Clinical research study for people with moderate to severe Eosinophilic Duodenitis (EOD)

  • STATUS
    Recruiting
  • sponsor
    Allakos
Updated on 29 July 2021

Summary

A research study is being conducted to evaluate the efficacy and safety of AK002 in patients with moderate to severe active eosinophilic duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies. Patients will be randomly assigned either the study drug or placebo.

Description

Currently there are no approved therapies for patients with this chronic and debilitating disease with reported symptoms ranging from severe abdominal pain, nausea, bloating, early satiety, loss of appetite, abdominal cramping, vomiting, diarrhea, and weight loss. The study drug, AK002, has been shown to reduce the number of blood and tissue eosinophils and inhibiting the activation of masts cells both known to be contributors to EoD.

Study Duration: Subjects will undergo a screening period of up to 45 days, a treatment period of 20 weeks and a follow up period of 12 weeks. For a total of 13 visits.

Eligible subjects may have an option to participate in the Open Label Extension portion of the study, for additional 24 weeks and 8 weeks of follow up. These subjects will have a total of 18 visits.

Study Procedures: Include physical exams with the study doctors, laboratory assessments/blood draws, EGD an colonoscopy, pregnancy tests, ECGs, and symptom tracking with an electronic diary.

Stipend: A stipend will be provided to qualified study participants for time and travel costs. Stipends are paid on a periodic basis as specifically outlined in the subject information and consent form.

Details
Condition Gastrointestinal Diseases and Disorders
Clinical Study IdentifierTX278353
SponsorAllakos
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others
Compliance with completion of daily electronic questionnaires
Female patients must be either post-menopausal for at least 1 year, or surgically sterile for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer
Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer

Exclusion Criteria

Active Helicobacter pylori infection, unless treated and confirmed to be negative by repeat EGD prior to randomization and symptoms remain consistent
History of inflammatory bowel disease, other chronic inflammatory diseases in the colon (with the exception of eosinophilic colitis), celiac disease, achalasia, or esophageal surgery
History of bleeding disorders and/or esophageal varices
Females who are pregnant, lactating or planning to become pregnant before the end of the study or 120 days after the last dose whichever is longer
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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