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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000896-35 | EudraCT Number | ||
| CNTO1959PSA1001 | Other Identifier | Janssen Research & Development, LLC |
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The study was stopped due to unanticipated feasibility constraints.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Healthy Participants-Coadministration | Experimental | Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. |
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| Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration | Experimental | Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. |
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| Part 3: PsA Participants-Separate Administration | Experimental | Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered subcutaneously. |
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| 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 |
| 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 |
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Inclusion Criteria:
Part 1:
Parts 2 and 3:
Exclusion Criteria:
Part 1:
Parts 2 and 3:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | 8010 | Austria |
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
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
| C000601773 | risankizumab |
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| Risankizumab | Drug | Risankizumab will be administered subcutaneously. |
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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 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |