Clinical trials: Severe Ulcerative Colitis
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Ulcerative Colitis
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate…
- Trial name
- FIGARO UC 303 (NCT03290781)
- Testing
- Ontamalimab
- Where
- 401 sites in United States, Argentina and 35 more
- Volunteers
- 366 people
- Sponsor
- Shire
Ulcerative Colitis
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT00853099
- Testing
- adalimumab
- Where
- 65 sites in Japan
- Volunteers
- 274 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Ulcerative Colitis
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04706793
- Testing
- Etrasimod
- Where
- 38 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Ulcerative Colitis (UC)
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis…
- Trial name
- U-Accomplish (NCT03653026)
- Testing
- Upadacitinib
- Where
- 379 sites in United States, Argentina and 42 more
- Volunteers
- 522 people
- Sponsor
- AbbVie
Ulcerative Colitis
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
- Trial name
- ELEVATE UC 52 (NCT03945188)
- Testing
- Etrasimod
- Where
- 315 sites in United States, Argentina and 38 more
- Volunteers
- 433 people
- Sponsor
- Arena Pharmaceuticals
Pediatric Ulcerative Colitis
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650…
- Trial name
- NCT01585155
- Testing
- TA-650
- Where
- 7 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Tanabe Pharma Corporation
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis (UC)
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction…
- Trial name
- NCT02819635
- Testing
- Upadacitinib
- Where
- 496 sites in United States, Argentina and 44 more
- Volunteers
- 1,302 people
- Sponsor
- AbbVie
Crohn's Disease, Ulcerative Colitis
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
- Trial name
- NCT03283085
- Testing
- 25 mg Ontamalimab, 75 mg Ontamalimab
- Where
- 419 sites in United States, Argentina and 35 more
- Volunteers
- 557 people
- Sponsor
- Shire
Ulcerative Colitis
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507203
- Testing
- ABX464
- Where
- 264 sites in United States, Argentina and 22 more
- Volunteers
- 639 people
- Sponsor
- Abivax S.A.
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
Ulcerative Colitis (UC)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the…
- Trial name
- NCT03398148
- Testing
- risankizumab IV, risankizumab SC
- Where
- 430 sites in United States, Argentina and 42 more
- Volunteers
- 1,558 people
- Sponsor
- AbbVie
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02065557
- Testing
- Adalimumab
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Ulcerative Colitis
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative…
- Trial name
- FIGARO UC 301 (NCT03259334)
- Testing
- Ontamalimab
- Where
- 207 sites in United States, Australia and 16 more
- Volunteers
- 380 people
- Sponsor
- Shire
Ulcerative Colitis
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
- Trial name
- NCT02039505
- Testing
- Vedolizumab
- Where
- 59 sites in Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
Ulcerative Colitis, Crohn's Disease
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
- Trial name
- FENNEL (NCT03478956)
- Testing
- Etrolizumab
- Where
- 5 sites in Belgium, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ELEVATE UC 12 (NCT03996369)
- Testing
- Etrasimod
- Where
- 407 sites in United States, Argentina and 39 more
- Volunteers
- 354 people
- Sponsor
- Arena Pharmaceuticals
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.