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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06598462




Registration number
NCT06598462
Ethics application status
Date submitted
13/09/2024
Date registered
19/09/2024
Date last updated
12/11/2024

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults with Eosinophilic Esophagitis
Scientific 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)
Secondary ID [1] 0 0
NSI-8226-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis (EoE) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Solrikitug Low Dose
Treatment: Drugs - Solrikitug Mid Dose
Treatment: Drugs - Solrikitug High Dose
Other interventions - Placebo

Experimental: Solrikitug low dose - Solrikitug

Experimental: Solrikitug mid dose - Solrikitug

Experimental: Solrikitug high dose - Solrikitug

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Solrikitug Low Dose
Solrikitug low dose subcutaneous injection

Treatment: Drugs: Solrikitug Mid Dose
Solrikitug mid dose subcutaneous injection

Treatment: Drugs: Solrikitug High Dose
Solrikitug high dose subcutaneous injection

Other interventions: Placebo
Placebo subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Histological response of peak esophageal eosinophil per HPF count of =6
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Adverse events (AEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
To Week 24

Eligibility
Key inclusion criteria
Key inclusion criteria

Part A

* Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
* Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming diagnosis of EoE.
* Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia per week in the 4 weeks prior to Screening.
* Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study.
* May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the Screening and must agree to no changes to background medication or dosage unless medically indicated.
* Discontinuation of any marketed investigational drug or biologic (monoclonal or polyclonal antibody) within 30 days or 5 half-lives prior to screening, whichever is longer.
* Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.

Part B

* Participants who have completed all Part A assessments, doses, and have current negative pregnancy test may have the option to participate in the extension portion of this study (Part B).

Key exclusion criteria

Part A

* Female participant who is pregnant or breastfeeding.
* Have a history or presence of any other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, gastritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
* Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
* Esophageal dilation performed within 8 weeks prior to screening.
* Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.

Part B

* Participants who, during Part A, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present and unreasonable risk to the participant.
* Participants who became pregnant during Part A.
* Participants who are prematurely discontinued from study drug due to AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part B).
* Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
157
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
North South WalesQLD,VIC
Recruitment hospital [1] 0 0
Research Site 1108 - New Castle
Recruitment hospital [2] 0 0
Research Site 1103 - South Brisbane
Recruitment hospital [3] 0 0
Research Site 1102 - Fitzroy
Recruitment postcode(s) [1] 0 0
- New Castle
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Uniquity One (UNI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Trial website
https://clinicaltrials.gov/study/NCT06598462
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew W Lee, MD
Address 0 0
Vice President, Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Uniquity One
Address 0 0
Country 0 0
Phone 0 0
484-267-2500
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06598462