Clinical trials: Ustekinumab
Colitis, Ulcerative, Inflammatory Bowel Diseases
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as…
- Trial name
- UNIFI (NCT02407236)
- Testing
- Ustekinumab IV, Ustekinumab SC
- Where
- 247 sites in United States, Australia and 21 more
- Volunteers
- 961 people
- Sponsor
- Janssen Research & Development, LLC
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.
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
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate…
- Trial name
- STELLAR-2 (NCT05335356)
- Testing
- Stelara, Bmab1200
- Where
- United States
- Volunteers
- 384 people
- Sponsor
- Biocon Biologics UK Ltd
Psoriasis
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.
- Trial name
- NCT04673786
- Testing
- CT-P43, Stelara
- Where
- Estonia
- Volunteers
- 509 people
- Sponsor
- Celltrion
Plaque Psoriasis
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.
- Trial name
- CLARITY (NCT02826603)
- Testing
- Secukinumab, Ustekinumab
- Where
- 154 sites in United States, Canada and 9 more
- Volunteers
- 1,114 people
- Sponsor
- Novartis Pharmaceuticals
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.
Crohn Disease (CD)
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice…
- Trial name
- NCT07077681
- Where
- 11 sites in France
- Volunteers
- 246 people
- Sponsor
- EG Labo
Psoriasis
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
- Trial name
- NCT02684370
- Testing
- risankizumab, ustekinumab
- Volunteers
- 560 people
- Sponsor
- AbbVie
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.
Plaque Psoriasis
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
- Trial name
- ICONIC-ASCEND (NCT06934226)
- Testing
- JNJ-77242113, Ustekinumab
- Where
- 160 sites in United States, Argentina and 11 more
- Volunteers
- 752 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease, Colitis
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to…
- Conditions
- Crohn's Disease, Colitis, IBD, Inflammatory Bowel Disease
- Trial name
- NCT01369355
- Testing
- Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV, Ustekinumab 90 mg SC q12w
- Where
- 220 sites in United States, Australia and 24 more
- Volunteers
- 1,282 people
- Sponsor
- Janssen Research & Development, LLC
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
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
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.
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
Psoriasis
A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis
The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.
- Trial name
- NCT01008995
- Testing
- ustekinumab
- Where
- 9 sites in China
- Volunteers
- 322 people
- Sponsor
- Centocor, 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
Psoriasis
A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.
- Trial name
- NCT00747344
- Testing
- Ustekinumab 45 mg - CP, Ustekinumab 45 mg - after CP
- Where
- 5 sites in South Korea, Taiwan
- Volunteers
- 121 people
- Sponsor
- Centocor, Inc.
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