An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03029091
• Date of registration: 20/01/2017
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
• Scientific title: A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder
• Date of first enrolment: May 23, 2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03029091
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Marc E Rothenberg, MD, PhD
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent/assent

- Confirmed, active EoE (at Screening or within 12 weeks prior to enrollment)

- Does or does not have diagnosis of a connective tissue disorder (CTD)

- Has been on a high dose of proton pump inhibitor (PPI) for at least 8 weeks prior to a
diagnostic endoscopy of EoE without histologic resolution (i.e., = 15
eosinophils/HPF).

- Maintain the same diet, swallowed steroid and PPI therapies throughout the duration of
the study

- Female participants must be either:

1. Of non-childbearing potential (pre-menarchal or surgically sterile with
documentation). OR

2. Have a negative urine pregnancy test at screening and at each monthly study
visit.

Exclusion Criteria:

- Any past or planned cardiac surgery.

- An aortic root Z-score = 3.0 on a previous echocardiogram.

- Intolerance to Losartan

- A mean blood pressure measurement (both systolic and diastolic) at screening that is
below the 2nd percentile for his/her age

- Renal dysfunction

- Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic
syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).

- A diagnosis of hepatic insufficiency (e.g., liver failure, history of liver
transplantation or persistent liver transaminase elevation).

- A history of abnormal gastric or duodenal biopsy or documented gastrointestinal
disorders (e.g., Celiac Disease, Crohn's disease or Helicobacter pylori infection),
not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other
eosinophilic gastrointestinal disorders (EGIDs).

- Use of anti-immunoglobulin (Ig)E monoclonal antibody (mAb), anti-tumor necrosis factor
(TNF) mAb, anti-IL-5 agents, or anti-IL-13 within 6 months prior to study entry

- Use of methotrexate, cyclosporine, interferon a, or other systemic immunosuppressive
or immunomodulating agents within 3 months prior to the screening visit.

- A stricture during endoscopy procedure that prevents passage of the endoscope

- Taking or is planning to take an angiotensin receptor blocker (ARB),
angiotensin-converting enzyme inhibitor (ACEI), beta blocker (BB), or calcium-channel
blocker therapy at the screening visit or at any time during the study or has been
taking any of these medications for 3 months prior to the screening visit.

- Taking or planning to take hydrochlorothiazide, digoxin, warfarin, cimetidine,
phenobarbital, rifampin, or fluconazole.

- Taking or planning to take potassium supplements or salt substitutes containing
potassium.

- A female participant who is pregnant or nursing or, if of childbearing potential, is
not using a medically accepted, effective method of birth control (e.g., condom,
oral/injectable/subcutaneous contraceptive, intrauterine device, or sexual
abstinence).

- Participated/participating in any investigative drug or device study within 30 days
prior to study entry.

- Participated/participating in any investigative biologics study within 3 months prior
to study entry.

- Unable to be confirmed, active EoE (at Screening or within 12 weeks prior to
enrollment)



Age minimum: 5 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Losartan Potassium

Primary Outcome(s)

Number of Serious and Grade 3 or Higher Adverse Events [Time Frame: 20 weeks after the start of treatment (16 weeks treatment and 4 weeks follow-up)]

Change From Baseline in Peak Eosinophil Count [Time Frame: Baseline, 16 weeks]

Secondary Outcome(s)

Change From Baseline in PEESS V2.0 [Time Frame: Baseline,16 weeks]

Change From Baseline in Total Endoscopic Reference Score [Time Frame: Baseline, 16 weeks]

Change From Baseline in Total Histology Scoring System [Time Frame: Baseline, 16 weeks]

Percent of Participants in Complete and Partial Histologic Remission at 16 Weeks [Time Frame: 16 weeks]

Change From Baseline in PedsQL EoE [Time Frame: Baseline, 16 weeks]

Secondary ID(s)

U54AI117804

2015-9021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Advancing Translational Science (NCATS)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Allergy and Infectious Diseases (NIAID)

Office of Rare Diseases (ORD)

Results

• Results available: Yes
• Date Posted: 10/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03029091