Clinical trials: Moderate to Severe Crohn's Disease
Inflammatory Disease, Disease Crohn
InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in…
- Conditions
- Inflammatory Disease, Disease Crohn, Bowel Disease
- Trial name
- DIRECTCD (NCT06059989)
- Testing
- Infliximab subcutaneous, Immunosuppressive Agents
- Where
- Netherlands
- Volunteers
- 158 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Crohn's Disease
An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease.
- Trial name
- SHIELD-4 (NCT01536418)
- Testing
- GSK1605786A
- Where
- 227 sites in United States, Australia and 29 more
- Volunteers
- 255 people
- Sponsor
- GlaxoSmithKline
Crohn's Disease
Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
Objectives: The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d.
- Trial name
- CD (NCT00792740)
- Testing
- ITF2357
- Where
- 10 sites in Belgium, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- Italfarmaco
Crohn Disease
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.
- Trial name
- NCT01218360
- Testing
- Physician standard-of-care
- Volunteers
- 71 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease
Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease
The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein [hs-CRP] and…
- Trial name
- CALM (NCT01235689)
- Testing
- Adalimumab, Prednisone, Azathioprine
- Volunteers
- 252 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Inflammatory Bowel Disease
Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease
The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis or Crohn's Disease.
- Trial name
- NCT03414788
- Testing
- PF 06687234, [124I]IB PF 06687234
- Where
- United States
- Sponsor
- Pfizer
Crohn's Disease
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission…
- Trial name
- GEMINI II (NCT00783692)
- Testing
- vedolizumab
- Where
- 114 sites in United States, Canada and 1 more
- Volunteers
- 1,116 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Inflammatory Bowel Disease, Ulcerative Colitis
Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease
The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- Trial name
- OACIS (NCT02846961)
- Where
- South Korea
- Volunteers
- 280 people
- Sponsor
- Kyungpook National University Hospital
Crohn's Disease
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if…
- Trial name
- NCT00771667
- Testing
- Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP), Ustekinumab 6 mg/kg (IP)
- Where
- 174 sites in United States, Australia and 10 more
- Volunteers
- 526 people
- Sponsor
- Centocor, Inc.
Crohn's Disease
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
STA-5326 is an oral experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells.
- Trial name
- NCT00234741
- Testing
- STA-5326 mesylate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Synta Pharmaceuticals Corp.
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Crohns Disease
Treatment of Moderate to Severe Refractory Crohn's Disease
This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD).
- Trial name
- NCT06721962
- Testing
- TRX103, Cyclophosphamide
- Where
- 13 sites in United States
- Volunteers
- 39 people
- Sponsor
- Tr1X, Inc.
Crohn's Disease (CD)
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- COMANDOR (NCT07078994)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 204 people
- Sponsor
- Biocad
Crohn's Disease
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's…
- Trial name
- NCT06045754
- Testing
- Vedolizumab, Adalimumab, Ustekinumab
- Where
- 48 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Takeda
Crohn Disease
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
- Trial name
- NCT00206674
- Testing
- Sargramostim (Leukine)
- Where
- 70 sites in Argentina, Australia and 7 more
- Volunteers
- 286 people
- Sponsor
- Genzyme, a Sanofi Company
Crohn's Disease
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
- Trial name
- NCT03104413
- Testing
- risankizumab SC, risankizumab IV
- Where
- 403 sites in United States, Argentina and 41 more
- Volunteers
- 618 people
- Sponsor
- AbbVie
Crohn's Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis…
- Trial name
- NCT02365649
- Testing
- ABT-494
- Volunteers
- 220 people
- Sponsor
- AbbVie
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain.
- Trial name
- PANORAMA (NCT06581328)
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 101 sites in United States
- Volunteers
- 200 people
- Sponsor
- Takeda
Crohn Disease
CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.
- Trial name
- CD02 (NCT00038766)
- Testing
- semapimod
- Where
- 13 sites in United States
- Volunteers
- 33 people
- Sponsor
- Ferring Pharmaceuticals
Crohn's Disease
Efficacy and Safety of TD-1473 in Crohn's Disease
A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
- Trial name
- DIONE (NCT03635112)
- Testing
- TD-1473
- Where
- 178 sites in United States, Australia and 20 more
- Volunteers
- 167 people
- Sponsor
- Theravance Biopharma