A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
- Conditions
- HealthyArthritis, Psoriatic
- Interventions
- Registration Number
- NCT05083078
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Healthy Participants-Coadministration Guselkumab Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration Guselkumab Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. Part 3: PsA Participants-Separate Administration Guselkumab Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29. Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration Risankizumab Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. Part 1: Healthy Participants-Coadministration Risankizumab Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. Part 3: PsA Participants-Separate Administration Risankizumab Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29.
- Primary Outcome Measures
Name Time Method Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio Up to Week 12 Synovial tissue versus serum concentration ratio will be summarized.
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio Up to Week 12 Skin tissue versus serum concentration ratio will be summarized.
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio Up to Week 4 Colon tissue versus serum concentration ratio will be summarized.
Part 1: Colon Tissue versus Serum Concentration Ratio Up to Week 8 Colon tissue versus serum concentration ratio will be summarized.
- Secondary Outcome Measures
Name Time Method Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 AUC(0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity with extrapolation of the terminal phase.
Parts 1, 2 and 3: Terminal Half-life (T1/2) Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 T1/2 is defined as terminal half-life.
Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 Tmax is defined as time to reach maximum observed serum concentration.
Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 Cmax is defined as maximum observed serum concentration.
Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 CL/F is defined as apparent total systemic clearance after extravascular administration.
Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 Vz/F is defined as apparent volume of distribution based on terminal phase after extravascular administration.
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 Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 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.
Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24 The detection and characterization of antibodies to guselkumab and risankizumab will be performed using a validated assay method.
Trial Locations
- Locations (1)
Medical University Graz
🇦🇹Graz, Austria