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A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients with Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) (ENIGMA)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).
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A Phase 3, Multi-center, Multi-national, Randomized, Double-blind, Placebo-controlled, Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis (CC-93538-EE-001)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purposes of this study are to assess the effectiveness of CC-93538 versus placebo in reducing dysphagia symptoms at 24 weeks, and to assess the effectiveness of CC-93538 versus placebo in reducing esophageal eosinophil counts at 24 weeks.
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A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) (AK002-016X)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to generate open-label, longer-term safety, tolerability, and effectiveness follow-up data in patients with EG and/or EoD who completed Study AK002-016 or Study AK002-012.
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effectiveness and safety of 4 doses of AK002 in patients with moderate to severe EG and/or EGE when compared to placebo.
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Use of Mucosal Impedance in Evaluation of Gastroesophageal Reflux Disease
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the accuracy of balloon catheter based mucosal impedance for the diagnosis of GERD in patients who have undergone Peroral Endoscopic Myotomy (POEM).
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