A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Healthy Participants-Coadministration Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. |
Drug: Guselkumab
Guselkumab will be administered subcutaneously.
Other Names:
Drug: Risankizumab
Risankizumab will be administered subcutaneously.
Other Names:
|
| Experimental: Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. |
Drug: Guselkumab
Guselkumab will be administered subcutaneously.
Other Names:
Drug: Risankizumab
Risankizumab will be administered subcutaneously.
Other Names:
|
| Experimental: Part 3: PsA Participants-Separate Administration Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29. |
Drug: Guselkumab
Guselkumab will be administered subcutaneously.
Other Names:
Drug: Risankizumab
Risankizumab will be administered subcutaneously.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio [Up to Week 12]
Skin 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.
- Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio [Up to Week 4]
Colon tissue versus serum concentration ratio will be summarized.
- Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio [Up to Week 12]
Synovial tissue versus serum concentration ratio will be summarized.
Secondary Outcome Measures
- 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: 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: 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: 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: 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: 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.
Eligibility Criteria
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/m2) to 30 kg/m2 (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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University Graz | Graz | Austria | 8010 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109047
- 2021-000896-35
- CNTO1959PSA1001