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

NCT07556393 | Completed Phase 2

• 1 other identifier: INI-2004-102
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to Allergens; Rhinitis Allergic; Allergic Rhinitis

Keywords

Ragweed; Allergic; Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  Baseline (SV2) vs Day 24

Study Arms (2)

Subjects receive a 500 μg dose of INI-2004

ACTIVE COMPARATOR

Administered as four weekly intranasal doses

Drug: INI-2004

Subjects receive dose of placebo

PLACEBO COMPARATOR

Administered as four weekly intranasal doses

Other: Placebo

Interventions

INI-2004 DRUG

Toll-like receptor \[TLR\]4 agonist liposomal formulation

Subjects receive a 500 μg dose of INI-2004

Placebo OTHER

Placebo

Subjects receive dose of placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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\*:
• 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:

You may not qualify if:

• 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.
• 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.
• 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 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.

Sponsors & Collaborators

• Inimmune Corporation: lead
• Rho, Inc.: collaborator

Study Sites (1)

Kingston Health Sciences Centre- KGH site

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: April 29, 2026
• Study Start: January 19, 2026
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CA (1)