Clinical trials: Pediatric Inflammatory Bowel Diseases
Crohn's Disease, Ulcerative Colitis
Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the…
- Trial name
- NCT06856135
- Testing
- Vedolizumab IV
- Where
- 3 sites in United States
- Sponsor
- Takeda
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.
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Colitis, Ulcerative
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years…
- Trial name
- ELEVATE-UCkids (NCT07470879)
- Testing
- Etrasimod
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Inflammatory Bowel Diseases
A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea
The purpose of this study is: to find out out the number of children who develop crohn's disease (CD) and ulcerative colitis (UC) each year and are living with the disease and to see how this differs by age groups.
- Trial name
- Ped IBD Claims (NCT07520747)
- Where
- South Korea
- Volunteers
- 8,000 people
- Sponsor
- Janssen Korea, Ltd., Korea
Crohn's Disease
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
- Trial name
- CAPE (NCT02130362)
- Where
- 148 sites in United States, Bosnia and Herzegovina and 20 more
- Volunteers
- 1,446 people
- Sponsor
- AbbVie
Ulcerative Colitis
ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis
Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments…
- Trial name
- NCT00781638
- Testing
- Adacolumn®
- Volunteers
- 24 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Crohn's Disease
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
- Trial name
- NCT00409682
- Testing
- Adalimumab
- Where
- 45 sites in United States, Belgium and 6 more
- Volunteers
- 192 people
- Sponsor
- Abbott
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- SHINE-2 (NCT05784246)
- Testing
- Mirikizumab IV, Mirikizumab SC
- Where
- 34 sites in United States, Belgium and 9 more
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Crohn Disease
A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease
A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease
- Trial name
- NCT00207675
- Testing
- infliximab
- Volunteers
- 112 people
- Sponsor
- Centocor, Inc.
Crohns Disease, Colitis, Ulcerative
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile…
- Conditions
- Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile
- Trial name
- TRILOGY (NCT06663332)
- Testing
- Guselkumab
- Where
- 51 sites in United States, Argentina and 15 more
- Volunteers
- 196 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Colitis, Ulcerative
A Long-term Extension Study of Ustekinumab in Pediatric Participants
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
- Conditions
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
- Trial name
- UNITED (NCT05092269)
- Testing
- Ustekinumab
- Where
- 48 sites in United States, Argentina and 11 more
- Volunteers
- 159 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50…
- Trial name
- NCT00495521
- Testing
- 4-Aminosalicylic acid extended release granules
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jacobus Pharmaceutical
Ulcerative Colitis, Crohn's Disease
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
- Trial name
- FENNEL (NCT03478956)
- Testing
- Etrolizumab
- Where
- 5 sites in Belgium, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
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
Ulcerative Colitis, Crohn's Disease
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
- Trial name
- NCT03138655
- Testing
- Vedolizumab
- Where
- 88 sites in United States, Belgium and 9 more
- Volunteers
- 89 people
- Sponsor
- Takeda
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
Ulcerative Colitis, Ulcerative Colitis Chronic
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
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).
- Conditions
- Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease
- Trial name
- SHINE-ON (NCT04844606)
- Testing
- Mirikizumab
- Where
- 69 sites in United States, Austria and 14 more
- Volunteers
- 150 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
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
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever.
- Trial name
- RISE (NCT05995353)
- Testing
- Risankizumab
- Where
- 85 sites in United States, Belgium and 19 more
- Volunteers
- 110 people
- Sponsor
- AbbVie
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
- Trial name
- NCT04701411
- Testing
- Darvadstrocel
- Where
- 22 sites in Israel, Japan and 3 more
- Volunteers
- 7 people
- Sponsor
- Takeda