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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05083078
Phase
PHASE1
Status
Terminated

Conditions

  • Arthritis, Psoriatic
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered subcutaneously.
  • Risankizumab — DRUG
    Risankizumab will be administered subcutaneously.

Study Details

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).

Key Dates

Start date
Nov 4, 2021
Status verified
Jul 2022
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1: Healthy Participants-Coadministration
    Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.
  • 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.
  • 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.

Primary Outcome Measure

Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio [ Time Frame: Up to Week 12 ]

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