Overview

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

Status:
Not yet recruiting
Trial end date:
2023-05-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
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)

Part 2:

- 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

Part 2:

- 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)