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

Completed · Phase 1 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03922607

Run by

AbbVie

People needed

65

Starts

2019-06-11

Expected to finish

2021-04-13

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Total Skin and Beauty Derm Ctr /ID# 222593 — Birmingham, Alabama, United States
• Alliance Dermatology and MOHs /ID# 222622 — Phoenix, Arizona, United States
• Anaheim Clinical Trials LLC /ID# 213645 — Anaheim, California, United States
• Dermatology Res. Assoc., CA /ID# 224980 — Los Angeles, California, United States
• Providence Clinical Research /ID# 213339 — North Hollywood, California, United States
• Advanced Medical Research /ID# 216090 — Sandy Springs, Georgia, United States
• Acpru /Id# 213639 — Grayslake, Illinois, United States
• University of Pittsburgh MC /ID# 224699 — Pittsburgh, Pennsylvania, United States
• PPD PH I Clinical Unit /ID# 213062 — Austin, Texas, United States
• Center for Clinical Studies - Webster TX /ID# 217352 — Webster, Texas, United States

Full record on ClinicalTrials.gov

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