Clinical trials: Inflammatory Bowel System
Crohns Disease
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
- Trial name
- NCT01769755
- Testing
- PDA001
- Where
- 12 sites in United States
- Volunteers
- 14 people
- Sponsor
- Celularity Incorporated
Ulcerative Colitis, Crohn's Disease
Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).
- Trial name
- NCT02913508
- Testing
- Vedolizumab intravenous injection, Vedolizumab subcutaneous injection
- 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
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT00385736
- Testing
- adalimumab
- Where
- 80 sites in United States, Austria and 11 more
- Volunteers
- 576 people
- Sponsor
- Abbott
Crohn Disease
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in…
- Trial name
- DUET (NCT04655807)
- Testing
- JNJ-64304500, Adalimumab, Ustekinumab
- Where
- United States
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely…
- Trial name
- NCT07483099
- Testing
- LY4395089, Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)
- Where
- 70 sites in United States, Belgium and 8 more
- Volunteers
- 60 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
- Trial name
- GALAXI (NCT03466411)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 579 sites in United States, Australia and 41 more
- Volunteers
- 1,409 people
- Sponsor
- Janssen Research & Development, LLC
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
Colitis, Ulcerative
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release…
- Trial name
- NCT02493712
- Testing
- High dose, Low dose
- Where
- Italy
- Volunteers
- 51 people
- Sponsor
- Holy Stone Healthcare Co., Ltd
Crohn's Disease, IBD
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or…
- Conditions
- Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease
- Trial name
- NCT01369329
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 175 sites in United States, Australia and 21 more
- Volunteers
- 769 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects
This study evaluates the safety and tolerability of TOP1288 rectal single and multiple ascending doses in healthy subjects and multiple doses in subjects with ulcerative colitis.
- Trial name
- NCT02463045
- Testing
- TOP1288
- Where
- United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Topivert Pharma Ltd
Inflammatory Bowel Disease
Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to…
- Trial name
- NCT01017614
- Testing
- Monofer, Iron Sulphate
- Where
- 10 sites in Denmark, India and 1 more
- Volunteers
- 350 people
- Sponsor
- Pharmacosmos A/S
Crohn's Disease
Phase II Study of RR110 in Patients With Active Crohn's Disease
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.
- Trial name
- NCT00417391
- Testing
- RR110 (Tamibarotene)
- Where
- 8 sites in Japan
- Volunteers
- 24 people
- Sponsor
- R&R Inc.
Inflammatory Bowel Diseases, Crohn's Disease
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice.
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
- Trial name
- TARGET-IBD (NCT03251118)
- Where
- 37 sites in United States
- Volunteers
- 15,000 people
- Sponsor
- Target PharmaSolutions, Inc.
Ulcerative Colitis
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of…
- Trial name
- NCT04556383
- Testing
- GB004
- Where
- 77 sites in United States, Georgia and 7 more
- Volunteers
- 236 people
- Sponsor
- GB004, Inc.
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided/Distal Ulcerative Colitis Who Had an Inadequate Response to the Treatment
The study will evaluate the effectiveness, safety and tolerability of tacrolimus lipid suspension for enema in adult patients with mild to moderately active ulcerative colitis who had an inadequate response or intolerance of at…
- Trial name
- NCT06867042
- Testing
- Tacrolimus Lipid Suspension for enema, Identical Tacrolimus-free Lipid Suspension for Enema
- Volunteers
- 150 people
- Sponsor
- Jina Pharmaceuticals Inc.
Crohn Disease, Arthritis, Rheumatoid
Remicade Infusion Management Program
Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate.
- Trial name
- RemiTRAC (NCT00723905)
- Where
- 2 sites in Canada
- Volunteers
- 1,630 people
- Sponsor
- Janssen Inc.
Colitis, Ulcerative
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
- Trial name
- EFFECT-UC (NCT06294925)
- Testing
- Etrasimod
- Where
- 41 sites in Canada, Germany and 1 more
- Volunteers
- 360 people
- Sponsor
- Pfizer
Ulcerative Colitis
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC).
- Trial name
- OCTAVE (NCT01458574)
- Testing
- CP690,550, CP-690,550
- Where
- 275 sites in United States, Australia and 29 more
- Volunteers
- 593 people
- Sponsor
- Pfizer
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2…
- Trial name
- NCT00417690
- Testing
- 4-Aminosalicylic acid
- Where
- 5 sites in United States, Israel
- Volunteers
- 54 people
- Sponsor
- Jacobus Pharmaceutical