A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT05995353
Recruiting
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is bei... Read More
Gender:
All
Ages:
Between 2 years and 17 years
Trial Updated:
11/29/2023
Locations: Riley Hospital for Children /ID# 256454, Indianapolis, Indiana +1 locations
Conditions: Crohn's Disease
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A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
NCT06063967
Recruiting
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/21/2023
Locations: Atlantic Medical Research /ID# 256471, Margate, Florida +4 locations
Conditions: Crohn's Disease
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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
NCT05242471
Recruiting
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Gender:
All
Ages:
Between 18 years and 65 years
Trial Updated:
11/07/2023
Locations: University of Alabama Liver Center, Birmingham, Alabama +302 locations
Conditions: Crohn's Disease
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A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
NCT03251118
Recruiting
TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
Gender:
All
Ages:
2 years and above
Trial Updated:
10/27/2023
Locations: Om Research, Lancaster, California +36 locations
Conditions: Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
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A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
NCT04173273
Recruiting
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Exten... Read More
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
10/25/2023
Locations: Center for Digestive Health (Endoscopy Location), Dothan, Alabama +785 locations
Conditions: Crohn's Disease
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A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
NCT04232553
Recruiting
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
Gender:
All
Ages:
18 years and above
Trial Updated:
10/18/2023
Locations: Digestive Health Specialists, Dothan, Alabama +261 locations
Conditions: Crohn's Disease
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A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
NCT04844606
Recruiting
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.
Gender:
All
Ages:
Between 2 years and 19 years
Trial Updated:
10/10/2023
Locations: Icahn School of Medicine at Mount Sinai, New York, New York +6 locations
Conditions: Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease
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ENhanced Recovery in CHildren Undergoing Surgery
NCT04060303
Recruiting
The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are lacking. The Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery, which has the short title "ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US)," study is a multicenter, pragma... Read More
Gender:
All
Ages:
Between 10 years and 18 years
Trial Updated:
10/06/2023
Locations: Northwestern University, Chicago, Illinois
Conditions: Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
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Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
NCT04847739
Recruiting
A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive s... Read More
Gender:
All
Ages:
Between 18 years and 70 years
Trial Updated:
09/27/2023
Locations: Mayo Clinic Arizona, Phoenix, Arizona +15 locations
Conditions: Perianal Fistula, Crohn's Disease
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Study of ExoFlo for the Treatment of Perianal Fistulas
NCT05836883
Recruiting
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
08/31/2023
Locations: Phillip Fleshner, MD, Los Angeles, California
Conditions: Perianal Fistula, Crohn's Disease
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A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
NCT04809363
Recruiting
CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.
Gender:
All
Ages:
18 years and above
Trial Updated:
08/23/2023
Locations: Arizona Arthritis & Rheumatology Research, PLLC, Phoenix, Arizona +54 locations
Conditions: Crohn's Disease
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Empagliflozin as a Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency
NCT05078879
Recruiting
Background: Severe congenital neutropenia (SCN) is an immune system disease. People with SCN do not have enough of a kind of white blood cell called neutrophils. This means they get sick easily from infections. Some drugs to treat SCN have lots of side effects. Researchers want to see if a the drug empagliflozin can help increase the number of neutrophils in a person with SCN. Objective: To see if a drug called empagliflozin can help people with SCN. Eligibility: Adults aged 18 and older wi... Read More
Gender:
All
Ages:
Between 18 years and 85 years
Trial Updated:
07/25/2023
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland
Conditions: Crohn's Disease, Glycogen Metabolism, Inflammatory Bowel Disease (IBD)
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