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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: ABBV-157
* Drug: Placebo for ABBV-157


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Substudy 2: Group 2<br>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<br>* ABBV-157 will be administered orally as capsule<br>Drug: Placebo for ABBV-157<br>* Placebo for ABBV-157 will be administered orally as capsule<br>|
| Experimental: Substudy 2: Group 1<br>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<br>* ABBV-157 will be administered orally as capsule<br>Drug: Placebo for ABBV-157<br>* Placebo for ABBV-157 will be administered orally as capsule<br>|
| Experimental: Substudy 1: Group 3<br>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<br>* ABBV-157 will be administered orally as capsule<br>Drug: Placebo for ABBV-157<br>* Placebo for ABBV-157 will be administered orally as capsule<br>|
| Experimental: Substudy 1: Group 2<br>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<br>* ABBV-157 will be administered orally as capsule<br>Drug: Placebo for ABBV-157<br>* Placebo for ABBV-157 will be administered orally as capsule<br>|
| Experimental: Substudy 1: Group 1<br>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<br>* ABBV-157 will be administered orally as capsule<br>Drug: Placebo for ABBV-157<br>* Placebo for ABBV-157 will be administered orally as capsule<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Chronic Plaque Psoriasis, ABBV-157, Healthy Volunteers