Clinical trials: Ustekinumab
Psoriasis, Moderate to Severe Plaque Psoriasis
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.
- Trial name
- NCT04967508
- Testing
- Stelara® (Ustekinumab), SB17 (Proposed Ustekinumab Biosimilar)
- Where
- 32 sites in Czechia, Estonia and 6 more
- Volunteers
- 503 people
- 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.
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's Disease (CD)
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab.
- Trial name
- SEQUENCE (NCT04524611)
- Testing
- Risankizumab, Ustekinumab
- Where
- 300 sites in United States, Argentina and 29 more
- Volunteers
- 527 people
- Sponsor
- AbbVie
Psoriatic Arthritis
A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab
The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.
- Trial name
- PROUST (NCT03336281)
- Testing
- Ustekinumab
- Where
- France
- Volunteers
- 221 people
- Sponsor
- Janssen Cilag S.A.S.
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.
Psoriasis
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin.
- Trial name
- OptIMMize-1 (NCT04435600)
- Testing
- Risankizumab, Ustekinumab
- Where
- 53 sites in United States, Canada and 5 more
- Volunteers
- 139 people
- Sponsor
- AbbVie
Chronic Plaque-type Psoriasis
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab
The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab as compared with the selective inhibition of IL-23 with guselkumab (p19 subunit blocker) in controlling inflammation in psoriatic…
- Trial name
- ARROW (NCT03553823)
- Testing
- Skin biopsies
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis
The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.
- Trial name
- NCT00454584
- Testing
- CNTO 1275 45 mg, CNTO 1275 90 mg, Etanercept 50 mg
- Volunteers
- 903 people
- Sponsor
- Centocor, Inc.
Psoriatic Arthritis
An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.
- Trial name
- NCT00267956
- Testing
- CNTO 1275 63 mg
- Where
- 25 sites in United States, Canada and 3 more
- Volunteers
- 146 people
- Sponsor
- Centocor, Inc.
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.
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
Crohn's Disease, IBD
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or…
- Conditions
- Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease
- Trial name
- NCT01369329
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 175 sites in United States, Australia and 21 more
- Volunteers
- 769 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice
The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting.
- Trial name
- G-START (NCT07746583)
- Where
- Hungary
- Volunteers
- 100 people
- Sponsor
- Janssen-Cilag Kft.
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)
This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the acquisition, handling and shipping procedure for skin biopsies obtained from participants with plaque psoriasis.
- Trial name
- NCT01276847
- Testing
- Ustekinumab, Etanercept
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn Disease
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.
- Trial name
- STARDUST (NCT03107793)
- Testing
- Ustekinumab
- Where
- 107 sites in Belgium, Czechia and 10 more
- Volunteers
- 500 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.
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
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.