Clinical trials: Ustekinumab
Psoriasis
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects
It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male…
- Trial name
- NCT04371185
- Testing
- BAT2206, Stelara(US-licensed), Stelara(EU-licensed)
- Where
- China
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Bio-Thera Solutions
Healthy Volunteers
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg.
- Trial name
- NCT06481215
- Testing
- GNR-068, Stelara®
- Where
- 2 sites in Russia
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
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
Healthy Subjects
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU…
- Trial name
- NCT04428814
- Testing
- CT-P43, EU-approved Stelara, US-licensed Stelara
- Where
- 2 sites in New Zealand
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Celltrion
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
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Polymorphism, Single Nucleotide
The Association Between TNFSF4 Polymorphism and CD
The goal of this observational study is to investigate the associations between tumor necrosis factor superfamily member 4 (TNFSF4) gene polymorphisms and the risk of Crohn's disease (CD), and to elucidate the impact of TNFSF4…
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Polymorphism, Single Nucleotide, Ustekinumab
- Trial name
- NCT07263464
- Testing
- Ustekinumab - Standard Dosage
- Where
- China
- Volunteers
- 818 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
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.
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.
Healthy
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
- Trial name
- NCT04816513
- Testing
- Ustekinumab
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab)
Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and…
- Trial name
- NCT04744363
- Testing
- Stelara PFS
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Alzheimer Disease
Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO
This Observational protocol will attempt to verify two recent and very critical concepts in ALZ Clinical Research by studying high-risk individuals who already are taking medications which may prevent the onset of ALZ.
- Trial name
- PCD=OOALZ (NCT02835716)
- Testing
- roflumilast, ustekinumab
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Millennium Magnetic Technologies, LLC
Psoriasis With Cell-derived Microparticles
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic vascular diseases, including stroke, myocardial infarction, and impaired microcirculations, among which circulating microparticles play an…
- Trial name
- NCT02693470
- Testing
- Ustekinumab
- Where
- Taiwan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
IBD
Combination Therapy With Two Biologicals
The efficacy and safety of dual biological therapy.
- Trial name
- Combi (NCT05135221)
- Testing
- dual biological therapy
- Where
- Finland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital
Psoriasis
Study to Evaluate Broadlumab vs Placebo and Ustekinumab
The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to severe plaque psoriasis.
- Trial name
- AMAGINE-3 (NCT02786732)
- Testing
- 210mg Brodalumab, 140mg Brodalumab, Ustekinumab
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- MedDerm Associates
Moderate to Severe Chronic Plaque Psoriasis
This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab…
- Trial name
- NCT06738277
- Testing
- Bmab 1200 (Biosimilar Ustekinumab)
- Where
- India
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
Crohn's Disease, Ustekinumab
A Study on the Associations of Toll-like Receptor 5 Gene Polymorphisms With Crohn's Disease in Chinese Patients
The exact etiology and pathogenesis of Crohn's disease (CD) have not been fully elucidated, and may be related to the combined effects of genetics, environment, immunity, gut microbiota, and many other factors.
- Conditions
- Crohn's Disease, Ustekinumab, Toll-like Receptor 5, Polymorphism, Single Nucleotide
- Trial name
- NCT07035678
- Where
- China
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Healthy Volunteers
Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule
A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111").
- Trial name
- NCT05890118
- Testing
- Stelara, RT-111 (0.5mg), RT-111 (0.75mg)
- Where
- Australia
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- RANI Therapeutics
IBD
Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease
The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Molecular markers that can accurately predict the efficacy of UST are urgently needed to provide theoretical basis for…
- Trial name
- NCT06203158
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Psoriatic Arthritis
Changes in Body Composition Under Ustekinumab in PsA
There is not much body composition and bone mineral density data available for patients with psoriatic arthritis (rheumatoid arthritis) compared to control subjects.
- Trial name
- STELARA-CC (NCT03823924)
- Testing
- Bone mineral density (BMD)
- Where
- France
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille