Clinical trials: Severe Crohn's Disease, active
Ulcerative Colitis, Crohn's Disease
A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD).
- Trial name
- NCT04738942
- Testing
- Vedolizumab
- Where
- 20 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Takeda
Crohn's Disease
An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world.
- Trial name
- NCT06023030
- Where
- 104 sites in Japan
- Volunteers
- 240 people
- Sponsor
- AbbVie
Ulcerative Colitis, Crohn's Disease
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
This is an open-label, single group, 2-period, Phase 1, single-arm study. The primary purpose of this study is to investigate the effects of duvakitug on the pharmacokinetics of selected cytochrome P450 substrates in adult…
- Trial name
- NCT07923383
- Testing
- Duvakitug
- Volunteers
- 25 people
- Sponsor
- Sanofi
Crohn's Disease
Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world.
- Trial name
- UPlift (NCT05930275)
- Where
- 180 sites in Australia, Bulgaria and 15 more
- Volunteers
- 1,200 people
- Sponsor
- AbbVie
Crohn's Disease, Ulcerative Colitis
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel.
- Trial name
- NCT06764615
- Testing
- Zasocitinib
- Where
- 16 sites in United States, China and 6 more
- Volunteers
- 192 people
- Sponsor
- Takeda
Crohn's Disease
A Study of SL-325 in Crohn's Disease Patients
The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.
- Trial name
- RECEPTIVE-CD1 (NCT07753850)
- Testing
- SL-325
- Where
- 20 sites in United States
- Volunteers
- 232 people
- Sponsor
- Shattuck Labs, Inc.
Crohn's Disease, Obesity or Overweight
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and…
- Trial name
- COMMIT-CD (NCT06937099)
- Testing
- Mirikizumab, Tirzepatide
- Where
- 183 sites in United States, Austria and 20 more
- Volunteers
- 290 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China.
- Trial name
- NCT05837897
- Testing
- Vedolizumab IV
- Where
- 43 sites in China
- Volunteers
- 408 people
- Sponsor
- Takeda
Crohn's Disease (CD)
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab.
- Trial name
- NCT04779320
- Testing
- Vedolizumab IV
- Where
- 96 sites in United States, Australia and 16 more
- Volunteers
- 120 people
- Sponsor
- Takeda
Crohn Disease
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe…
- Trial name
- ICONIC-CD (NCT07196722)
- Testing
- Icotrokinra
- Where
- 395 sites in United States, Argentina and 26 more
- Volunteers
- 1,092 people
- Sponsor
- Janssen Research & Development, LLC
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes
Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC
This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- PRO-RIC (NCT04528355)
- Testing
- data collection
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paul Szabolcs
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)
Ulcerative Colitis (UC), Crohn's Diseases
Cardiovascular Risk in Patients With IBD
In this study the Research Hospital San Donato Policlinic ask the participation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease.
- Conditions
- Ulcerative Colitis (UC), Crohn's Diseases, Cardiovascular Risk
- Trial name
- DICOM-IBD (NCT07663201)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- IRCCS Policlinico S. Donato
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
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
Post-Acute COVID-19 Syndrome, ME/CFS
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related…
- Conditions
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA)
- Trial name
- NCT04806620
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Brain Inflammation Collaborative
Crohn Disease (CD), Ulcerative Colitis (UC)
Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial
Fatigue is a big problem in people with inflammatory bowel disease (IBD). Even when IBD is well controlled, 50% of patients remain fatigued most of the time. Fatigue can be physical (e.g. feeling tired or weak) and mental (e.g.
- Conditions
- Crohn Disease (CD), Ulcerative Colitis (UC), Fatigue
- Trial name
- MFI (NCT07295834)
- Testing
- Modafinil
- Where
- 4 sites in United Kingdom
- Volunteers
- 70 people
- Sponsor
- Imperial College London
Colitis, Ulcerative, Crohn Disease
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group.
- Trial name
- NCT07483073
- Testing
- Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC), LY4395089
- Where
- 71 sites in United States, Belgium and 8 more
- Volunteers
- 60 people
- Sponsor
- Eli Lilly and Company