An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Recruiting
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
Gender:
All
Ages:
Between 16 years and 80 years
Trial Updated:
10/30/2023
Locations: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
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: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Conditions: Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Recruiting
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whiche... Read More
Gender:
All
Ages:
Between 12 years and 17 years
Trial Updated:
10/05/2023
Locations: Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
Conditions: Ulcerative 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: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
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: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Conditions: Ulcerative Colitis
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Recruiting
The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis [UC]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
01/09/2023
Locations: Dartmouth Hitchcock, Lebanon, New Hampshire
Conditions: Ulcerative Colitis, Crohn Disease