Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||50 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Janssen Research & Development, LLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Janssen Research & Development, LLC Clinical Trial|
|Principal Investigator Affiliation||Janssen Research & Development, LLC|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Canada, France, Germany, Israel, Italy, Poland, Spain, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Giant Cell Arteritis|
|Study Website:||View Trial Website|
Giant cell arteritis (GCA) is a non-necrotizing granulomatous systemic vasculitis of unknown etiology affecting medium-sized and large arteries usually accompanied or preceded by systemic inflammation. Guselkumab is a monoclonal antibody (mAb) that binds to the p19 sub-unit of human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. The study consists of a screening period (less than or equal to (<=) 6 weeks), double-blind treatment period (48 weeks), and safety follow-up period (12 weeks). This study will evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of intravenous (IV) and subcutaneous (SC) administered guselkumab in combination with a 26-week GC taper regimen for the treatment of active new-onset or relapsing GCA in adult participants. The total duration of the study is up to 66 weeks.
Participants will receive guselkumab dose 1 intravenously (IV) at week 0, 4, and 8 and guselkumab dose 2 subcutaneously (SC) every 4 weeks (q4w) from week 12 through week 48. This will be in combination with a protocol specified 26-week GC taper.
Participants will receive matching placebo IV at week 0, 4 and 8 and matching placebo SC q4 weeks from week 12 through week 48. This will be in combination with a protocol-specified 26-week GC taper.
Drug: - Guselkumab
Guselkumab Dose 1 and Dose 2 will be administered IV and SC.
Drug: - Placebo
Matching placebo will be administered IV and SC.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.