Clinical trials: Moderately to Severely Active Crohn's Disease
Crohn's Disease, Inflammatory Bowel Disease
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease, IBD, Colitis
- Trial name
- NCT01369342
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 220 sites in United States, Australia and 20 more
- Volunteers
- 640 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 Disease
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe…
- Trial name
- ICONIC-CD (NCT07196722)
- Testing
- Icotrokinra
- Where
- 395 sites in United States, Argentina and 26 more
- Volunteers
- 1,092 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease.
- Trial name
- SHIELD-4 (NCT01536418)
- Testing
- GSK1605786A
- Where
- 227 sites in United States, Australia and 29 more
- Volunteers
- 255 people
- Sponsor
- GlaxoSmithKline
Crohn's Disease
Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
Objectives: The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d.
- Trial name
- CD (NCT00792740)
- Testing
- ITF2357
- Where
- 10 sites in Belgium, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- Italfarmaco
Crohn Disease
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.
- Trial name
- NCT01218360
- Testing
- Physician standard-of-care
- Volunteers
- 71 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if…
- Trial name
- NCT00771667
- Testing
- Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP), Ustekinumab 6 mg/kg (IP)
- Where
- 174 sites in United States, Australia and 10 more
- Volunteers
- 526 people
- Sponsor
- Centocor, Inc.
Crohn's Disease (CD)
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- COMANDOR (NCT07078994)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 204 people
- Sponsor
- Biocad
Crohn Disease
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
- Trial name
- NCT00206674
- Testing
- Sargramostim (Leukine)
- Where
- 70 sites in Argentina, Australia and 7 more
- Volunteers
- 286 people
- Sponsor
- Genzyme, a Sanofi Company
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
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis…
- Trial name
- NCT02365649
- Testing
- ABT-494
- Volunteers
- 220 people
- Sponsor
- AbbVie
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain.
- Trial name
- PANORAMA (NCT06581328)
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 101 sites in United States
- Volunteers
- 200 people
- Sponsor
- Takeda
Crohn's Disease
Efficacy and Safety of TD-1473 in Crohn's Disease
A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
- Trial name
- DIONE (NCT03635112)
- Testing
- TD-1473
- Where
- 178 sites in United States, Australia and 20 more
- Volunteers
- 167 people
- Sponsor
- Theravance Biopharma
Moderate and Severe Active Rheumatoid Arthritis, Active Psoriatic Arthritis
Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease
The purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and…
- Conditions
- Moderate and Severe Active Rheumatoid Arthritis, Active Psoriatic Arthritis, Active Ankylosing Spondylitis, Moderately to Severely Active Crohn's Disease
- Trial name
- NCT03357471
- Testing
- e-Device
- Where
- 22 sites in United States
- Volunteers
- 70 people
- Sponsor
- UCB Biopharma S.P.R.L.
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
Crohn Disease
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT03464097
- Testing
- Ozanimod
- Where
- 765 sites in United States, Argentina and 47 more
- Volunteers
- 550 people
- Sponsor
- Celgene
Crohn's Disease
A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity 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 Humira (adalimumab) is in treating moderately to severely active CD in China.
- Trial name
- NCT05394805
- Where
- 10 sites in China
- Volunteers
- 156 people
- Sponsor
- AbbVie
Crohns Disease
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
- Trial name
- NCT04397263
- Testing
- Guselkumab
- Where
- 25 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Janssen Pharmaceutical K.K.
Crohn Disease
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
- Trial name
- NCT00265122
- Testing
- Ustekinumab 90 mg, Ustekinumab 4.5 mg/kg
- Where
- 57 sites in United States, Belgium and 1 more
- Volunteers
- 131 people
- Sponsor
- Centocor, Inc.
Crohn's Disease
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
- Trial name
- NCT02065570
- Testing
- Adalimumab
- Where
- 143 sites in United States, Austria and 18 more
- Volunteers
- 514 people
- Sponsor
- AbbVie