Clinical trials: Colitis Ulcerative
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
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- EMERALD-2 (NCT05611671)
- Testing
- MORF-057
- Where
- 102 sites in United States, Australia and 19 more
- Volunteers
- 280 people
- Sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
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
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- QUASAR (NCT04033445)
- Testing
- Guselkumab
- Where
- 392 sites in United States, Argentina and 32 more
- Volunteers
- 1,064 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ASTRO (NCT05528510)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 236 sites in United States, Argentina and 23 more
- Volunteers
- 418 people
- Sponsor
- Janssen Research & Development, LLC
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.
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.
Ulcerative Colitis
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- ARTEMIS-UC (NCT04996797)
- Testing
- Tulisokibart, Companion Diagnostic (CDx) Testing
- Where
- 88 sites in United States, Australia and 10 more
- Volunteers
- 178 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Moderate to Severe Ulcerative Colitis
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo.
- Trial name
- NCT04090411
- Testing
- Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, Induction- PF-06480605 450 mg SC Q4W
- Where
- 166 sites in United States, Australia and 21 more
- Volunteers
- 246 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis, IBD
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by…
- Trial name
- Expedition (NCT03616821)
- Testing
- Brazikumab
- Where
- 125 sites in United States, Canada and 17 more
- Volunteers
- 242 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Open-label Extension Study of Brazikumab in Ulcerative Colitis
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term…
- Trial name
- Expedition (NCT04277546)
- Testing
- Brazikumab Maintenance Dose, Brazikumab Induction Dose
- Where
- 36 sites in United States, Czechia and 9 more
- Volunteers
- 57 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.
- Trial name
- CoTikiS (NCT04882007)
- Testing
- OSE-127
- Where
- 55 sites in Belarus, Belgium and 9 more
- Volunteers
- 136 people
- Sponsor
- OSE Immunotherapeutics
Ulcerative Colitis, Crohn's Disease
A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD).
- Trial name
- NCT04738942
- Testing
- Vedolizumab
- Where
- 20 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Takeda
Ulcerative Colitis
Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT05785715
- Testing
- NX-13 250mg, NX-13 750mg
- Where
- 35 sites in United States, Belgium and 2 more
- Volunteers
- 81 people
- Sponsor
- AbbVie
Ulcerative Colitis, Ulcerative Colitis Chronic
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
- Trial name
- LUCENT-URGE (NCT05767021)
- Testing
- Mirikizumab
- Where
- 120 sites in United States, Belgium and 8 more
- Volunteers
- 172 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis, Crohn's Disease
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
- Trial name
- NCT03196427
- Testing
- Vedolizumab
- Where
- 23 sites in United States, France and 5 more
- Volunteers
- 59 people
- Sponsor
- Takeda
Ulcerative Colitis
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
- Trial name
- LUCENT 2 (NCT03524092)
- Testing
- Mirikizumab SC, Mirikizumab IV
- Where
- 385 sites in United States, Argentina and 32 more
- Volunteers
- 1,328 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
- Trial name
- NCT04023396
- Testing
- ABX464
- Where
- 120 sites in Austria, Belarus and 14 more
- Volunteers
- 217 people
- Sponsor
- Abivax S.A.
Colitis, Ulcerative
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
- Trial name
- NCT04779307
- Testing
- Vedolizumab
- Where
- 65 sites in United States, Australia and 12 more
- Volunteers
- 121 people
- Sponsor
- Takeda
Colitis, Ulcerative
VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT05156125
- Testing
- VTX002
- Where
- 77 sites in United States, Bulgaria and 12 more
- Volunteers
- 213 people
- Sponsor
- Oppilan Pharma Ltd