A Study of Budesonide Suspension in Adolescents and Adults with Eosinophilic Esophagitis Measuring Histologic Response and Decreased Dysphagia

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-007230
    NCT ID: NCT02605837
    Sponsor Protocol Number: SHP621-301

About this study

A study of the effectiveness of oral Budesonide suspension in adolescents and adults with eosinophilic esophagitis measuring the histologic response and determining if any decrease in difficult swallowing is achieved.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Able to provide written informed consent to participate in the study
  • Has histologic evidence of Eosinophilic Esophagitis with a peak eosinophil count of ≥15/HPF, from 2 of 3 (proximal, mid-, and/or distal) levels of the esophagus at the screening endoscopy
  • Has a history of clinical symptoms of esophageal dysfunction (eg, eating problems, abdominal pain, heartburn, dysphagia, vomiting, food impaction, weight loss) intermittently or continuously at screening (visit -1)
  • Must have experienced dysphagia (response of "yes" to question 2 on DSQ) on a minimum of 4 days and completed the DSQ on ≥70% of days in any 2 consecutive weeks of the screening period and in the 2 weeks prior to the baseline visit (visit 1)
  • Must not have proton pump inhibitor responsive EoE based on esophageal biopsies performed after the patient has been on at least 8 weeks of high-dose PPI therapy
    • High-dose therapy refers to the total daily dose, which may have been administered as a once- or twice daily dosing regimen
    • This may occur at the time of the qualifying esophagogastroduodenoscopy (EGD) in which case the same PPI regimen must be continued
    • Or this may have been done previously in which case PPI therapy may have been stopped if there was no response to therapy based on esophageal biopsy results
  • Will be on a stable (no changes) diet ≥3 months prior to the screening visit (visit 1)
  • Willing and able to continue any dietary therapy, environmental therapy, and/or medical regimens including gastric acid suppression (see exclusions below) in effect at the screening visit (visit -1)
    • There should be no change to these regimens during study participation
  • All female subjects must have a negative serum pregnancy test prior to enrollment into the study
  • Females of childbearing potential must agree to continue acceptable birth control measures (eg, abstinence, surgically sterile male partner, stable oral contraceptives, or double-barrier methods) throughout study participation
  • Willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol

Exclusion Criteria

  • Has any condition or abnormality that would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of EoE
  • Has used immunomodulatory therapy within 8 weeks prior to the qualifying EGD or between the qualifying EGD and baseline visit
  • Has been using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition within the 4 weeks prior to the qualifying EGD, or anticipates use during the treatment period
  • Has been on inhaled or intranasal steroids and not on stable treatment for greater than 3 months prior to screening visit
  • Has initiated, discontinued, or changed dosage regimen of PPIs, H2 antagonists, antacids, antihistamines, or leukotriene inhibitors for any condition
  • Has been using cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice) within the 2 weeks prior to the baseline visit, or anticipates using such medications during the treatment period
  • Has an appearance on qualifying EGD of an esophageal stricture, as defined by the presence of a lesion that does not allow passage of a diagnostic adult upper endoscope
  • Is on a pure liquid diet or the 6-food elimination diet
  • Has had an esophageal dilation within the 3 months prior to screening
  • Has presence of esophageal varices at the screening endoscopy
  • Has any current disease of the GI tract, aside from EoE, including eosinophilic gastritis, enteritis, colitis, or proctitis; inflammatory bowel disease; or celiac disease
  • Has other diseases causing or associated with EoE, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection
  • Has current evidence of oropharyngeal or esophageal candidiasis
  • Has acute or chronic viral infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, herpes esophagitis, or chicken pox/measles.
  • Has upper GI bleeding within 4 weeks prior to the screening visit (visit -1)
  • Has evidence of active infection with Helicobacter pylori
  • Has evidence of unstable asthma within 4 weeks prior to the screening visit
  • Is female and pregnant or nursing
  • Has a history of intolerance, hypersensitivity, or idiosyncratic reaction to budesonide (or any other corticosteroids)
  • Has taken part and received intervention in an investigational study within 6 months prior to the screening visit or subject has participated in a previous clinical study involving OBS (SHP621)
  • Has a history or high risk of noncompliance with treatment or regular clinic visits
  • Has previously completed, discontinued, or withdrawn from this study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Katzka, M.D.

Open for enrollment

Contact information:

Debra Geno CCRP

(507)538-0367

Geno.Debra@mayo.edu

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CLS-20271278

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