Clinical trials: Ustekinumab
Nonradiographic Axial Spondylitis, Ankylosing
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic…
- Trial name
- NCT02407223
- Testing
- Group 2: Ustekinumab 45 mg, Group 3: Ustekinumab 90 mg
- Where
- 90 sites in Argentina, Australia and 12 more
- Volunteers
- 356 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response…
- Trial name
- POWER (NCT03782376)
- Testing
- Ustekinumab approximately 6 mg/kg (IV), Ustekinumab 90 mg (SC) Group 1, Ustekinumab 90 mg (SC) Group 2
- Where
- 104 sites in United States, Austria and 10 more
- Volunteers
- 215 people
- Sponsor
- Janssen-Cilag Ltd.
Crohn's Disease
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if…
- Trial name
- NCT00771667
- Testing
- Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP), Ustekinumab 6 mg/kg (IP)
- Where
- 174 sites in United States, Australia and 10 more
- Volunteers
- 526 people
- Sponsor
- Centocor, Inc.
Lupus Erythematosus, Systemic
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in…
- Trial name
- NCT02349061
- Testing
- Ustekinumab IV, Ustekinumab SC, Concomitant Medication
- Where
- 43 sites in United States, Argentina and 7 more
- Volunteers
- 102 people
- Sponsor
- Janssen Research & Development, LLC
Takayasu Arteritis
A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
The purpose of this study is to evaluate the efficacy of ustekinumab compared to placebo, in combination with oral glucocorticoid (GC) taper regimen, in participants with relapsing Takayasu Arteritis (TAK).
- Trial name
- NCT04882072
- Testing
- Ustekinumab, Glucorticoid Taper Regimen
- Where
- 27 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
Arthritis, Juvenile
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
- Trial name
- PSUMMIT-Jr (NCT05083182)
- Testing
- Ustekinumab, Guselkumab
- Where
- 50 sites in United States, Argentina and 8 more
- Volunteers
- 48 people
- Sponsor
- Janssen Research & Development, LLC
Sarcoidosis
A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients).
- Trial name
- NCT00955279
- Testing
- Golimumab, Ustekinumab
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 173 people
- Sponsor
- Centocor, Inc.
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
Healthy
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects
This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced Stelara® and US sourced Stelara® in…
- Trial name
- NCT04772274
- Testing
- Ustekinumab
- Where
- France
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Polymyositis, Dermatomyositis
A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or…
- Trial name
- NCT03981744
- Testing
- Ustekinumab 6 mg/kg, Ustekinumab 90 mg
- Where
- 32 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
Psoriatic Arthritis
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment
- Trial name
- AgAIN (NCT04632927)
- Testing
- Secukinumab, Ustekinumab
- Where
- 28 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Novartis Pharmaceuticals
Arthritis, Rheumatoid, Spondyloarthritis, Axial
Biologic Treatment Registry Across Canada
This registry is a multi-center, prospective, longitudinal, observational program that will gather and analyse data on participants treated with infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab.
- Conditions
- Arthritis, Rheumatoid, Spondyloarthritis, Axial, Arthritis, Psoriatic
- Trial name
- BioTRAC (NCT00741793)
- Where
- Canada
- Volunteers
- 2,821 people
- Sponsor
- Janssen Inc.
Psoriasis
Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults
BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara® (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat people with Crohn's disease, Ulcerative…
- Trial name
- NCT04843631
- Testing
- BFI-751, EU-STELARA®, US-STELARA®
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- BioFactura Australia Pty Ltd.
Multiple Sclerosis
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis
- Trial name
- NCT00207727
- Testing
- CNTO 1275
- Volunteers
- 249 people
- Sponsor
- Centocor, Inc.
Axial Spondyloarthritis
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and…
- Trial name
- NCT02437162
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg, Golimumab 50 mg
- Where
- 57 sites in United States, Czechia and 5 more
- Volunteers
- 347 people
- Sponsor
- Janssen Research & Development, LLC
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
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
Chronic Plaque Type Psoriasis
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis
- Trial name
- NCT02074982
- Testing
- AIN457 300 mg, ustekinumab 45/90 mg
- Where
- 137 sites in United States, Australia and 22 more
- Volunteers
- 676 people
- Sponsor
- Novartis Pharmaceuticals