Allergic Rhinitis Due to AllergensPhase 2NCT07556393

Environmental Exposure Unit Trial in Subjects With Ragweed-induced Allergic Rhinitis

A Phase 2 study testing INI-2004 in people with Allergic Rhinitis Due to Allergens and Rhinitis Allergic, run by Inimmune Corporation at 1 site in Canada.

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

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)… Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Allergic Rhinitis Due to Allergens, Rhinitis Allergic, Allergic Rhinitis
What is being tested?: INI-2004
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 1 siteCanada
Study dates: 19 Jan 2026to 23 Apr 2026
Phase: Phase 2

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

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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*:
Must have a negative serum pregnancy test at the screening visit 1, and a negative urine pregnancy test at screening visit 2 and prior to all dose and EEU exposure visits.
Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the last dose of study drug.
If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception (See Appendix 2) from one month prior to dose administration until at least 30 days after the last dose of study drug).
Women who have been surgically sterilized through tubal ligation are permitted to participate, if they agree to use an additional barrier method of contraception from one month prior to the first dose of study drug, until at least 30 days after the last dose of study drug.
Male participants must:
Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom plus a highly effective method of contraception from the time of signing consent until at least 90 days after the last dose of study drug).
Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.

Who cannot join

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 38.
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 SV1. 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 0. Participants must refrain from use during the study, unless medically necessary.

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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.
Any clinically relevant structural nasal abnormalities that may affect distribution of study drug in the nasopharynx i.e., nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds. Note: fully resolved abnormalities/malformations (e.g., via rhinoplasty) are permitted.
Upper respiratory tract infection or upper respiratory tract infection symptoms at SV2 that in the opinion of the PI (or delegate) affect TNSS score and/or other patients' safety.
Other active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of study drug (Day 0), unless such treatment will not interfere with the objectives of the study, in the opinion of the PI (or delegate) and with Sponsor approval.
Concurrent enrolment in another clinical study, or participation in another clinical study within 30 days prior to the first dose of study drug on Day 0.
Regular consumption of >14 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], 30 mL spirit [40% Alc/Vol]).
History of opioid abuse within 3 months of Screening, or the requirement for daily use of opioids for more than 7 days within one month of Screening. Definition of abuse will be as per PI or delegate's judgement.
Current history of drug abuse. Note: UDS testing at SV1 with positive results that result from prescription products used appropriately, that do not represent a history of abuse, are not exclusionary. Repeat assessment is permitted at the discretion of the PI (or delegate) in the instance of positive results. "False positive" results from acceptable products may be disregarded at the discretion of the PI (or delegate). At the discretion of the PI (or delegate), a positive result for delta-9-tetrahydrocannabinol (THC) may not be exclusionary, however participants are not permitted to use combustible or other cannabinoid products within 24 hours prior to each visit SV2 through Day 38
Current use of combustible or chewed tobacco products greater than the equivalent of 10 cigarettes per day, or unwilling to comply with restriction or abstention from all tobacco products 12 hours before each dose of study drug and each EEU session.
Participant is breastfeeding or pregnant or planning to breastfeed or become pregnant during the study.
Known substance abuse or medical, psychological, or social conditions that, in the opinion of the PI (or delegate), may interfere with the participants inclusion in the clinical study or evaluation of the clinical study results.
History of or current infection with Hepatitis B, Hepatitis C, or HIV.
Participant has donated blood or blood products within the following timeframe prior to first dose administration (Day 0):
Blood = 60 days; plasma = 14 days
Participant plans to travel to an area with known environmental ragweed exposures at any time during study participation (from SV1 through to Day 38).
Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Kingston Health Sciences Centre- KGH site
Kingston, Ontario, K7L2V7

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Environmental Exposure Unit Trial of Intranasal INI-2004 in Subjects With Ragweed-induced Allergic Rhinitis

Conditions: Allergic Rhinitis Due to Allergens, Rhinitis Allergic, Allergic Rhinitis
Being tested: INI-2004, Placebo
Keywords: Ragweed, Allergic, Rhinitis
Medical subject headings: Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Rhinitis

What participants receive

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

INI-2004Drug
Toll-like receptor [TLR]4 agonist liposomal formulation
PlaceboOther
Placebo

Study groups in NCT07556393
Study group	Role	What they receive
Subjects receive a 500 μg dose of INI-2004	Active comparator	Administered as four weekly intranasal doses Receives: Drug: INI-2004
Subjects receive dose of placebo	Placebo comparator	Administered as four weekly intranasal doses Receives: Other: Placebo

What is being measured

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

Assessment of incidence, severity and relationship of treatment-emergent adverse events (TEAEs), leading to discontinuation of study treatment
Assessment of adverse events (AEs) to determine the safety and tolerability of INI-2004 following four weekly doses
Measured: Baseline (SV2) vs Day 24
Calculate the change from baseline (SV2) vs D24 in Total Nasal Symptom Score (TNSS) during the chamber exposure (AUC0-180) for all subjects
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)
Measured: Baseline (SV2) vs Day 24

Timeline

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

19 Jan 202623 Apr 2026

First posted29 Apr 2026
Study start19 Jan 2026
Primary completion23 Apr 2026
Study completion23 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Allergic Rhinitis Due to AllergensStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07556393
Sponsor's protocol ID: INI-2004-102
Status last verified: Apr 2026
First submitted: 15 Jan 2026
Last updated: 29 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No