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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
ABBV-157 will be administered orally as capsule
Placebo for ABBV-157 will be administered orally as capsule
Total Skin and Beauty Derm Ctr /ID# 222593
Birmingham, Alabama, United States
Alliance Dermatology and MOHs /ID# 222622
Phoenix, Arizona, United States
Anaheim Clinical Trials LLC /ID# 213645
Anaheim, California, United States
Dermatology Res. Assoc., CA /ID# 224980
Los Angeles, California, United States
Providence Clinical Research /ID# 213339
North Hollywood, California, United States
Advanced Medical Research /ID# 216090
Sandy Springs, Georgia, United States
Acpru /Id# 213639
Grayslake, Illinois, United States
University of Pittsburgh MC /ID# 224699
Pittsburgh, Pennsylvania, United States
PPD PH I Clinical Unit /ID# 213062
Austin, Texas, United States
Center for Clinical Studies - Webster TX /ID# 217352
Webster, Texas, United States
Substudy 1: Cmax of ABBV-157
Maximum observed plasma concentration (Cmax) of ABBV-157
Time frame: Up to approximately 14 days
Substudy 1: Tmax of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Time frame: 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.
Time frame: Day 1
Substudy 1: Trough Concentration (Ctrough) of ABBV-157
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Time frame: 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).
Time frame: 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.
Time frame: Day 14
Substudy 1: Volume of Distribution (Vβ/F)
Volume of Distribution (Vβ/F) of ABBV-157
Time frame: Day 14
Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Apparent Terminal phase elimination rate constant (β or Beta)
Time frame: Day 14
Substudy 1: Elimination Half-Life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-157
Time frame: Day 14
Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Fraction excreted unchanged in urine (fe)
Time frame: Day 14
Substudy 1: Apparent Renal Clearance (CLR)
Apparent Renal Clearance (CLR) of ABBV-157
Time frame: Day 14
Substudy 1: Accumulation ratio for Cmax
Accumulation ratio for Cmax
Time frame: Up to approximately 14 days
Substudy 1: Accumulation Ratio for AUCtau
Accumulation Ratio for AUCtau
Time frame: Up to approximately 14 days
Substudy 2: Cmax of ABBV-157
Maximum observed plasma concentration (Cmax) of ABBV-157
Time frame: Up to approximately 28 days
Substudy 2: Tmax of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Time frame: 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.
Time frame: Day 1
Substudy 2: AUCtau of ABBV-157
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Time frame: Day 28
Substudy 2: Apparent Oral Clearance (CL/F)
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Time frame: Day 28
Substudy 2: Volume of Distribution (Vβ/F)
Volume of Distribution (Vβ/F) of ABBV-157
Time frame: Day 28
Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Apparent Terminal phase elimination rate constant (β or Beta)
Time frame: Day 28
Substudy 2: Elimination Half-Life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-157
Time frame: Day 28
Substudy 2: Accumulation ratio for Cmax
Accumulation ratio for Cmax
Time frame: Up to approximately 28 days
Substudy 2: Accumulation Ratio for AUCtau
Accumulation Ratio for AUCtau
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 58
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