NCT07556393
Completed
Phase 2
A Randomized, Double-blind, Placebo-controlled, Environmental Exposure Unit Trial of Intranasal INI-2004 in Subjects With Ragweed-induced Allergic Rhinitis
Inimmune Corporation1 site in 1 country78 target enrollmentStarted: January 19, 2026Last updated:
DrugsINI-2004
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Inimmune Corporation
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Assessment of incidence, severity and relationship of treatment-emergent adverse events (TEAEs), leading to discontinuation of study treatment
Overview
Brief Summary
The purpose of this trial is to see how well an experimental nasal spray, called INI-2004, works for those with allergy symptoms to ragweed. This nasal spray will compare how well 500mcg of INI-2004, given once per week for 4 weeks, works at reducing ragweed allergy symptoms in an Environmental Exposure Unit (EEU), compared to placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must have given valid written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •Healthy male or female, aged between 18 and 64 years, inclusive at screening.
- •Minimum 12-month history of ragweed-induced AR requiring pharmacotherapy (self-reported history accepted), history of or current positive ragweed skin prick test reaction (≥ 5mm greater than the diluent) at SV1, and a TNSS score of ≥ 6 at 2 timepoints during the SV2 ragweed allergen EEU challenge, including a "congestion" score of ≥ 2 at ≥ 1 time point.
- •Body mass index (BMI) of 17 to 39 kg/m2, inclusive, at screening. Subjects with BMI \> 39 kg/m2 may be included with permission of the Sponsor.
- •Participant is medically healthy (in the opinion of the PI \[or delegate\]), as determined by medical history and without clinically significant abnormalities including:
- •Physical examination without any additional clinically relevant findings
- •Vital signs (pulse, blood pressure, respiratory rate, temperature) without clinically significant abnormalities, in the opinion of the PI (or delegate).
- •Electrocardiogram without clinically significant abnormality at screening including QT interval corrected for Fredericia (QTcF) ≤ 450 msec for male subjects and ≤ 470 msec for female subjects. The ECG may be repeated if technically unsatisfactory (e.g. artifact) or otherwise thought not to be representative, at the discretion of the Investigator.
- •No clinically significant findings in serum chemistry, hematology or urinalysis as judged by the PI (or delegate).
- •Female participants must be of non-child-bearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or, if of child-bearing potential\*:
Exclusion Criteria
- •Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
- •History of perennial allergic rhinitis which may confound study results.
- •Ragweed targeted allergy immunotherapy within five years of screening.
- •Expected travel to an area with potential environmental ragweed exposure within 7 days of SV2 through Day
- •History of any clinically relevant or unstable disorder which, in the opinion of the PI (or delegate) would make implementation of the protocol or interpretation of study results difficult, or that would put the subject at risk by participating in the study, including uncontrolled cardiovascular, hematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, immunologic, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic, and psychiatric diseases. Note: a history of fully resolved childhood asthma is not exclusionary; history of cholecystectomy is not exclusionary; history of anxiety and/or depression is permitted provided symptoms are controlled on or off approved concomitant medication for at least 6 months prior to SV
- •Local malignancies with complete surgical resection (e.g. basal cell carcinoma, cervical cancer-in-situ) are not exclusionary.
- •Asthma that requires regular pharmacotherapy, is expected to require regular pharmacotherapy during study participation, or that is expected to be exacerbated by ragweed EEU challenge. Note: PRN pharmacotherapy for asthma is permitted, as long as there has been no use within 14 days prior to the first dose of study drug on Day
- •Participants must refrain from use during the study, unless medically necessary.
- •Currently experiencing symptomatic perennial rhinitis requiring medication as per PI (or delegate) judgement.
- •Use of oral or systemic steroids within 28 days of SV2, oral anti-histamines within 14 days of SV2, and intranasal medications, or any prescription or over-the-counter medication within 7 days prior to SV2 or expected use during study conduct from 7 days before Day 0 through Day 38, that would affect TNSS scores, in the opinion of the PI (or delegate). Topical steroids are allowable.
Arms & Interventions
Subjects receive dose of placebo
Placebo Comparator
Administered as four weekly intranasal doses
Intervention: Placebo (Other)
Subjects receive a 500 μg dose of INI-2004
Active Comparator
Administered as four weekly intranasal doses
Intervention: INI-2004 (Drug)
Outcomes
Primary Outcomes
Assessment of incidence, severity and relationship of treatment-emergent adverse events (TEAEs), leading to discontinuation of study treatment
Time Frame: Baseline (SV2) vs Day 24
Assessment of adverse events (AEs) to determine the safety and tolerability of INI-2004 following four weekly doses
Calculate the change from baseline (SV2) vs D24 in Total Nasal Symptom Score (TNSS) during the chamber exposure (AUC0-180) for all subjects
Time Frame: Baseline (SV2) vs Day 24
To evaluate the efficacy of INI-2004 compared with placebo by assessing change in the Area Under the Curve (AUC) of the Total Nasal Symptom Score (TNSS)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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