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

A Phase 1 Study to Assess the Relative PK and Tissue Distribution of Guselkumab and Risankizumab in Healthy Participants and Patients With Psoriatic Arthritis

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).

Study Overview

• Status: Terminated
• Conditions: Healthy; Arthritis, Psoriatic
• Intervention / Treatment: Drug: Guselkumab; Drug: Risankizumab

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medical University Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: Tremfya; CNTO1959; Drug: Risankizumab; Risankizumab will be administered subcutaneously.; Other Names: Skyrizi
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: Tremfya; CNTO1959; Drug: Risankizumab; Risankizumab will be administered subcutaneously.; Other Names: Skyrizi
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: Tremfya; CNTO1959; Drug: Risankizumab; Risankizumab will be administered subcutaneously.; Other Names: Skyrizi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio	Skin tissue versus serum concentration ratio will be summarized.	Up to Week 12
Part 1: Colon Tissue versus Serum Concentration Ratio	Colon tissue versus serum concentration ratio will be summarized.	Up to Week 8
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio	Colon tissue versus serum concentration ratio will be summarized.	Up to Week 4
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio	Synovial tissue versus serum concentration ratio will be summarized.	Up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab	Cmax is defined as maximum observed serum concentration.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab	Tmax is defined as time to reach maximum observed serum concentration.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
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	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.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab	AUC(0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity with extrapolation of the terminal phase.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Terminal Half-life (T1/2)	T1/2 is defined as terminal half-life.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab	CL/F is defined as apparent total systemic clearance after extravascular administration.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab	Vz/F is defined as apparent volume of distribution based on terminal phase after extravascular administration.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab	The detection and characterization of antibodies to guselkumab and risankizumab will be performed using a validated assay method.	Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: CR109047; 2021-000896-35 (EudraCT Number); CNTO1959PSA1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes