Clinical trials: Ustekinumab
Crohn Disease, Colitis, Ulcerative
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's…
- Trial name
- TENOR (NCT03606499)
- Testing
- Ustekinumab
- Where
- France
- Volunteers
- 111 people
- Sponsor
- Janssen Cilag S.A.S.
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
Psoriasis
A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
The purpose of this study is to assess the effectiveness and safety of guselkumab following a switch from ustekinumab or an ustekinumab biosimilar in participants with moderate to severe psoriasis, a chronic inflammatory skin…
- Trial name
- G-LINK (NCT07449234)
- Where
- Austria
- Volunteers
- 9 people
- Sponsor
- Janssen-Cilag Ltd.
Crohn Disease
A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease.
- Trial name
- NCT04978493
- Testing
- BI 706321, Ustekinumab
- Where
- 49 sites in United States, Belgium and 9 more
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Psoriasis
BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.
- Trial name
- NCT02054481
- Testing
- BI 655066, Ustekinumab
- Where
- 32 sites in United States, Canada and 5 more
- Volunteers
- 166 people
- Sponsor
- Boehringer Ingelheim
Psoriasis
An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis
The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.
- Trial name
- NCT00723528
- Testing
- Ustekinumab 45 mg (CP), Ustekinumab 90 mg (CP)
- Where
- 27 sites in Japan
- Volunteers
- 158 people
- Sponsor
- Janssen Pharmaceutical K.K.
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
- Trial name
- NCT03517722
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 mg
- Where
- 204 sites in United States, Argentina and 18 more
- Volunteers
- 516 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
- Trial name
- NCT01009086
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- 102 sites in United States, Australia and 12 more
- Volunteers
- 615 people
- Sponsor
- Janssen Research & Development, LLC
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
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
Plaque Psoriasis
A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries
The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.
- Trial name
- MARCOPOLO (NCT01677598)
- Testing
- No intervention
- Where
- 9 sites in Indonesia, Malaysia and 3 more
- Volunteers
- 169 people
- Sponsor
- Janssen Research & Development, LLC
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
Psoriatic Arthritis
A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis
The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to…
- Trial name
- PsaBio (NCT02627768)
- Testing
- No Intervention
- Where
- 66 sites in Belgium, France and 5 more
- Volunteers
- 991 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
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
Psoriasis
A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy.
- Trial name
- TRANSIT (NCT01059773)
- Testing
- Ustekinumab, Methotrexate
- Where
- 76 sites in Austria, Belgium and 17 more
- Volunteers
- 490 people
- Sponsor
- Janssen-Cilag International NV
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.
Axial Spondyloarthritis
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of…
- Trial name
- NCT02438787
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg, Golimumab 50 mg
- Where
- 148 sites in United States, Argentina and 17 more
- Volunteers
- 315 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis, Crohn's Disease
A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease
More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or…
- Trial name
- NCT07250815
- Testing
- No intervention
- Where
- United States
- Sponsor
- Takeda
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.