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Eosinophilic EsophagitisPhase 2NCT05757856

A Study to Investigate Safety and Tolerability of NDX-3315 and NDX-3324 in Healthy Participants and Patients With Eosinophilic Esophagitis

A Phase 2 study testing NDX-3315, NDX-3324 and SPECT/CT Imaging in people with Eosinophilic Esophagitis, run by NexEos Diagnostics, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Eosinophilic Esophagitis
What is being tested?
NDX-3315, NDX-3324 and SPECT/CT Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
3 sitesUnited States
Study dates
20 Jan 2023to 22 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Participants:
  • Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) assessment.
  • EoE Participants:
  • Documented diagnosis of EoE (based on prior endoscopy with biopsies showing eosinophils ≥15 / HPF); AND
  • History (by patient report) of recurrent dysphagia and/or other related EoE symptoms (with intake of solids off anti-inflammatory therapy) prior to screening; dysphagia is defined as trouble swallowing solid food, or having solid food stuck, by patient report.

Who cannot join

  • Medical Conditions:
  • Participant with presence of any other disease of the GI tract, including cancer, autoimmune esophageal disease, GERD which is symptomatic or uncontrolled, Barrett's esophagus, eosinophilic gastritis, enteritis, colitis, or proctitis; inflammatory bowel disease; or celiac disease. Known motility disorder of esophagus; achalasia or suspicion thereof.
  • Sleep apnea, if considered by the investigator a concern for the endoscopic procedure.
  • History of recurrent aspiration pneumonia.
  • History of bleeding disorders, liver cirrhosis or esophageal varices.
  • A current malignancy or previous history of cancer in remission for less than 5 years prior to Screening (participants will not be excluded if they had localized carcinoma of the skin that was resected for cure).
Show all 19Show fewer
  • Participant with a Body Mass Index >40 m2/kg or inability to undergo a CT (or SPECT scan) due to weight limitations.
  • Participant is pregnant or nursing.
  • Prior/Concomitant Therapy:
  • Participant who is on anticoagulation therapy that, in the investigator or Medical Monitor's opinion, cannot safely come off medication.
  • Use of chronic aspirin (with the exception of low-dose aspirin as long as the dose remains stable and not increased while on study), nonsteroidal agents, or anti-coagulants within 2 weeks prior to screening.
  • Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 6 weeks prior to Screening visit.
  • Participant is being treated with systemic immunosuppression, carafate (sucralfate), or investigational agent of any kind within less than 3 months or 5 half-lives, whichever is longer, prior to Screening visit (this also includes investigational formulations of marketed products).
  • Diagnostic Assessments:
  • Evidence of clinically significant abnormality in the hematological and biochemical assessments at Screening Visit, specifically: International Normalized Ratio (INR) >1.4; platelet count <80,000/μL and creatinine level >2 mg/dL.
  • ECG: QTcF ≥450 msec for males and QTcF ≥470 msec for females at the time of screening.
  • Other Exclusion Criteria:
  • Any condition that would not permit adequate biopsies of the esophagus (e.g., esophageal varices, significant stricture precluding passage of a 9 mm endoscope, known allergy to sedative used for endoscopy).
  • Healthy Participants Only: A history or current diagnosis of allergic diseases (Should be discussed with Medical Monitor and PI to decide whether exclusionary), autoimmune disease, chronic rhinosinusitis or serum immunoglobulin E (IgE) level ≥100 kU/L. On any medications including NSAIDS and any over the counter (OTC) medications unless it is birth control or acne medications with the exception of Accutane, or if deemed acceptable to use by Medical Monitor and PI.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern Univerisity

    Chicago, Illinois, 60611

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: An Open-label Phase 2 Study Assessing the Safety, Tolerability and Preliminary Diagnostic Performance of a Radioactive Imaging Agent, NDX-3315 and NDX-3324, in Healthy Adult Participants and Patients With Eosinophilic Esophagitis

An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).

Read the detailed description

This study is a multi-site, Phase 2, open-label study of orally administered NDX-3315 or NDX-3324 and esophageal imaging in healthy participants and participants with EoE.

Study details include:

  • The study duration or period will be up to around 10 weeks.
  • Participants will receive either one or two doses of NDX-3315 or NDX-3324 depending on their assigned regimen arm. EoE participants will receive two doses; healthy participants will receive one dose. There will be a SPECT/CT scan performed at each dose.
  • The visit frequency will be three site visits for healthy participants and four site visits for EoE participants followed by one follow-up phone call visit within the study period.
Being tested
NDX-3315, NDX-3324, SPECT/CT Imaging
Keywords
Eosinophilic Esophagitis, EoE, Diagnostic
Medical subject headings
Eosinophilic Esophagitis, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDX-3315Drug

    Oral solution

  • NDX-3324Drug

    Oral solution

  • SPECT/CT ImagingDiagnostic test

    Participants undergo SPECT/CT imaging following administration of NDX-3315 or NDX-3324.

Study groups in NCT05757856
Study groupRoleWhat they receive
Participants Receiving NDX-3315ExperimentalParticipants receive NDX-3315 (delivered via oral syringe at ~ 1.5 mL per minute) using Regimen 5 (5 sips administered over approximately 5 minutes) or Regimen 10 (10 sips administered over approximately 10 minutes), followed by SPECT/CT imaging. Both healthy participants and participants with EoE are included.
Receives: Drug: NDX-3315; Diagnostic Test: SPECT/CT Imaging
Participants Receiving NDX-3324ExperimentalParticipants receive NDX-3324 (delivered via oral syringe at ~ 1.5 mL per minute) using Regimen 10 (10 sips administered over approximately 10 minutes) in a sitting reclined position, followed by SPECT/CT imaging. Both healthy participants and participants with EoE are included.
Receives: Drug: NDX-3324; Diagnostic Test: SPECT/CT Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of all participants with AEs following administration of NDX-3315 and NDX-3324

    An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product and that does not necessarily have causal relationship with this treatment.

    Measured: From start of study drug administration up to End of Study (EOS) ( Up to 3 Weeks)

  2. Peak eosinophil counts per high-power field (HPF)

    A blinded pathologist will perform peak eosinophil counts per high-power field (HPF) on biopsy specimens of the esophagus.

    Measured: Up to 10 days after last dose

  3. Absolute quantification of SPECT imaging

    SPECT images will be analyzed for radioactive per region of interest(ROI) of the esophagus.

    Measured: Up to 45 minutes after dose

  4. Determine Concordance of Outcomes

    Determine concordance rate between

    1. eMBP1 immunostaining score on biopsy specimens (esophagus) and
    2. NDX-3315 and NDX-3324 absolute quantification of SPECT imaging of esophagus

    Measured: Up to 10 Days After Last Dose

Secondary outcomes (6)

  1. Partial Thromboplastin Time (PTT) as marker of pharmacodynamics (PD)

    Blood samples will be collected to measure Partial Thromboplastin Time (PTT), which is a blood test that looks at how long it takes for blood to clot.

    Measured: Baseline, 2 hours post-dose (Up to 1 Week)

  2. Radioactivity of blood collected from participants exposed to NDX-3315 and NDX-3324.

    Blood samples will be collected to measure radioactivity as counts per minute(cpm) and disintegrations per minute(dpm).

    Measured: 2.5 hours post-dose (Up to 1 Week)

  3. Visual ratings of SPECT images

    A blinded central reviewer will review SPECT images for uptake of NDX-3315 or NDX-3324 per region of interest(ROI) of the esophagus using a 5-point scale (0= no uptake to 4 = uptake similar to bowel), with 4 being the worst result.

    Measured: Up to 45 minutes after dose

  4. Deposition of eMBP1

    A blinded immunostaining analyst will perform analysis of deposition of Eosinophil Major Basic Protein 1 (eMBP1) via immunostaining of biopsy specimens of the esophagus.

    Measured: Up to 10 days after last dose

  5. EoE Endoscopic Reference Score (EREFS)

    The EoE-EREFS (Edema, Rings, Furrows, Exudates, Strictures) scores are used to measure the endoscopically identified EoE esophageal mucosal characteristics. The evaluation includes stricture (if applicable); exudates (absent, mild, severe); furrows (absent, present); edema (absent, present); crepe paper esophagus (absent, present), and overall general appearance incorporating all endoscopically-identified EoE findings (e.g., fixed rings, strictures, whitish exudates, furrowing, edema, and crepe paper mucosa). The EoE -EREFS score being used in this study has a range from 0-11, with 11 being the worst result.

    Measured: Up to 10 days after last dose

  6. EoE Symptom Collection Questionnaire

    A questionnaire will be used to collect study participant symptoms such as severity of EoE dysphasia as well as concerns about pain. Answers will have corresponding score ranging from 1-18, with 18 being the worst result.

    Measured: Baseline (All participants), Day 1 (EoE participants only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2023
  2. Study start20 Jan 2023
  3. Primary completion22 May 2025
  4. Study completion22 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants are enrolled into one of two intervention groups. In Arm 1, participants receive NDX-3315 administered orally using Regimen 5 or Regimen 10, followed by SPECT/CT imaging. In Arm 2, participants receive NDX-3324 administered orally using Regimen 10, followed by SPECT/CT imaging. Both healthy participants and participants with EoE are included in both arms.
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05757856
Sponsor's protocol ID
NDX-3315-1001
Status last verified
May 2026
First submitted
10 Feb 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NDX-3315, NDX-3324 and SPECT/CT Imaging in people with Eosinophilic Esophagitis, run by NexEos Diagnostics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of all participants with AEs following administration of NDX-3315 and NDX-3324 (time frame: From start of study drug administration up to End of Study (EOS) ( Up to 3 Weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05757856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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