MSB11022 in Moderate to Severe Chronic Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:February 16, 2016
End Date:December 18, 2017

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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

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.


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
We found this trial at
7
sites
Haskovo,
Phone: +359888325384
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Haskovo,
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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San Antonio, TX
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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West Palm Beach, FL
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Coral Gables, Florida 33134
Phone: 3053242110210
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Coral Gables, FL
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Dallas, Texas 75230
Phone: 972-386-7546
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Dallas, TX
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Dallas, Texas 75231
Phone: 214-361-2008
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Dallas, TX
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15 Santa Rosa Street
San Luis Obispo, California 93405
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San Luis Obispo, CA
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