Clinical trials: Crohn Disease
Inflammatory Bowel Diseases
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and…
- Trial name
- NCT06754891
- Testing
- 24mg bid TQH3906 capsule, 32mg TQH3906 capsule
- Where
- 30 sites in China
- Volunteers
- 135 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Healthy
Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
This is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people.
- Trial name
- NCT01162889
- Testing
- ATR-107 (PF-05230900) SC Injection, ATR-107 (PF-05230900) IV Infusion
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Pfizer
Crohn's Disease
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather…
- Trial name
- NCT00686374
- Testing
- Adalimumab
- Volunteers
- 100 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Healthy
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses…
- Trial name
- NCT06715540
- Testing
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biocad
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
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 Disease
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's…
- Trial name
- JUNIPER (NCT02403323)
- Testing
- Etrolizumab
- Where
- 287 sites in United States, Argentina and 31 more
- Volunteers
- 790 people
- Sponsor
- Hoffmann-La Roche
Crohn's Disease
Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to…
- Trial name
- NCT00307931
- Testing
- Certolizumab pegol
- Where
- 5 sites in Greece
- Volunteers
- 16 people
- Sponsor
- UCB Pharma
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.
Inflammatory Bowel Disease, Intestinal Fistula
Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas.
- Trial name
- NCT00321412
- Testing
- AST-120
- Where
- 88 sites in United States, Austria and 10 more
- Volunteers
- 191 people
- Sponsor
- Ocera Therapeutics
Inflammatory Bowel Disease, Colitis, Ulcerative
LMT503 First-in-human SAD, MAD, and FE Study
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and…
- Conditions
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT05659953
- Testing
- LMT503
- Where
- Netherlands
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Lmito Therapeutics Inc.
Crohn's Disease
A Study of Abatacept in Patients With Active Crohn's Disease
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies.
- Trial name
- NCT00406653
- Testing
- abatacept
- Where
- 101 sites in United States, Australia and 15 more
- Volunteers
- 451 people
- Sponsor
- Bristol-Myers Squibb
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.
- Trial name
- SERENITY (NCT02891226)
- Testing
- Mirikizumab
- Where
- 108 sites in United States, Australia and 12 more
- Volunteers
- 191 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
- Trial name
- CARMEN CD 306 (NCT03566823)
- Testing
- Ontamalimab
- Where
- 145 sites in United States, Argentina and 18 more
- Volunteers
- 34 people
- Sponsor
- Shire
Crohn Disease
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT05470985
- Testing
- Ozanimod
- Where
- 46 sites in United States, Australia and 7 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Crohn Disease, Inflammatory Bowel Diseases
Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease
Protocol Summary Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory Crohn's…
- Trial name
- NCT05130983
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Direct Biologics, LLC
Crohn's Disease
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
- Trial name
- NCT02096861
- Testing
- CT-P13, Remicade
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Celltrion
Inflammatory Bowel Disease
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
- Trial name
- NCT00868660
- Testing
- ZP1848
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Zealand Pharma
Crohn Disease
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic…
- Trial name
- NCT00317369
- Testing
- OPC-6535(Tetomilast)
- Where
- 8 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Crohn Disease
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in patients with active Crohn's disease.
- Trial name
- NCT00269854
- Testing
- Infliximab 5 mg/kg, Infliximab 10 mg/kg, Infliximab 20 mg/kg
- Volunteers
- 108 people
- Sponsor
- Centocor, Inc.