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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05083078
• Other study ID #: CR109047
• Secondary ID: 2021-000896-35CN
• Status: Terminated
• Phase: Phase 1
• Start date: November 4, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Healthy

Intervention

Drug:
• Guselkumab
Guselkumab will be administered subcutaneously.
• Risankizumab
Risankizumab will be administered subcutaneously.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Austria, 

Outcome

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