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

PHASE2RECRUITING

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

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Study details:

This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with EoE. Approximately 157 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period.

The study also includes a post-treatment follow-up period of 16 weeks.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

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).

Exclusion criteria

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-16

Primary completion: 2027-04-30

Study completion finish: 2027-08-31

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06598462

Intervention or treatment

DRUG: Solrikitug Low Dose

DRUG: Solrikitug Mid Dose

DRUG: Solrikitug High Dose

OTHER: Placebo

Conditions

• Eosinophilic Esophagitis (EoE)

Image related to Eosinophilic Esophagitis (EoE)

Condition: Eosinophilic Esophagitis (EoE)
DRUG: Solrikitug Low Dose and other drugs
New Castle, North South Wales, Australia and more
Sponsor: Uniquity One (UNI)

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Research Site 1108

Research sites nearby

Select from list below to view details:

Research Site 1108
New Castle, North South Wales, Australia
Research Site 1103
South Brisbane, Queensland, Australia
Research Site 1102
Fitzroy, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Solrikitug low dose Solrikitug	DRUG: Solrikitug Low Dose Solrikitug low dose subcutaneous injection
EXPERIMENTAL: Solrikitug mid dose Solrikitug	DRUG: Solrikitug Mid Dose Solrikitug mid dose subcutaneous injection
EXPERIMENTAL: Solrikitug high dose Solrikitug	DRUG: Solrikitug High Dose Solrikitug high dose subcutaneous injection
PLACEBO_COMPARATOR: Placebo Placebo	OTHER: Placebo Placebo subcutaneous injection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Histological response of peak esophageal eosinophil per HPF count of ≤6	Not Specified	Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score	The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.	Week 24

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Adverse events (AEs) and serious adverse events (SAEs)	Not Specified	To Week 24

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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