Clinical trials: Ulcerative Colitis, Active Severe
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- AMETRINE-SC (NCT07846683)
- Testing
- Afimkibart
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis (UC), Severe Ulcerative Colitis
A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis
The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body…
- Conditions
- Ulcerative Colitis (UC), Severe Ulcerative Colitis, Moderate Ulcerative Colitis
- Trial name
- ASCENTRA-UC (NCT07845487)
- Testing
- PALI-2108
- Where
- 115 sites in United States, Canada and 10 more
- Volunteers
- 204 people
- Sponsor
- Palisade Bio
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
Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis
The aim of this study is to assess the relationship between microscopic Geboes index of inflammation and clinical course of ulcerative colitis in patients treated with infliximab.
- Trial name
- HERICA (NCT01408810)
- Testing
- Infliximab
- Where
- Portugal
- Volunteers
- 21 people
- Sponsor
- Grupo de Estudo da Doença Inflamatória Intestinal
Ulcerative Colitis
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age).
- Trial name
- NCT05287126
- Testing
- Etrasimod
- Where
- 45 sites in United States, Japan and 3 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
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
Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or…
- Trial name
- TNF (NCT03298022)
- Testing
- ALTB-168
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- AltruBio Inc.
Ulcerative Colitis
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- SUNSCAPE-2 (NCT07185009)
- Testing
- Duvakitug
- Where
- 171 sites in United States, Argentina and 29 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
Colitis Ulcerative
A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))
The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active…
- Trial name
- NCT05731128
- Testing
- Dupilumab
- Where
- 77 sites in United States, Argentina and 9 more
- Volunteers
- 68 people
- Sponsor
- Sanofi
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer
Ulcerative Colitis (UC)
Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis
The purpose of this phase III, multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Hemay005 compared to placebo as induction and maintenance therapy in Chinese participants with…
- Trial name
- NCT07650942
- Testing
- Hemay005 tablet
- Where
- 2 sites in China
- Volunteers
- 360 people
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Ulcerative Colitis (UC)
A Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)
This is an open-label, single-arm, single-center study to evaluate the safety, pharmacokinetics, and efficacy signal of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC).
- Trial name
- NCT07062185
- Testing
- ENC1018 capsule administration group
- Volunteers
- 10 people
- Sponsor
- Tang-Du Hospital
Ulcerative Colitis (UC)
Efficacy & Safety of TD-1473 in Ulcerative Colitis
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
- Trial name
- RHEA (NCT03758443)
- Testing
- TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
- Where
- 188 sites in United States, Australia and 20 more
- Volunteers
- 239 people
- Sponsor
- Theravance Biopharma
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
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