Clinical trials: Ustekinumab
Crohn Disease
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure…
- Trial name
- UNITI Jr (NCT04673357)
- Testing
- Ustekinumab
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 101 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis.
- Trial name
- EMBRACE 1 (NCT04305327)
- Testing
- Brodalumab, Ustekinumab
- Where
- 35 sites in Belgium, France and 6 more
- Volunteers
- 12 people
- Sponsor
- LEO Pharma
Plaque Psoriasis
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.
- Trial name
- AMAGINE-3 (NCT01708629)
- Testing
- 210 mg brodalumab, 140 mg brodalumab, ustekinumab
- Where
- 157 sites in United States, Australia and 9 more
- Volunteers
- 1,881 people
- Sponsor
- Bausch Health Americas, Inc.
Arthritis, Rheumatoid
A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy
The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and…
- Trial name
- NCT01645280
- Testing
- Ustekinumab + MTX (Group 2), Ustekinumab + MTX (Group 3), CNTO 1959 + MTX (Group 4)
- Where
- 47 sites in United States, Argentina and 9 more
- Volunteers
- 274 people
- Sponsor
- Janssen Research & Development, LLC
Psoriatic Arthritis
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).
- Trial name
- NCT02319759
- Testing
- Guselkumab, Ustekinumab
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 149 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
- Trial name
- NCT01077362
- Testing
- ustekinumab 45 mg, ustekinumab 90 mg
- Where
- 80 sites in United States, Austria and 8 more
- Volunteers
- 312 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.
- Trial name
- NCT01090427
- Testing
- Ustekinumab - Half-Standard Dosage, Ustekinumab - Standard Dosage
- Where
- 50 sites in Belgium, Canada and 8 more
- Volunteers
- 110 people
- Sponsor
- Janssen Research & Development, LLC
Moderate to Severe Plaque Psoriasis
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe…
- Trial name
- BE TOGETHER (NCT06425549)
- Testing
- bimekizumab, ustekinumab
- Where
- 42 sites in United States, Belgium and 8 more
- Volunteers
- 176 people
- Sponsor
- UCB Biopharma SRL
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
Crohn Disease, Ulcerative Colitis
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe…
- Trial name
- NCT03358706
- Testing
- Ustekinumab IV Infusion, Ustekinumab SC Injection, Midazolam 2 mg
- Where
- 16 sites in United States, Belgium and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Moderate to Severe Chronic Plaque Psoriasis
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
- Trial name
- Opportuniti (NCT04785326)
- Testing
- DMB-3115, Stelara
- Where
- 2 sites in United States
- Volunteers
- 598 people
- Sponsor
- Dong-A ST Co., Ltd.
Moderate to Severe Plaque Psoriasis
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
- Trial name
- AMAGINE-2 (NCT01708603)
- Testing
- 210 mg brodalumab, 140 mg brodalumab, ustekinumab
- Where
- 153 sites in United States, Australia and 9 more
- Volunteers
- 1,831 people
- Sponsor
- Bausch Health Americas, Inc.
Dermatitis, Atopic
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.
- Trial name
- NCT01945086
- Testing
- Ustekinumab, Concomitant topical medications for atopic dermatitis
- Where
- 13 sites in Japan
- Volunteers
- 79 people
- Sponsor
- Janssen Pharmaceutical K.K.
Crohn Disease, Colitis, Ulcerative
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult…
- Trial name
- NCT04372108
- Testing
- Ustekinumab, Other Biologic Therapies
- Where
- United States
- Volunteers
- 1,536 people
- Sponsor
- Janssen Scientific Affairs, LLC
Crohn Disease, Plaque Psoriasis
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided…
- Trial name
- ROLL'YN-UST (NCT06997055)
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- France
- Volunteers
- 225 people
- Sponsor
- Celltrion HealthCare France
Plaque Psoriasis
An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis
This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms…
- Trial name
- NCT06488664
- Testing
- GNR-068, Stelara®
- Where
- 34 sites in Russia
- Volunteers
- 422 people
- Sponsor
- AO GENERIUM
Psoriasis
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to…
- Trial name
- NAVIGATE (NCT02203032)
- Testing
- Ustekinumab, Guselkumab
- Where
- 85 sites in United States, Australia and 8 more
- Volunteers
- 872 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease
The purpose of this program is to provide early access to ustekinumab where it is commercially unavailable for the treatment of participants with moderately to severely active Crohn's disease who have failed treatment with…
- Trial name
- NCT03362736
- Testing
- Ustekinumab
- Where
- 6 sites in Brazil
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a…
- Trial name
- NCT02156375
- Testing
- Ustekinumab
- Where
- 3 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
- Trial name
- ICONIC-ASCEND (NCT06934226)
- Testing
- JNJ-77242113, Ustekinumab
- Where
- 160 sites in United States, Argentina and 11 more
- Volunteers
- 752 people
- Sponsor
- Janssen Research & Development, LLC