale compared to Baseline.
6. Time to achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90 and PASI 100
[ Time Frame: From screening until end of the treatment (4 weeks after the last dose of study drug), assessed up to 20 months ]

The time taken from screening up to the achievement of PASI response of 50%, 75%, 90% and 100%.PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis. PASI 50, PASI 75, PASI 90 and PASI 100 response is defined as at least a 50%, 75%, 90% and 100% reduction in PASI relative to Baseline, respectively
7. Change from baseline in Physician's Global Assessment (PGA)
[ Time Frame: Week 16, 24, 52 ]

The PGA is a global static assessment of the overall impression of severity of psoriasis scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe). The subject will be considered a PGA responder if he or she achieves a score of 0 ("clear") or 1 ("almost clear") and improves by at least 2 points of the PGA scale compared to Baseline.
8. Number of subjects with adverse events (AEs), serious AEs, AEs leading to discontinuation and AEs leading to death
[ Time Frame: Screening until 4 weeks after the last dose of study drug administration, assessed up to 20 months ]

An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE (SAE) is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AE leading to death and discontinuation of the subjects are also presented.
9. Dermatology Life Quality Index (DLQI) score
[ Time Frame: Week 16, 24, 52 ]

The DLQI is a general dermatology questionnaire which consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions will be rated by the subjects as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
10. European Quality of Life 5-dimensions and 5-levels questionnaire (EQ-5D-5L)
[ Time Frame: Week 16, 24, 52 ]

The EQ-5D-5L Health Outcome Questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).
11. Health Assessment Questionnaire Disability Index (HAQ-DI)
[ Time Frame: Weeks 16, 24, 52 ]

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Subjects will assess their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task will be summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
12. Patient Global Assessment for Joints on a Visual Analog Scale (PJA-VAS)
[ Time Frame: Week 16, 24, 52 ]

The patient's assessment of joints will be performed using 100 mm VAS. VAS measured on a scale of 0 (excellent) to 100 (poor) after the question "In all the ways your Arthritis affects you, how would you rate the way you felt over the past week?"
13. Number of subjects with positive and negative anti-drug antibodies (ADA) to MSB11022 and ADA titer
[ Time Frame: From screening until the end of the trial (4 weeks after the last dose of study drug), assessed up to 20 months ]

14. Number of subjects with neutralizing anti-drug antibodies to MSB11022
[ Time Frame: From screening until the end of the trial (4 weeks after the last dose of study drug), assessed up to 20 months ]

15. Observed trough concentration of MSB11022 at steady state
[ Time Frame: Week 1 (Day 1), Week 4, 8, 12, 16, 24, 32, 40, 52 and at the end of the trial (4 weeks after the last dose of study drug) ]

16. Maximum observed serum concentration of MSB11022 at steady state
[ Time Frame: Week 1 (Day 1), Week 4, 8, 12, 16, 24, 32, 40, 52 and at the end of the trial (4 weeks after the last dose of study drug) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 (must have been either etanercept or infliximab) for psoriasis treatment (etanercept must be stopped at least 30 days and infliximab must be stopped at least 60 days prior to randomization)
  • 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
Open or close this module Contacts/Locations
Central Contact Person: US Medical Information
Telephone: 888-275-7376
Central Contact Backup: Merck KGaA Communication Center
Telephone: +49 6151 72 5200
Email: service@merckgroup.com
Study Officials: Medical Responsible
Study Director
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Locations: United States, Massachusetts
U.S. Medical Information
Rockland, Massachusetts, United States
Germany
Merck KGaA Communication Center
Darmstadt, Germany
Open or close this module IPDSharing
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Open or close this module References
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