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

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: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: ABBV-157; Drug: Placebo for ABBV-157

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): April 13, 2021
• Study Completion (Actual): April 13, 2021

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Psoriasis; Healthy Volunteers; Chronic Plaque Psoriasis; ABBV-157
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID 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