Clinical trials: Guselkumab
Plaque Psoriasis
A Phase 3 Clinical Study of QL2106 Injection
It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis.
- Trial name
- NCT07511647
- Testing
- QL2106 injection, Tremfya®
- Where
- China
- Volunteers
- 318 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Crohn's Disease (CD)
An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a…
- Trial name
- POST-CD (NCT07528040)
- Testing
- Guselkumab
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Shanghai 10th People's Hospital
Crohn's Disease
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan…
- Trial name
- REASON (NCT06408935)
- Testing
- Guselkumab
- Where
- 84 sites in United States, Australia and 12 more
- Volunteers
- 120 people
- Sponsor
- Janssen-Cilag Ltd.
Psoriasis, Pregnancy
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Conditions
- Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease
- Trial name
- NCT02103361
- Testing
- Ustekinumab, Guselkumab
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Diego
Lupus Nephritis
A Study of Guselkumab in Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
- Trial name
- ORCHID-LN (NCT04376827)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Standard-of-care treatment
- Where
- 60 sites in United States, Argentina and 7 more
- Volunteers
- 33 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis Arthritis
Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.
Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis.
- Trial name
- GUPAIN (NCT06974474)
- Testing
- Guselkumab
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
Psoriasis
Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis
The purpose of this study is to evaluate the potential effects of a single dose of 200 milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe substrates of Cytochrome P450 isozymes (CYP3A4…
- Trial name
- NCT02397382
- Testing
- Guselkumab, Midazolam, Warfarin
- Where
- 8 sites in United States
- Volunteers
- 16 people
- 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
Colitis, Ulcerative
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial…
- Trial name
- DUET-UC (NCT05242484)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 403 sites in United States, Argentina and 35 more
- Volunteers
- 577 people
- 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
Psoriasis
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.
- Trial name
- G-PLUS (NCT03998683)
- Testing
- Guselkumab 100 mg
- Where
- 26 sites in France, Germany and 3 more
- Volunteers
- 117 people
- Sponsor
- Janssen-Cilag Ltd.
Crohn Disease
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
- Trial name
- GRAVITI (NCT05197049)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 345 sites in United States, Australia and 25 more
- Volunteers
- 350 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- APEX (NCT04882098)
- Testing
- Guselkumab
- Where
- 280 sites in United States, Australia and 27 more
- Volunteers
- 1,054 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the…
- Trial name
- CHARGE (NCT07499232)
- Testing
- Guselkumab, Risankizumab
- Where
- 161 sites in United States, Austria and 15 more
- Volunteers
- 530 people
- Sponsor
- Janssen Research & Development, LLC
Crohns Disease
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
- Trial name
- NCT04397263
- Testing
- Guselkumab
- Where
- 25 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Janssen Pharmaceutical K.K.
Psoriasis (PsO), PsA (Psoriatic Arthritis)
Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy
The goal of this research study is to better understand if there is an association between non-alcoholic fatty liver disease (NAFLD) and active psoriatic disease (PD), and to assess the effect of Guselkumab (a medication approved…
- Conditions
- Psoriasis (PsO), PsA (Psoriatic Arthritis), NAFLD (Nonalcoholic Fatty Liver Disease)
- Trial name
- EMERGE (NCT07255781)
- Testing
- Guselkumab Prefilled Syringe [Tremfya]
- Sponsor
- University of California, San Diego
Crohn's Disease, Guselkumab
IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
Crohn's disease (CD) is a chronic non-specific intestinal inflammatory disease with incompletely clarified etiology, which can involve multiple organs and systems , and is prone to severe complications such as intestinal…
- Conditions
- Crohn's Disease, Guselkumab, Intestinal Ultrasound, Predictor
- Trial name
- NCT07034664
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The Third Xiangya Hospital of Central South University
Psoriasis
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type…
- Trial name
- POLARIS (NCT02951533)
- Testing
- Guselkumab, Fumaric Acid Esters
- Where
- 28 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Janssen-Cilag G.m.b.H
Crohn Disease, Colitis, Ulcerative
A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD)…
- Trial name
- G-FORCE (NCT07606339)
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Janssen-Cilag Pharma GmbH
Psoriasis
A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in the treatment of Chinese participants with moderate to severe plaque psoriasis.
- Trial name
- NCT04914429
- Testing
- Guselkumab
- Where
- 26 sites in China
- Volunteers
- 327 people
- Sponsor
- Janssen Research & Development, LLC