Clinical trials: Ulcerative Colitis, Active Severe
Ulcerative Colitis
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and…
- Trial name
- SELECTION (NCT02914522)
- Testing
- Filgotinib, PTM filgotinib
- Where
- 343 sites in United States, Argentina and 38 more
- Volunteers
- 1,351 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis (UC)
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT02065622
- Testing
- Adalimumab
- Where
- 173 sites in United States, Austria and 18 more
- Volunteers
- 952 people
- Sponsor
- AbbVie
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
Colitis, Ulcerative
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely…
- Trial name
- LAUREL (NCT02165215)
- Testing
- Etrolizumab
- Where
- 104 sites in United States, Brazil and 13 more
- Volunteers
- 359 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
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
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
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 Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
- Trial name
- NCT05061446
- Testing
- Etrasimod
- Where
- 80 sites in Japan
- Volunteers
- 54 people
- Sponsor
- Pfizer
Ulcerative Colitis
Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study…
- Trial name
- NCT03368118
- Testing
- ABX464
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- Abivax S.A.
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
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
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active…
- Trial name
- NCT03093259
- Testing
- ABX464
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 32 people
- Sponsor
- Abivax S.A.
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
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
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
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with…
- Trial name
- HICKORY (NCT02100696)
- Testing
- Etrozulimab
- Where
- 184 sites in United States, Argentina and 22 more
- Volunteers
- 609 people
- Sponsor
- Hoffmann-La Roche
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
Ulcerative Colitis
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02895100
- Testing
- PTG-100
- Where
- 98 sites in United States, Australia and 15 more
- Volunteers
- 98 people
- Sponsor
- Protagonist Therapeutics, Inc.
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.