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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Healthy; Arthritis, Psoriatic

Treatments: Drug: Guselkumab; Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05083078

CR109047

2021-000896-35 (EudraCT Number)

CNTO1959PSA1001 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Part 1: Healthy Participants-Coadministration

Experimental group

Description:

Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.

Treatment:

Drug: Risankizumab

Drug: Guselkumab

Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration

Experimental group

Description:

Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29.

Treatment:

Drug: Risankizumab

Drug: Guselkumab

Part 3: PsA Participants-Separate Administration

Experimental group

Description:

Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29.

Treatment:

Drug: Risankizumab

Drug: Guselkumab