Clinical trials: Moderate Active Ulcerative Colitis
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
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 (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, Digestive System Diseases
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC)…
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis
- Trial name
- NCT02647866
- Testing
- KHK4083
- Where
- 23 sites in United States, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Kyowa Kirin, Inc.
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
Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)
This study will be performed to compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate-to-severe active ulcerative colitis using oral prednisolone + oral 5-aminosalicylic acid (5-ASA) or…
- Trial name
- MUNIX (NCT00984568)
- Testing
- Infliximab, Prednisolone, 5-aminosalicylic acid
- Volunteers
- 28 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the…
- Trial name
- NCT00679432
- Testing
- Blood sampling, endoscopy, budesonide-MMX® 6 mg, budesonide-MMX® 9 mg
- Where
- 105 sites in United States, Canada and 2 more
- Volunteers
- 510 people
- Sponsor
- Bausch Health Americas, Inc.
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
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of…
- Trial name
- NCT06137183
- Testing
- Vixarelimab
- Where
- 65 sites in United States, Brazil and 10 more
- Volunteers
- 79 people
- Sponsor
- Genentech, Inc.
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
Colitis, Ulcerative
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting anti-inflammatory compound, aimed at obtaining initial information on the tolerability, safety, pharmacokinetics (including concentrations in…
- Trial name
- NCT01036022
- Testing
- GSK1399686
- Where
- 26 sites in Belgium, Canada and 3 more
- Volunteers
- 120 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis.
- Trial name
- NCT03675477
- Testing
- SHR0302
- Where
- 67 sites in United States, China and 3 more
- Volunteers
- 164 people
- Sponsor
- Reistone Biopharma Company Limited
Ulcerative Colitis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
The primary objectives of this study are as follows: To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as…
- Trial name
- NCT01831427
- Testing
- Andecaliximab
- Where
- 16 sites in United States, Belgium and 5 more
- Volunteers
- 74 people
- Sponsor
- Gilead Sciences
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.
Colitis, Ulcerative
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
- Trial name
- NCT00487539
- Testing
- Golimumab 100 mg, Golimumab 200 mg, Golimumab 400 mg
- Where
- 200 sites in United States, Australia and 23 more
- Volunteers
- 1,065 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis…
- Trial name
- OCTAVE (NCT01458951)
- Testing
- tofacitinib
- Where
- 182 sites in United States, Australia and 27 more
- Volunteers
- 547 people
- Sponsor
- Pfizer
Ulcerative Colitis
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection.
- Trial name
- NCT01482884
- Testing
- tralokinumab
- Where
- 28 sites in Czechia, France and 4 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
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
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
Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.
- Trial name
- NCT00659802
- Testing
- HMPL-004 low dose, HMPL-004 high dose
- Volunteers
- 224 people
- Sponsor
- Hutchison Medipharma Limited