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 |
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.
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
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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7810 Louis Pasteur
San Antonio, Texas 78229
San Antonio, Texas 78229
210-692-1382
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