Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in... Read More
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
11/22/2023
Locations: Aga Clinical Research Associates LLC, Egg Harbor Township, New Jersey +3 locations
Conditions: Ulcerative Colitis
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Recruiting
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib... Read More
Gender:
All
Ages:
Between 2 years and 17 years
Trial Updated:
11/21/2023
Locations: Atlantic Children's Health-Pediatric Gastroenterology & Nutrition, Morristown, New Jersey +2 locations
Conditions: Ulcerative Colitis
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Recruiting
TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
Gender:
All
Ages:
2 years and above
Trial Updated:
10/27/2023
Locations: Rutgers, Robert Wood Johnson Medical School, New Brunswick, New Jersey
Conditions: Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Recruiting
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
08/30/2023
Locations: AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey
Conditions: Ulcerative Colitis
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
Recruiting
The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
07/25/2023
Locations: Salix Site 002, Freehold, New Jersey
Conditions: Ulcerative Colitis
ABTECT - Maintenance
Recruiting
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
06/28/2023
Locations: AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey +1 locations
Conditions: Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
Recruiting
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
06/27/2023
Locations: AIG Digestive Disease Research, Florham Park, New Jersey
Conditions: Ulcerative Colitis
Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC)
Recruiting
The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
06/06/2023
Locations: Allied Health Clinical Research Organization, LLC - Englewood, Englewood, New Jersey +2 locations
Conditions: Ulcerative Colitis, Ulcerative Colitis Acute, Ulcerative, Ulcerative Colitis Flare
The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
Recruiting
A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.
Gender:
All
Ages:
Between 16 years and 80 years
Trial Updated:
10/12/2021
Locations: Rutgers Robert Wood Johnson Medical School (Adult), New Brunswick, New Jersey +1 locations
Conditions: Crohn Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Diseases