RECRUITING

A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults with Eosinophilic Esophagitis

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Conditions

Eosinophilic Esophagitis (EoE)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.

Official Title

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study with an Open Label Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults with Eosinophilic Esophagitis (ALAMERE)

Quick Facts

Study Start:2024-10-16
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06598462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Uniquity One
CONTACT
484-267-2500
ClinicalTrials@uniquity.com

Principal Investigator

Andrew W Lee, MD
STUDY_CHAIR
Vice President, Clinical Research

Study Locations (Sites)

Research Site 1039
Dothan, Alabama, 36305
United States
Research Site 1015
San Diego, California, 92120
United States
Research Site 1040
Inverness, Florida, 34452
United States
Research Site 1001
Jacksonville, Florida, 32256
United States
Research Site 1004
Boston, Massachusetts, 02111
United States
Research Site 1006
Plymouth, Minnesota, 55446
United States
Research Site 1016
Reno, Nevada, 89511
United States
Research Site 1020
Harrisburg, Pennsylvania, 17110
United States
Research Site 1002
Ogden, Utah, 84405
United States
Research Site 1017
Sandy, Utah, 84092
United States

Collaborators and Investigators

Sponsor: Uniquity One (UNI)

  • Andrew W Lee, MD, STUDY_CHAIR, Vice President, Clinical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-16
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-10-16
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Eosinophilic Esophagitis (EoE)