Clinical trials: Ulcerative Colitis, Pediatric
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
Colitis, Ulcerative
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission.
- Trial name
- NCT05076175
- Testing
- Ozanimod
- Where
- 91 sites in United States, Australia and 11 more
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Pediatric Ulcerative Colitis
Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis
This is a Phase I/II, multi-center, open-label proof-of-concept study of vamorolone. Twenty participants with a flare of mild or moderately active Ulcerative Colitis (defined as a Pediatric Ulcerative Colitis Activity Index…
- Trial name
- NCT04348890
- Testing
- Vamorolone 4% suspension for oral dosing
- Sponsor
- ReveraGen BioPharma, Inc.
Crohn's Disease, Ulcerative Colitis
A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD).
- Conditions
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases
- Trial name
- DEVELOP (NCT00606346)
- Testing
- Anti TNF therapy including infliximab, No Biologics
- Where
- 62 sites in United States, Canada
- Volunteers
- 4,970 people
- Sponsor
- Janssen Biotech, Inc.
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
Ulcerative Colitis
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC.
- Trial name
- NCT04624230
- Testing
- tofacitinib
- Where
- 69 sites in United States, Australia and 14 more
- Volunteers
- 118 people
- Sponsor
- Pfizer
Ulcerative Colitis
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
- Trial name
- NCT02632175
- Testing
- Adalimumab
- Where
- 16 sites in United States, Japan and 4 more
- Volunteers
- 59 people
- Sponsor
- AbbVie
Inflammatory Bowel Diseases, Colitis, Ulcerative
Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT02629211
- Testing
- NaviAid™ AB
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Smart Medical Systems Ltd.
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
Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis
Prospective, single-center, sham-controlled, double-blinded 12-week study designed to evaluate the safety and efficacy of the RAVANS device in subjects with Ulcerative Colitis.
- Trial name
- NCT05662059
- Testing
- RAVANS
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Cala Health, Inc.
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
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- MIGHTY (NCT07071519)
- Testing
- Risankizumab
- Where
- 73 sites in United States, Belgium and 14 more
- Volunteers
- 120 people
- Sponsor
- AbbVie
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
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin…
- Trial name
- NCT06100289
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 54 sites in United States, Belgium and 14 more
- Volunteers
- 70 people
- Sponsor
- Takeda
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
Pediatric Ulcerative Colitis
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650…
- Trial name
- NCT01585155
- Testing
- TA-650
- Where
- 7 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Tanabe Pharma Corporation