Clinical trials: Ustekinumab
Crohn Disease
Stelara and Diet Trial for Crohn"s Disease
Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing.
- Trial name
- NCT04779762
- Testing
- Crohn's disease exclusion diet (CDED), Ustekinumab Injection [Stelara]
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Wolfson Medical Center
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.
Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood.
- Trial name
- TDMpIBD (NCT06954311)
- Where
- 10 sites in Austria
- Volunteers
- 120 people
- Sponsor
- Medical University Innsbruck
Crohn's Disease
Clinical Efficacy of Ustekinumab in Crohn's Disease
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
- Trial name
- NCT06523647
- Where
- 4 sites in Kazakhstan
- Volunteers
- 150 people
- Sponsor
- Kazakhstan Scientific Society for Study of intestine diseases
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
Inflammatory Bowel Disease (IBD), Crohn Disease (CD)
Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab.
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
- Trial name
- SHIFT-IBD (NCT07245394)
- Testing
- Guselkumab (Tremfya)
- Where
- 14 sites in Canada
- Volunteers
- 200 people
- Sponsor
- TIDHI Innovation Inc.
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.
Ustekinumab Serum Levels in Patients With Crohn´s Disease
Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.
A prospective, non-commercial, multicenter study will be conducted in a cohort of patients initiating induction therapy and a cohort of patients with stable treatment with ustekinumab.
- Trial name
- USTECRO (NCT07100093)
- Testing
- Drug serum levels
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitario La Paz
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.
Type 1 Diabetes Mellitus
Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)
In type 1 diabetes (T1D), immune defense cells in the body attack and destroy insulin-producing beta cells leaving affected people with a lifelong need for daily insulin injections.
- Trial name
- UST1D2 (NCT03941132)
- Testing
- Ustekinumab
- Where
- 2 sites in Canada
- Volunteers
- 66 people
- Sponsor
- University of British Columbia