Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

Study Identifier
M13-606
CT.gov Identifier
NCT01646073
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • Adalimumab
  • placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Clinical diagnosis of psoriasis for at least 6 months. * Must have stable plaque psoriasis for at least 2 months before screening and baseline visits. * Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit. * Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit. * Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.
    Exclusion Criteria:
    * Diagnosis of other active skin diseases or skin infections. * Participant has known hypersensitivity to adalimumab or it excipients. * Participant has chronic recurring infections or active tuberculosis. * Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease. * Participant is known to have immune deficiency or is immunocompromised.

    Protocol Summary

    A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 72888
    Beijing, China, 100034
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 72873
    Beijing, China, 100044
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 72887
    Beijing, China, 100730
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 85693
    Chengdu, China, 610072
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 72976
    Chongqing, China, 400038
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 72880
    Dalian, China, 116011
    Status
    Not applicable
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