A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
NCT ID: NCT05083078
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
11 participants
INTERVENTIONAL
2021-11-04
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
NCT04882098
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
NCT04936308
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
NCT03162796
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
NCT02319759
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
NCT05071664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: Healthy Participants-Coadministration
Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.
Guselkumab
Guselkumab will be administered subcutaneously.
Risankizumab
Risankizumab will be administered subcutaneously.
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.
Guselkumab
Guselkumab will be administered subcutaneously.
Risankizumab
Risankizumab will be administered subcutaneously.
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.
Guselkumab
Guselkumab will be administered subcutaneously.
Risankizumab
Risankizumab will be administered subcutaneously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Guselkumab
Guselkumab will be administered subcutaneously.
Risankizumab
Risankizumab will be administered subcutaneously.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Graz
Graz, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-000896-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNTO1959PSA1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR109047
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.