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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2021-04-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis

NCT03145948

Psoriasis

TERMINATED PHASE1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type Psoriasis

NCT03337022

Psoriasis

COMPLETED PHASE1

A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis

NCT01700985

Psoriasis Plaque Psoriasis

COMPLETED PHASE2

Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis

NCT03706209

Psoriasis

COMPLETED PHASE2

A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

NCT00277225

Psoriasis Vulgaris

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Substudy 2: Group 2

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

Group Type EXPERIMENTAL

ABBV-157

Intervention Type DRUG

ABBV-157 will be administered orally as capsule

Placebo for ABBV-157

Intervention Type DRUG

Placebo for ABBV-157 will be administered orally as capsule

Substudy 2: Group 1

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

Group Type EXPERIMENTAL

ABBV-157

Intervention Type DRUG

ABBV-157 will be administered orally as capsule

Placebo for ABBV-157

Intervention Type DRUG

Placebo for ABBV-157 will be administered orally as capsule

Substudy 1: Group 3

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

Group Type EXPERIMENTAL

ABBV-157

Intervention Type DRUG

ABBV-157 will be administered orally as capsule

Placebo for ABBV-157

Intervention Type DRUG

Placebo for ABBV-157 will be administered orally as capsule

Substudy 1: Group 2

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

Group Type EXPERIMENTAL

ABBV-157

Intervention Type DRUG

ABBV-157 will be administered orally as capsule

Placebo for ABBV-157

Intervention Type DRUG

Placebo for ABBV-157 will be administered orally as capsule

Substudy 1: Group 1

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

Group Type EXPERIMENTAL

ABBV-157

Intervention Type DRUG

ABBV-157 will be administered orally as capsule

Placebo for ABBV-157

Intervention Type DRUG

Placebo for ABBV-157 will be administered orally as capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABBV-157

ABBV-157 will be administered orally as capsule

Intervention Type DRUG

Placebo for ABBV-157

Placebo for ABBV-157 will be administered orally as capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes