Clinical trial NCT05083078: A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Arthritis, Psoriatic
Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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)

Primary outcomes:
measure: Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
timeFrame: Up to Week 12
measure: Part 1: Colon Tissue versus Serum Concentration Ratio
timeFrame: Up to Week 8
measure: Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
timeFrame: Up to Week 4
measure: Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
timeFrame: Up to Week 12
Secondary outcomes:
measure: Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: 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
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: Parts 1, 2 and 3: Terminal Half-life (T1/2)
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
measure: Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab
timeFrame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: