Back to resultsA Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
Primary Purpose
Arthritis, Psoriatic, Healthy
Status
Terminated
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Guselkumab
Risankizumab
Sponsored by
About this trial
This is an interventional basic science trial for Arthritis, Psoriatic
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)
Sites / Locations
- Medical University Graz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Part 1: Healthy Participants-Coadministration
Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration
Part 3: PsA Participants-Separate Administration
Arm Description
Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.
Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29.
Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29.
Outcomes
Primary Outcome Measures
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
Skin tissue versus serum concentration ratio will be summarized.
Part 1: Colon Tissue versus Serum Concentration Ratio
Colon tissue versus serum concentration ratio will be summarized.
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
Colon tissue versus serum concentration ratio will be summarized.
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
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
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
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
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
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)
T1/2 is defined as terminal half-life.
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.
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.
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.
Full Information
NCT ID
NCT05083078
First Posted
October 11, 2021
Last Updated
July 22, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05083078
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to unanticipated feasibility constraints.
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Healthy Participants-Coadministration
Arm Type
Experimental
Arm Description
Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.
Arm Title
Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration
Arm Type
Experimental
Arm Description
Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29.
Arm Title
Part 3: PsA Participants-Separate Administration
Arm Type
Experimental
Arm Description
Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
Tremfya, CNTO1959
Intervention Description
Guselkumab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
Skyrizi
Intervention Description
Risankizumab will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
Description
Skin tissue versus serum concentration ratio will be summarized.
Time Frame
Up to Week 12
Title
Part 1: Colon Tissue versus Serum Concentration Ratio
Description
Colon tissue versus serum concentration ratio will be summarized.
Time Frame
Up to Week 8
Title
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
Description
Colon tissue versus serum concentration ratio will be summarized.
Time Frame
Up to Week 4
Title
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
Description
Synovial tissue versus serum concentration ratio will be summarized.
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab
Description
Cmax is defined as maximum observed serum concentration.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab
Description
Tmax is defined as time to reach maximum observed serum concentration.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
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
Description
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.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab
Description
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity with extrapolation of the terminal phase.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
Parts 1, 2 and 3: Terminal Half-life (T1/2)
Description
T1/2 is defined as terminal half-life.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab
Description
CL/F is defined as apparent total systemic clearance after extravascular administration.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab
Description
Vz/F is defined as apparent volume of distribution based on terminal phase after extravascular administration.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Title
Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab
Description
The detection and characterization of antibodies to guselkumab and risankizumab will be performed using a validated assay method.
Time Frame
Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
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