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A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants With Moderately to Severely Active Crohn's Disease (CD)
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase...
18 Years - 80 YearsLearn More -
A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccine ChAdOx2 HAV in Healthy Adult Volunteers
A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccine ChAdOx2 HAV in healthy volunteers. Volunteers will be recruited and vaccinated in Oxford, England. All vaccinations will be administered intramuscularly. Three different doses will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp). The total duration of the study will be 52 weeks from the day of enrolment for all volunteers.
18 Years - 50 YearsLearn More -
A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study
This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 130 patients with 'early CD' defined as disease duration < 24 months and no other treatments than corticosteroids and 130 patients with 'late CD' defined as active disease despite treatment with immunosuppressives and anti-TNF. Patients with intolerance to IS and anti-TNF will also be allowed in the latter group. Participants will be treated with 12 months of open label vedolizumab (study medication followed by commercial medication once reimbursement is available) and undergo monitoring of endoscopic, histological and clinical disease parameters. No...
18 Years - 80 YearsLearn More -
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with moderate to severe Crohn's disease (CD).
18 Years - 65 YearsLearn More -
A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in participants who had a response following induction with ABT-494.
18 Years - 75 YearsLearn More -
A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease
This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn' disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells.
18 Years - 65 YearsLearn More -
A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Ulcerative Colitis
A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.
18 Years - 75 YearsLearn More -
Autologous Adipose-derived Stem Cells (ASCs) for the Treatment of Perianal Fistula in Crohn Disease: A Pilot Study
Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea, respectively. Uncontrolled chronic inflammation finally causes various complications in intestine such as bowel obstruction, fistulas, abscesses, and anal fissures. The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease. Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem after surgical...
18 Years and OverLearn More -
Autologous Stem Cell Transplantation for Crohn's Disease
The objective of this study is to evaluate the safety and effectiveness of administering high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC) in pediatric and adult patients with severe Crohn's disease.
10 Years - 60 YearsLearn More -
Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease
This study evaluates the safety and clinical benefits of a therapeutics approach of conditioning regimen Cyclophosphamide (Cy) + Thymoglobulin r (ATG) + Granulocyte Colony-Stimulating Factor (G-CSF) followed by autologous Hematopoietic Stem Cell Transplantaion (HSCT) rescue in therapy refractory Crohn's disease. It will be counted adverse events, clinical and endoscopic condition at various short and long-term time points.
14 Years - 70 YearsLearn More
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