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Eosinophilic Disorders


A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis

This study is being conducted to test the efficacy and safety of AK002 in patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis and requires nine study visits over the course of 24 weeks. Participants will receive study drug or placebo via infusion during four of these visits. 

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FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo- controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis 

FLUTE is a randomized, double-blind, placebo-controlled dose-ranging study of 4 total dailydoses of APT-1011 versus placebo in 100 adult subjects (at least 18 years of age) diagnosed with EoE. During the single-blind run-in/baseline symptom assessment, the subjects will receive placebo 30 minutes after breakfast and HS (at bedtime). APT-1011 will be administered in 4 doses: Placebo 30 minutes after breakfast and 1.5 mg HS (at bedtime), 1.5 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 3 mg), 3 mg HS (at bedtime), and 3 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 6 mg), compared with matching placebo administered 30 minutes after breakfast and HS (at bedtime). The randomization scheme is discussed in Section 4.1.5.2. Efficacy (histological response), safety, and PK of APT-1011 will be examined. 
FLUTE will enroll around 100 adult (at least 18 years of age) subjects (see Section 8.1 for a discussion of the potential number of subjects to participate in each part). 
FLUTE is planned to be performed at approximately 60 active sites in North America (US and Canada) and Western Europe (Belgium, Germany and Spain). The study will be conducted in several parts (Screening, 4-week single-blind placebo run-in and Baseline Symptom Assessment, and 2 treatment parts [Part 1 and Part 21) with a Follow-up Visit to occur 2 weeks after the final dose of study drug. Subjects who enter and complete FLUTE will be in the study for up to 62 weeks until the last subject completes Week 28. 

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Eosinophilic Esophagitis


Development, Validation, and Evaluation of an Adult and Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study

Eosinophilic Esophagitis (EoE) is a swallowing disorder which is caused by an allergy-like inflammation of the esophagus. It is diagnosed by esophageal biopsies and can be treated with anti-inflammatory medicines. There are cases of EoE in children and adults and the symptoms primarily present with difficulty swallowing or the feeling of food being stuck in the esophagus. Currently there is no exact way to define the activity of Eosinophilic Esophagitis. An activity index for measuring the disease severity has not been developed so there is difficulty in measuring the treatment responses in clinical studies. The creation of an Activity Index (or a score) for EoE will allow the objective measurement of patient symptoms.

The aim of the current multi-center study is to develop, validate and evaluate an EoE activity index for pediatric and adult patients. Our site at Tufts will soley be involved in the adult population of patients with EoE. The study is purely observational and involves undergoing a structured interview from the research coordinator involved in the study in addition to the standard medical care (including medicines, endoscopic evaluations and biopsies, for example) by one of the investigators of the study. There is also a questionnaire that the patients will have to fill out. There are several items in the questionnaire measuring the symptoms (eg frequency of dysphagia, dysphagia in relation to distinct food consistencies). There is also a component where the biologic activity (number of eosinophils in esophageal biopsy or presence of signs of acute inflammation in esophagoscopy) will be incorporated. The biologic activity component will be completed by the principal or co-investigators who are caring for the patients.

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FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo- controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis 

FLUTE is a randomized, double-blind, placebo-controlled dose-ranging study of 4 total dailydoses of APT-1011 versus placebo in 100 adult subjects (at least 18 years of age) diagnosed with EoE. During the single-blind run-in/baseline symptom assessment, the subjects will receive placebo 30 minutes after breakfast and HS (at bedtime). APT-1011 will be administered in 4 doses: Placebo 30 minutes after breakfast and 1.5 mg HS (at bedtime), 1.5 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 3 mg), 3 mg HS (at bedtime), and 3 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 6 mg), compared with matching placebo administered 30 minutes after breakfast and HS (at bedtime). The randomization scheme is discussed in Section 4.1.5.2. Efficacy (histological response), safety, and PK of APT-1011 will be examined. 
FLUTE will enroll around 100 adult (at least 18 years of age) subjects (see Section 8.1 for a discussion of the potential number of subjects to participate in each part). 
FLUTE is planned to be performed at approximately 60 active sites in North America (US and Canada) and Western Europe (Belgium, Germany and Spain). The study will be conducted in several parts (Screening, 4-week single-blind placebo run-in and Baseline Symptom Assessment, and 2 treatment parts [Part 1 and Part 21) with a Follow-up Visit to occur 2 weeks after the final dose of study drug. Subjects who enter and complete FLUTE will be in the study for up to 62 weeks until the last subject completes Week 28. 

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Inflammatory Bowel Disease


Metabolic Signature of Colonic Migcroorganisms in Inflammatory Bowel Disease

Characterization of anaerobic microorganisms in the bowel of patients with inflammatory bowel disease.

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