Clinical trials: Guselkumab
Hailey Hailey Disease
Efficacy of Guselkumab in Treating Hailey Hailey Disease
Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters.
- Trial name
- NCT06651489
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Yale University
Healthy Subjects
A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon
This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.
- Trial name
- NCT07788807
- Testing
- Adalimumab, Guselkumab, SDL-001
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Surmount Services, Inc.
Healthy
A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.
- Trial name
- NCT04147338
- Testing
- Guselkumab
- Where
- 2 sites in United States, Germany
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab…
- Trial name
- NCT04617691
- Testing
- Guselkumab
- Where
- Germany
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Psoriasis of Scalp
Immune Spatial Features of Guselkumab Cutaneous Response
This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.
- Trial name
- NCT05858632
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthy
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants
The purpose of this study is to assess the safety and tolerability of guselkumab following single-dose intravenous (IV) infusion in Japanese healthy male participants.
- Trial name
- NCT03536325
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Psoriasis Guttate, Plaque Psoriasis
Guselkumab Immunogenetics
This is a two-arm open-label study to evaluate the clinical and immunogenetic responses of patients with plaque or guttate psoriasis to treatment with guselkumab.
- Trial name
- TIG (NCT04645355)
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthy
A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants
The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.
- Trial name
- NCT02570373
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants; to evaluate the PK of ustekinumab following…
- Trial name
- NCT04030533
- Testing
- Guselkumab (SC): Dose 1, Guselkumab (SC): Dose 2, Guselkumab (IV): Dose 1
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations.
- Trial name
- NCT01866007
- Testing
- Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U), Guselkumab (liquid formulation with PFS FID)
- Where
- 3 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic, Healthy
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
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).
- Trial name
- NCT05083078
- Testing
- Guselkumab, Risankizumab
- Where
- Austria
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Psoriasis Vulgaris
An Explorative Psoriasis Biomarker Study
Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions.
- Trial name
- NCT04394936
- Testing
- Guselkumab
- Where
- Netherlands
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Centre for Human Drug Research, Netherlands