Clinical trials: Moderately to Severely Active Crohns Disease
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
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
- Trial name
- VIVID-1 (NCT03926130)
- Testing
- Mirikizumab, Ustekinumab
- Where
- 580 sites in United States, Argentina and 32 more
- Volunteers
- 1,158 people
- Sponsor
- Eli Lilly and Company
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease (CD)
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab.
- Trial name
- NCT04779320
- Testing
- Vedolizumab IV
- Where
- 96 sites in United States, Australia and 16 more
- Volunteers
- 120 people
- Sponsor
- Takeda
Crohn's Disease
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
- Trial name
- NCT03104413
- Testing
- risankizumab SC, risankizumab IV
- Where
- 403 sites in United States, Argentina and 41 more
- Volunteers
- 618 people
- Sponsor
- AbbVie
Crohn's Disease
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD).
- Trial name
- NCT00055367
- Testing
- natalizumab
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Biogen
Moderately to Severely Active Crohns Disease
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's…
- Trial name
- SIBERITE-2 (NCT06819891)
- Testing
- Afimkibart
- Where
- 208 sites in United States, Argentina and 25 more
- Volunteers
- 425 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure…
- Trial name
- UNITI Jr (NCT04673357)
- Testing
- Ustekinumab
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 101 people
- Sponsor
- Janssen Research & Development, LLC
Moderately to Severely Active Crohns Disease
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
- Trial name
- SIBERITE-PEDS (NCT07298421)
- Testing
- Afimkibart
- Where
- 19 sites in United States, Australia and 6 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Crohn's Disease
An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world.
- Trial name
- APPRISE (NCT05841537)
- Where
- 154 sites in Austria, Canada and 9 more
- Volunteers
- 1,019 people
- Sponsor
- AbbVie
Crohn's Disease
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels.
- Trial name
- U-EMPOWER (NCT06332534)
- Testing
- Upadacitinib
- Where
- 85 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- AbbVie
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
Crohn's Disease
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
- Trial name
- NCT04643483
- Testing
- Certolizumab pegol, Adalimumab
- Sponsor
- UCB Biopharma SRL
Crohn's Disease
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely…
- Trial name
- STARSCAPE-1 (NCT07184931)
- Testing
- Duvakitug
- Where
- 461 sites in United States, Argentina and 34 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Crohn Disease
A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease
This trial aims to investigate the safety, tolerability and clinical activity of humanised antibody GSK1070806 delivered via intravenous infusion in the treatment of patients with moderate-to-severe Crohn's disease.
- Trial name
- CDAID (NCT03681067)
- Testing
- GSK1070806
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- University of Birmingham
Moderately to Severely Active Crohns Disease
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with…
- Trial name
- SIBERITE-1 (NCT06819878)
- Testing
- Afimkibart
- Where
- 375 sites in United States, Argentina and 36 more
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
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
Crohn's Disease
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD).
- Trial name
- STARSCAPE-2 (NCT07184944)
- Testing
- Duvakitug
- Where
- 109 sites in United States, Australia and 25 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
Crohn's Disease
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical…
- Trial name
- MACARONI-23 (NCT05923073)
- Testing
- Guselkumab
- Where
- 85 sites in United States, Australia and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
- Trial name
- NCT03105128
- Testing
- risankizumab IV, risankizumab SC
- Where
- 475 sites in United States, Argentina and 42 more
- Volunteers
- 931 people
- Sponsor
- AbbVie