A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).

Official Title
-----------------
A Phase 1 Study to Assess the Relative PK and Tissue Distribution of Guselkumab and Risankizumab in Healthy Participants and Patients With Psoriatic Arthritis

Conditions
-----------------
Arthritis, Psoriatic, Healthy

Intervention / Treatment
-----------------
* Drug: Guselkumab
* Drug: Risankizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part 1: Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive) Parts 2 and 3: Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening Have active plaque psoriasis Exclusion Criteria: Part 1: History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration Parts 2 and 3: History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Healthy Participants-Coadministration<br>Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO1959;Drug: Risankizumab<br>* Risankizumab will be administered subcutaneously.<br>* Other names: Skyrizi;|
| Experimental: Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration<br>Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO1959;Drug: Risankizumab<br>* Risankizumab will be administered subcutaneously.<br>* Other names: Skyrizi;|
| Experimental: Part 3: PsA Participants-Separate Administration<br>Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO1959;Drug: Risankizumab<br>* Risankizumab will be administered subcutaneously.<br>* Other names: Skyrizi;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio | Skin tissue versus serum concentration ratio will be summarized. | Up to Week 12 | 
| Part 1: Colon Tissue versus Serum Concentration Ratio | Colon tissue versus serum concentration ratio will be summarized. | Up to Week 8 | 
| Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio | Colon tissue versus serum concentration ratio will be summarized. | Up to Week 4 | 
| Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio | Synovial tissue versus serum concentration ratio will be summarized. | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab | Cmax is defined as maximum observed serum concentration. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab | Tmax is defined as time to reach maximum observed serum concentration. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of Guselkumab and Risankizumab | AUC(0-last) is defined as area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity with extrapolation of the terminal phase. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Terminal Half-life (T1/2) | T1/2 is defined as terminal half-life. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab | CL/F is defined as apparent total systemic clearance after extravascular administration. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab | Vz/F is defined as apparent volume of distribution based on terminal phase after extravascular administration. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 | 
| Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab | The detection and characterization of antibodies to guselkumab and risankizumab will be performed using a validated assay method. | Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 |