Clinical trials: Inflammatory Bowel Diseases
UC - Ulcerative Colitis
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and cytokine profiles of LYNC-101 for Injection in healthy adult participants.
- Trial name
- NCT07505030
- Testing
- LYNC-101
- Where
- Australia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LyncBio Therapeutics Co., Ltd.
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Crohn's Disease
CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
The objective of this program is to allow treating physicians to supply/continue to supply Certolizumab Pegol (CIMZIA®, CZP) to adults suffering from Crohn's Disease (CD), and who are considered not suitable for treatment…
- Trial name
- COMPAS (NCT03559660)
- Testing
- Certolizumab Pegol
- Sponsor
- UCB Biopharma SRL
Crohn's Disease
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease…
- Trial name
- NCT01258205
- Testing
- AMG 139
- Where
- 7 sites in United States, Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Rheumatoid Arthritis (RA), Inflammatory Bowel Disease - IBD1
Phase I Clinical Study of ZL-82 Tablets
ZL-82 is an oral janus kinase (JAK) inhibitor. In vitro biological mass spectrometry identification test proves that ZL-82 can selectively and irreversibly inhibit JAK3.
- Trial name
- NCT06055023
- Testing
- ZL-82 12.5mg, ZL-82 25mg, ZL-82 50mg
- Where
- China
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Crohn's Disease
A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world…
- Trial name
- CROHNOS (NCT07073079)
- Where
- 25 sites in Italy
- Volunteers
- 250 people
- Sponsor
- AbbVie
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to…
- Trial name
- GARDENIA (NCT02136069)
- Testing
- Etrolizumab, Infliximab
- Where
- 119 sites in Austria, Belgium and 18 more
- Volunteers
- 397 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
- Trial name
- NCT00207688
- Testing
- Infliximab 5 mg/kg, Infliximab 10 mg/kg
- Where
- 102 sites in United States, Argentina and 13 more
- Volunteers
- 505 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis, Inflammatory Bowel Diseases
Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis
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 ulcerative…
- Trial name
- NCT05176366
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Direct Biologics, LLC
Malnutrition, Cancer
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition…
- Conditions
- Malnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- NCT06055543
- Testing
- Fortimel
- Where
- 6 sites in Spain
- Volunteers
- 140 people
- Sponsor
- Danone Specialized Nutrition
Ulcerative Colitis (UC)
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had…
- Trial name
- U-ACTIVATE (NCT03006068)
- Testing
- Upadacitinib (ABT-494)
- Where
- 492 sites in United States, Argentina and 44 more
- Volunteers
- 950 people
- Sponsor
- AbbVie
Crohn's Disease
One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs.
- Trial name
- NCT02240108
- Testing
- Rifaximin EIR
- Where
- 78 sites in United States
- Volunteers
- 81 people
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
- Trial name
- GEMINI I (NCT00783718)
- Testing
- vedolizumab
- Where
- 105 sites in United States, Canada and 1 more
- Volunteers
- 895 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Colitis, Ulcerative
Confirmatory Clinical Study in Active Ulcerative Colitis
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects.
- Trial name
- StarFish-UC (NCT07296315)
- Testing
- Low-dose MH002, High-dose MH002
- Where
- 49 sites in United States, Czechia and 5 more
- Volunteers
- 204 people
- Sponsor
- MRM Health NV
Crohn Disease, Rectal Fistula
A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical…
- Trial name
- INTUITION-CPF (NCT04844593)
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Takeda
Ulcerative Colitis
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.
- Trial name
- NCT00219414
- Testing
- Adacolumn Apheresis System
- Volunteers
- 42 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Primary Sclerosing Cholangitis (PSC)
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Trial name
- NCT06699121
- Testing
- LB-P8 low-dose, LB-P8 high-dose
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- LISCure Biosciences
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine. MGT-006 is an investigational oral capsule containing viable gut microbiota from screened human donors.
- Trial name
- ROOT (NCT07913347)
- Testing
- MGT-006, Vancomycin hydrochloride, Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
- Where
- 12 sites in United States, Japan
- Volunteers
- 54 people
- Sponsor
- Metagen Therapeutics, Inc.
Ulcerative Colitis
A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis.
- Trial name
- NCT00096655
- Testing
- Infliximab
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.
Crohn's Disease
CP-461 for the Treatment of Crohn's Disease
Patients with moderately to severely active Crohn's disease will be treated with oral CP-461 200 mg (2 x 100 mg capsules) twice-daily for 8 weeks.
- Trial name
- NCT00042055
- Testing
- CP-461
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Inc
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