NCT03922607

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 11, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

April 18, 2019

Last Update Submit

May 7, 2021

Conditions

Psoriasis

Keywords

PsoriasisChronic Plaque PsoriasisABBV-157Healthy Volunteers

Outcome Measures

Primary Outcomes (27)

  • Substudy 1: Cmax of ABBV-157

    Maximum observed plasma concentration (Cmax) of ABBV-157

    Up to approximately 14 days

  • Substudy 1: Tmax of ABBV-157

    Time to maximum observed plasma concentration (Tmax) of ABBV-157

    Up to approximately 14 days

  • Substudy 1: AUC0-24 Post-dose of ABBV-157

    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

    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

    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)

    Clearance is defined as the volume of plasma cleared of the drug per unit time.

    Day 14

  • Substudy 1: Volume of Distribution (Vβ/F)

    Volume of Distribution (Vβ/F) of ABBV-157

    Day 14

  • Substudy 1: Apparent Terminal Phase Elimination Constant (β)

    Apparent Terminal phase elimination rate constant (β or Beta)

    Day 14

  • Substudy 1: Elimination Half-Life (t1/2)

    Terminal phase elimination half-life (t1/2) of ABBV-157

    Day 14

  • Substudy 1: Fraction Excreted Unchanged in Urine (fe)

    Fraction excreted unchanged in urine (fe)

    Day 14

  • Substudy 1: Apparent Renal Clearance (CLR)

    Apparent Renal Clearance (CLR) of ABBV-157

    Day 14

  • Substudy 1: Accumulation ratio for Cmax

    Accumulation ratio for Cmax

    Up to approximately 14 days

  • Substudy 1: Accumulation Ratio for AUCtau

    Accumulation Ratio for AUCtau

    Up to approximately 14 days

  • Substudy 2: Cmax of ABBV-157

    Maximum observed plasma concentration (Cmax) of ABBV-157

    Up to approximately 28 days

  • Substudy 2: Tmax of ABBV-157

    Time to maximum observed plasma concentration (Tmax) of ABBV-157

    Up to approximately 28 days

  • Substudy 2: AUC0-24 Post-dose of ABBV-157

    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

    The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)

    Day 28

  • Substudy 2: Apparent Oral Clearance (CL/F)

    Clearance is defined as the volume of plasma cleared of the drug per unit time.

    Day 28

  • Substudy 2: Volume of Distribution (Vβ/F)

    Volume of Distribution (Vβ/F) of ABBV-157

    Day 28

  • Substudy 2: Apparent Terminal Phase Elimination Constant (β)

    Apparent Terminal phase elimination rate constant (β or Beta)

    Day 28

  • Substudy 2: Elimination Half-Life (t1/2)

    Terminal phase elimination half-life (t1/2) of ABBV-157

    Day 28

  • Substudy 2: Accumulation ratio for Cmax

    Accumulation ratio for Cmax

    Up to approximately 28 days

  • Substudy 2: Accumulation Ratio for AUCtau

    Accumulation Ratio for AUCtau

    Up to approximately 28 days

  • Substudy 2: Trough Concentration (Ctrough) of ABBV-157

    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

    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

    SAPS is a self-assessment questionnaire of psoriasis symptoms.

    Up to approximately 28 days

  • Number of Participants With Adverse Events (AEs)

    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

Study Arms (5)

Substudy 2: Group 2

EXPERIMENTAL

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

Drug: ABBV-157Drug: Placebo for ABBV-157

Substudy 2: Group 1

EXPERIMENTAL

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

Drug: ABBV-157Drug: Placebo for ABBV-157

Substudy 1: Group 3

EXPERIMENTAL

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

Drug: ABBV-157Drug: Placebo for ABBV-157

Substudy 1: Group 2

EXPERIMENTAL

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

Drug: ABBV-157Drug: Placebo for ABBV-157

Substudy 1: Group 1

EXPERIMENTAL

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

Drug: ABBV-157Drug: Placebo for ABBV-157

Interventions

ABBV-157DRUG

ABBV-157 will be administered orally as capsule

Substudy 1: Group 1Substudy 1: Group 2Substudy 1: Group 3Substudy 2: Group 1Substudy 2: Group 2
Placebo for ABBV-157DRUG

Placebo for ABBV-157 will be administered orally as capsule

Substudy 1: Group 1Substudy 1: Group 2Substudy 1: Group 3Substudy 2: Group 1Substudy 2: Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Total Skin and Beauty Derm Ctr /ID# 222593

Birmingham, Alabama, 35205, United States

Location

Alliance Dermatology and MOHs /ID# 222622

Phoenix, Arizona, 85032, United States

Location

Anaheim Clinical Trials LLC /ID# 213645

Anaheim, California, 92801-2658, United States

Location

Dermatology Res. Assoc., CA /ID# 224980

Los Angeles, California, 90045, United States

Location

Providence Clinical Research /ID# 213339

North Hollywood, California, 91606, United States

Location

Advanced Medical Research /ID# 216090

Sandy Springs, Georgia, 30328-6141, United States

Location

Acpru /Id# 213639

Grayslake, Illinois, 60030, United States

Location

University of Pittsburgh MC /ID# 224699

Pittsburgh, Pennsylvania, 15260, United States

Location

PPD PH I Clinical Unit /ID# 213062

Austin, Texas, 78744, United States

Location

Center for Clinical Studies - Webster TX /ID# 217352

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 22, 2019

Study Start

June 11, 2019

Primary Completion

April 13, 2021

Study Completion

April 13, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(10)