Clinical trials: Ustekinumab
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis, Cardiovascular Disease
Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)
The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis.
- Trial name
- VIP-U (NCT02187172)
- Testing
- Ustekinumab
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Pennsylvania
Behcet's Syndrome, Intestinal Type, Myelodysplastic Syndrome
Ustekinumab for Intestinal Behçet's Syndrome With Myelodysplastic Syndrome
Behçet's syndrome is a systemic vasculitis. Gastrointestinal involvement in Behçet's syndrome complicated by myelodysplastic syndrome represents a rare and severe subtype for which no standardized treatment guidelines currently…
- Trial name
- NCT07582991
- Testing
- Ustekinumab 90 mg
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Liu Tian
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
Behçet Disease
Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease
The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis…
- Trial name
- STELABEC (NCT02648581)
- Testing
- Subcutaneous Ustekinumab
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
Crohn Disease, Colitis, Ulcerative
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult…
- Trial name
- NCT04372108
- Testing
- Ustekinumab, Other Biologic Therapies
- Where
- United States
- Volunteers
- 1,536 people
- Sponsor
- Janssen Scientific Affairs, LLC
Crohn Disease
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
The goal of this clinical trial is to evaluate the efficacy and safety of dual-target therapy (Ustekinumab combined with Upadacitinib) versus intensified Ustekinumab monotherapy in patients with Crohn's disease who have an…
- Trial name
- NCT06520397
- Testing
- Ustekinumab and Upadacitinib, Ustekinumab
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
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
Hematologic and Lymphocytic Disorder, Hematopoietic and Lymphoid System Neoplasm
Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant
This phase II trial studies how well ustekinumab works in preventing acute graft-versus-host disease after unrelated donor hematopoietic cell transplant.
- Trial name
- NCT04572815
- Testing
- Quality-of-Life Assessment, Questionnaire Administration, Ustekinumab
- Where
- 4 sites in United States
- Volunteers
- 116 people
- Sponsor
- Fred Hutchinson Cancer Center
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.
- Trial name
- NCT04060888
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 milligram (mg)
- 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
Uveitis
Ustekinumab for Active Sight-Threatening Uveitis
Background: Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops, drugs and sometimes surgery. In some people, treatment may not prevent vision loss.
- Trial name
- NCT01647152
- Testing
- Ustekinumab
- Sponsor
- National Eye Institute (NEI)
Palmo-Plantar Pustular Psoriasis, Palmo-Plantar Pustulosis
Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)
- Trial name
- NCT01091051
- Testing
- Ustekinumab
- Where
- 8 sites in Canada
- Volunteers
- 33 people
- Sponsor
- Innovaderm Research Inc.
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
Crohn Disease (CD), Ulcerative Colitis (UC)
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
- Trial name
- NCT07303686
- Testing
- Ustekinumab 90 mg SC q8w, Ustekinumab 90 mg SC q12w
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Primary Sjögren Syndrome
Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
This pilot study will make a preliminary determination of the safety of ustekinumab in patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures of inflammation (biomarkers).
- Trial name
- NCT04093531
- Testing
- Ustekinumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Rochester
Patients With Newly Diagnosed Active NISU
A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)
Uveitis is characterized by inflammation of the uvea, which is the middle portion of the eye. The greatest challenge for the treatment of uveitis is patients who have inflammation involving the posterior segment, either primarily…
- Trial name
- USTEKINISU (NCT03847272)
- Testing
- prednisone and ustekinumab treatment, Ophthalmologic examination, Questionnaires
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
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.