Clinical trials: Inflammatory Bowel System
Ulcerative Colitis, Crohn's Disease
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
- Trial name
- GEMINI LTS (NCT00790933)
- Testing
- Vedolizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 2,243 people
- Sponsor
- Takeda
Ulcerative Colitis
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02895100
- Testing
- PTG-100
- Where
- 98 sites in United States, Australia and 15 more
- Volunteers
- 98 people
- Sponsor
- Protagonist Therapeutics, Inc.
Ulcerative Colitis
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
- Trial name
- Touchstone (NCT01647516)
- Testing
- Ozanimod
- Where
- 88 sites in United States, Australia and 13 more
- Volunteers
- 199 people
- Sponsor
- Celgene
Ulcerative Colitis
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over…
- Trial name
- CAPYBARA (NCT05479058)
- Testing
- Filgotinib
- Where
- 50 sites in United States, Belgium and 11 more
- Volunteers
- 22 people
- Sponsor
- Lakefront Biotherapeutics NV
Ulcerative Colitis
HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis
A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy…
- Trial name
- NATRUL-4 (NCT01882764)
- Testing
- HMPL-004
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Hutchison Medipharma Limited
Ulcerative Colitis (UC)
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis…
- Trial name
- U-Accomplish (NCT03653026)
- Testing
- Upadacitinib
- Where
- 379 sites in United States, Argentina and 42 more
- Volunteers
- 522 people
- Sponsor
- AbbVie
Crohn's Disease
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol…
- Trial name
- NCT00195715
- Testing
- Adalimumab
- Where
- 111 sites in United States, Australia and 13 more
- Volunteers
- 777 people
- Sponsor
- Abbott
Crohn Disease
Crohn's Allogeneic Transplant Study
This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in treating patients with refractory Crohn's Disease.
- Trial name
- CATS (NCT01570348)
- Testing
- Allogeneic Bone Marrow Transplantation, Cyclophosphamide, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Fred Hutchinson Cancer Center
Crohn Disease
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's…
- Trial name
- NCT00094458
- Testing
- infliximab (IFX) infusion; azathioprine (AZA) caps
- Where
- 115 sites in United States, Austria and 13 more
- Volunteers
- 508 people
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
Ulcerative Colitis, IBD
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by…
- Trial name
- Expedition (NCT03616821)
- Testing
- Brazikumab
- Where
- 125 sites in United States, Canada and 17 more
- Volunteers
- 242 people
- Sponsor
- AstraZeneca
Crohn Disease
Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.
- Trial name
- BLINK (NCT03241368)
- Testing
- Capsule Endoscopy
- Where
- 26 sites in United States, Austria and 1 more
- Volunteers
- 187 people
- Sponsor
- Medtronic - MITG
Inflammatory Bowel Diseases
Assessment of Colonic Epithelial Integrity With Mucosal Impedance
In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity changes in the colonic epithelium.
- Trial name
- NCT03165058
- Testing
- mucosal impedance (MI) testing
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Vanderbilt University Medical Center
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
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis…
- Trial name
- OCTAVE (NCT01465763)
- Testing
- tofacitinib
- Where
- 178 sites in United States, Australia and 26 more
- Volunteers
- 614 people
- Sponsor
- Pfizer
Ulcerative Colitis
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT02531126
- Testing
- RPC1063
- Where
- 41 sites in United States, Australia and 18 more
- Volunteers
- 877 people
- Sponsor
- Celgene
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
Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.
This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in…
- Trial name
- NCT02031276
- Testing
- risankizumab IV, risankizumab SC
- Volunteers
- 121 people
- Sponsor
- AbbVie
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.
- Trial name
- NCT01671956
- Testing
- Bertilimumab
- Where
- 6 sites in Israel
- Volunteers
- 32 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Ulcerative Colitis
Low Dose IL-2 for Ulcerative Colitis
The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.
- Trial name
- NCT02200445
- Testing
- Interleukin-2 (aldesleukin).
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Scott B. Snapper, MD PHD
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer