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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Placebo for ABBV-157; Drug: ABBV-157

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922607

M17-238

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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65 participants in 5 patient groups

Substudy 2: Group 2

Experimental group

Description:

Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28

Treatment:

Drug: ABBV-157

Drug: Placebo for ABBV-157

Substudy 2: Group 1

Experimental group

Description:

Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28

Treatment:

Drug: ABBV-157

Drug: Placebo for ABBV-157

Substudy 1: Group 3

Experimental group

Description:

Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14

Treatment:

Drug: ABBV-157

Drug: Placebo for ABBV-157

Substudy 1: Group 2

Experimental group

Description:

Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14

Treatment:

Drug: ABBV-157

Drug: Placebo for ABBV-157

Substudy 1: Group 1

Experimental group

Description:

Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14

Treatment:

Drug: ABBV-157

Drug: Placebo for ABBV-157