Clinical trials: Moderate to Severe Ulcerative Colitis
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
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC.
- Trial name
- NCT05743010
- Testing
- APL-1401
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Ulcerative Colitis
Clinical Outcome After Escalation and De-escalation of Adalimumab in Real Life in Ulcerative Colitis
This retrospective multi-centric Belgian observational trial will involve all patients who have initiated adalimumab for moderate-to-severe ulcerative colitis prior to September 1st 2015 in a Belgian centre maintaining a…
- Trial name
- CEDAR UC (NCT03142113)
- Where
- Belgium
- Volunteers
- 231 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin…
- Trial name
- NCT06100289
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 54 sites in United States, Belgium and 14 more
- Volunteers
- 70 people
- Sponsor
- Takeda
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 to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to…
- Trial name
- Falcon (NCT04130919)
- Testing
- Tilpisertib
- Where
- 49 sites in United States, Australia and 7 more
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
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
Colitis, Ulcerative
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active…
- Trial name
- NCT03482635
- Testing
- Spesolimab
- Where
- 54 sites in United States, Austria and 10 more
- Volunteers
- 98 people
- Sponsor
- Boehringer Ingelheim
Ulcerative Colitis
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.
- Trial name
- NCT05372939
- Testing
- AMT-101 (oral), Humira (adalimumab)
- Where
- 18 sites in Georgia, Netherlands and 2 more
- Volunteers
- 51 people
- Sponsor
- Applied Molecular Transport
Ulcerative Colitis
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
- Trial name
- OCTAVE (NCT01470612)
- Testing
- CP-690,550
- Where
- 252 sites in United States, Australia and 29 more
- Volunteers
- 944 people
- Sponsor
- Pfizer
Ulcerative Colitis (UC)
Effectiveness and Safety of Mirikizumab in Patients With Moderate-to-severe Ulcerative Colitis: a Real-life Retrospective Multicenter Study
This is a real-life, multicenter, retrospective observational study with the aim to evaluate effectiveness and safety of Mirikizumab in a real life setting from the baseline up to manteinance at 12, 24 and 52 weeks.
- Trial name
- MIRI REAL (NCT07695636)
- Where
- Italy
- Volunteers
- 282 people
- Sponsor
- IRCCS San Raffaele
Ulcerative Colitis
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- NCT05570006
- Testing
- ABBV-668
- Where
- 30 sites in United States, Belgium and 2 more
- Volunteers
- 30 people
- Sponsor
- AbbVie
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
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to…
- Trial name
- NCT03518086
- Testing
- Mirikizumab
- Where
- 502 sites in United States, Argentina and 33 more
- Volunteers
- 1,281 people
- Sponsor
- Eli Lilly and Company
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 Chronic Moderate, Ulcerative Colitis Chronic Severe
Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis
A Phase Ib/IIa to evaluate the safety and tolerability of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis over 28 days.
- Trial name
- NCT04353791
- Testing
- OST-122
- Where
- 16 sites in Spain, Ukraine
- Volunteers
- 32 people
- Sponsor
- Oncostellae S.L