A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis

Study Identifier
M17-238
CT.gov Identifier
NCT03922607
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • ABBV-157
  • Placebo for ABBV-157
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Volunteer should be between 18 and 55 years of age and in general good health for Substudy 1 and participant with moderate to severe chronic plaque psoriasis between 18 and 75 years of age for Substudy 2 at the time of enrollment. * Participant should meet the laboratory assessments as mentioned in the protocol.
    Exclusion Criteria:
    * Participant has a history of epilepsy, any significant cardiac, respiratory, renal, hepatic, gastrointestinal, opthalmologic, hematologic,or psychiatric disease or disorder, or any uncontrolled medical illness.

    Protocol Summary

    This is a study to evaluate pharmacokinetics (PK), safety and tolerability of ABBV-157 in healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the efficacy of ABBV-157 in the participants with psoriasis. This study consists of two substudies. Substudy 1 is a randomized, double-blind, placebo-controlled evaluation of multiple ascending oral doses of ABBV-157 in healthy adult volunteers. Substudy 2 is a randomized, double-blind, placebo-controlled study in which participants with moderate to severe chronic plaque psoriasis will be administered multiple oral doses of ABBV-157.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Derm Ctr /ID# 222593
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Alliance Dermatology and MOHs /ID# 222622
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Anaheim Clinical Trials LLC /ID# 213645
    Anaheim, California, United States, 92801-2658
    Status
    Not applicable
    Location
    Dermatology Res. Assoc., CA /ID# 224980
    Los Angeles, California, United States, 90045
    Status
    Not applicable
    Location
    Providence Clinical Research /ID# 213339
    North Hollywood, California, United States, 91606
    Status
    Not applicable
    Location
    Advanced Medical Research /ID# 216090
    Sandy Springs, Georgia, United States, 30328-6141
    Status
    Not applicable
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