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

May 7, 2021 updated by: AbbVie

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Subjects With Chronic Plaque Psoriasis

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin and Beauty Derm Ctr /ID# 222593
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology and MOHs /ID# 222622
    • California
      • Anaheim, California, United States, 92801-2658
        • Anaheim Clinical Trials LLC /ID# 213645
      • Los Angeles, California, United States, 90045
        • Dermatology Res. Assoc., CA /ID# 224980
      • North Hollywood, California, United States, 91606
        • Providence Clinical Research /ID# 213339
    • Georgia
      • Sandy Springs, Georgia, United States, 30328-6141
        • Advanced Medical Research /ID# 216090
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Acpru /Id# 213639
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh MC /ID# 224699
    • Texas
      • Austin, Texas, United States, 78744
        • PPD PH I Clinical Unit /ID# 213062
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies - Webster TX /ID# 217352

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: ABBV-157
ABBV-157 will be administered orally as capsule
Drug: Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule
Experimental: 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
Drug: ABBV-157
ABBV-157 will be administered orally as capsule
Drug: Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule
Experimental: 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
Drug: ABBV-157
ABBV-157 will be administered orally as capsule
Drug: Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule
Experimental: 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
Drug: ABBV-157
ABBV-157 will be administered orally as capsule
Drug: Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule
Experimental: 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
Drug: ABBV-157
ABBV-157 will be administered orally as capsule
Drug: Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Substudy 1: Cmax of ABBV-157
Time Frame: Up to approximately 14 days
Maximum observed plasma concentration (Cmax) of ABBV-157
Up to approximately 14 days
Substudy 1: Tmax of ABBV-157
Time Frame: Up to approximately 14 days
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Up to approximately 14 days
Substudy 1: AUC0-24 Post-dose of ABBV-157
Time Frame: Day 1
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Day 1
Substudy 1: Trough Concentration (Ctrough) of ABBV-157
Time Frame: Up to approximately 14 days
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Up to approximately 14 days
Substudy 1: AUCtau of ABBV-157
Time Frame: Up to approximately 14 days
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Up to approximately 14 days
Substudy 1: Apparent Oral Clearance (CL/F)
Time Frame: Day 14
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Day 14
Substudy 1: Volume of Distribution (Vβ/F)
Time Frame: Day 14
Volume of Distribution (Vβ/F) of ABBV-157
Day 14
Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Time Frame: Day 14
Apparent Terminal phase elimination rate constant (β or Beta)
Day 14
Substudy 1: Elimination Half-Life (t1/2)
Time Frame: Day 14
Terminal phase elimination half-life (t1/2) of ABBV-157
Day 14
Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Time Frame: Day 14
Fraction excreted unchanged in urine (fe)
Day 14
Substudy 1: Apparent Renal Clearance (CLR)
Time Frame: Day 14
Apparent Renal Clearance (CLR) of ABBV-157
Day 14
Substudy 1: Accumulation ratio for Cmax
Time Frame: Up to approximately 14 days
Accumulation ratio for Cmax
Up to approximately 14 days
Substudy 1: Accumulation Ratio for AUCtau
Time Frame: Up to approximately 14 days
Accumulation Ratio for AUCtau
Up to approximately 14 days
Substudy 2: Cmax of ABBV-157
Time Frame: Up to approximately 28 days
Maximum observed plasma concentration (Cmax) of ABBV-157
Up to approximately 28 days
Substudy 2: Tmax of ABBV-157
Time Frame: Up to approximately 28 days
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Up to approximately 28 days
Substudy 2: AUC0-24 Post-dose of ABBV-157
Time Frame: Day 1
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Day 1
Substudy 2: AUCtau of ABBV-157
Time Frame: Day 28
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Day 28
Substudy 2: Apparent Oral Clearance (CL/F)
Time Frame: Day 28
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Day 28
Substudy 2: Volume of Distribution (Vβ/F)
Time Frame: Day 28
Volume of Distribution (Vβ/F) of ABBV-157
Day 28
Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Time Frame: Day 28
Apparent Terminal phase elimination rate constant (β or Beta)
Day 28
Substudy 2: Elimination Half-Life (t1/2)
Time Frame: Day 28
Terminal phase elimination half-life (t1/2) of ABBV-157
Day 28
Substudy 2: Accumulation ratio for Cmax
Time Frame: Up to approximately 28 days
Accumulation ratio for Cmax
Up to approximately 28 days
Substudy 2: Accumulation Ratio for AUCtau
Time Frame: Up to approximately 28 days
Accumulation Ratio for AUCtau
Up to approximately 28 days
Substudy 2: Trough Concentration (Ctrough) of ABBV-157
Time Frame: Up to approximately 28 days
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Up to approximately 28 days
Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline
Time Frame: Up to approximately 28 days
Psoriasis Area and Severity Index (PASI) score quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.
Up to approximately 28 days
Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline
Time Frame: Up to approximately 28 days
SAPS is a self-assessment questionnaire of psoriasis symptoms.
Up to approximately 28 days
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Day 58
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to Day 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M17-238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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