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
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.
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
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
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
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
Palmoplantar Pustulosis
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.
- Trial name
- NCT02641730
- Testing
- Guselkumab
- Where
- 32 sites in Japan
- Volunteers
- 159 people
- Sponsor
- Janssen Pharmaceutical K.K.
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.
Arthritis, Psoriatic
A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants
This observational study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes…
- Trial name
- PEGASUS (NCT07532226)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Janssen-Cilag Ltd.
Psoriasis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
- Trial name
- PROTOSTAR (NCT03451851)
- Testing
- Guselkumab, Etanercept
- Where
- 39 sites in United States, Australia and 7 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative, Crohn Disease
A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting.
- Trial name
- GALILEO (NCT07848737)
- Volunteers
- 200 people
- Sponsor
- Janssen-Cilag, S.A.
Psoriasis
A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
The purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis.
- Trial name
- GULLIVER (NCT04439526)
- Testing
- Guselkumab
- Where
- 38 sites in Italy
- Volunteers
- 356 people
- Sponsor
- Janssen-Cilag S.p.A.