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A Phase 2a Multicenter, Randomized, Platform Study Of Targeted Therapies For The Treatment Of Adult Subjects With Moderate To Severe Crohn's Disease
Rochester, MN
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
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Endoscopic sleeve gastroplasty (ESG) as a treatment option for obesity in ulcerative colitis (UC) patients undergoing colectomy with ileal pouch anal anastomosis (IPAA)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of endoscopic sleeve gastroplasty (ESG) for weight loss in a population of obese ulcerative colitis (UC) patients undergoing colectomy with eventual ileal pouch anal anastomosis (IPAA).
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Inflammatory Bowel Disease Treatment And Response To Therapy
Scottsdale/Phoenix, AZ
Rochester, MN
The purpose of this study is to Identify baseline and early treatment genetic, molecular, and cellular drivers of 4-month endoscopic response to anti-IL-23, anti-α4β7, or TNF-cycling among UC and CD patients with secondary loss of response or partial response to a prior anti-TNF.
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Phase 2 Platform Trial To Assess The Efficacy And Safety Of Long-acting Antibodies As Single Agents And In Combinations For Moderately To Severely Active Ulcerative Colitis
Rochester, MN
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
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Closed for Enrollment
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Assessing the Role of a Whole-Food, Plant-Based (WFPB) Diet in the Treatment of Active Crohn’s Disease (WFPB)
Rochester, MN
The overall objective of this proposal is to evaluate the potential therapeutic benefit of a whole-food, plant-based (WFPB) diet in patients with Crohn’s disease (CD). Our hypothesis is that patients adhering to WFPB diet will achieve higher rates of clinical remission and reduction in intestinal inflammation, as compared to controls who will implement FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet. In order to further understand the pathogenesis by which diet may influence CD, we will also plan to study how WFPB may induce changes in the gut microbiota and intestinal permeability. We will test these hypotheses through the following specific aims, which will be conducted in CD patients only (excluding ulcerative colitis or indeterminate colitis), to standardize the underlying disorder.
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