Clinical trials: Gastroenteritis, open to volunteers
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
Ulcerative Colitis
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects…
- Trial name
- NCT04314375
- Testing
- Low Dose Budesonide, High Dose Budesonide
- Where
- 4 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bausch Health Americas, Inc.
Crohn Disease, Colitis, Ulcerative
A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD)…
- Trial name
- GusTaCon (NCT07746765)
- Volunteers
- 35 people
- Sponsor
- Janssen Sciences Ireland UC
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
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention.
- Trial name
- AMAY (NCT05509777)
- Testing
- Mirikizumab
- Where
- 81 sites in United States, Austria and 14 more
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
Eosinophilic Esophagitis (EoE)
Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis
This study aims to introduce a new dietary therapy for Eosinophilic Esophagitis (EoE) patients by using partial enteral nutrition (PEN) to enhance remission rates and explore how this approach affects immune function, gut…
- Trial name
- NCT07234825
- Testing
- Partial enteral nutrition (PEN) with dairy elimination, Dairy elimination alone
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Kate Farms Inc
Colitis Ulcerative, Ulcerative Colitis
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT07463183
- Testing
- MK-8690
- Where
- 39 sites in United States, Canada and 9 more
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn Disease (CD)
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice…
- Trial name
- NCT07077681
- Where
- 11 sites in France
- Volunteers
- 246 people
- Sponsor
- EG Labo
Oral Mucositis, Quality of Life
Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.
The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid…
- Conditions
- Oral Mucositis, Quality of Life, Mucositis, Pain
- Trial name
- STOPOMP (NCT05635929)
- Testing
- XCM-OM118 Composition comprising olive oil, betaine and xylitol
- Where
- Spain
- Volunteers
- 63 people
- Sponsor
- Mucosa Innovations, S.L.
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies.
- Trial name
- NCT05442567
- Testing
- Vedolizumab IV, No Intervention
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 240 people
- Sponsor
- Takeda
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
- Trial name
- EMERALD-3 (NCT07415044)
- Testing
- LY4268989
- Where
- 258 sites in United States, Argentina and 26 more
- Volunteers
- 1,431 people
- Sponsor
- Eli Lilly and Company
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
- Trial name
- NCT07900945
- Testing
- CM551
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Ulcerative Colitis (UC)
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
This study will evaluate the efficacy and safety of 627 in patients with UC.
- Trial name
- NCT07507513
- Testing
- 627
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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.
Chronic Disease, HIV/AIDS
Observational Pharmaco-Epidemiology Research & Analysis
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management…
- Conditions
- Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases
- Trial name
- OPERA (NCT03813862)
- Testing
- Non-interventional (observational only)
- Where
- United States
- Volunteers
- 2,000,000 people, healthy volunteers welcome
- Sponsor
- Epividian
Inflammatory Bowel Disease (IBD)
Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such…
- Trial name
- ELITE (NCT06502873)
- Testing
- biological samples collection
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Artialis
Inflammatory Bowel Disease
A Clinical Study of SPH7854 Granules in Healthy Subjects.
To evaluate the safety of SPH7854 in healthy subjects.
- Trial name
- NCT06483373
- Testing
- SPH7854
- Where
- China
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Ulcerative Colitis
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.
- Trial name
- NCT07265570
- Testing
- ISM5411 tablets
- Where
- 28 sites in China
- Volunteers
- 80 people
- Sponsor
- InSilico Medicine Hong Kong Limited