Study of BLU-808 in Allergic Rhinoconjunctivitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2025-09-08

Brief Summary

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This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of BLU-808 in participants with ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). Participants will undergo eligibility assessments that include exposure to ragweed pollen in an allergen exposure chamber (AEC).

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Detailed Description

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Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BLU-808 Dose 1

BLU-808 will be administered orally for 28 days.

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

BLU-808 tablets

BLU-808 Dose 2

BLU-808 will be administered orally for 28 days.

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

BLU-808 tablets

Placebo

Placebo will be administered orally for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Interventions

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BLU-808

BLU-808 tablets

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults, 18 years of age or older, willing to provide written informed consent, and willing to comply with all study requirements.
2. History (\>2 years) of ragweed-induced ARC.
3. A positive ragweed skin prick test (mean diameter of ≥ 5 mm) in the last 6 months.
4. Must meet clinically relevant nasal and ocular symptoms as defined by the protocol.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria are met:

1. Receiving medications (oral, nasal, topical, ocular, or injectable) to treat their ragweed or other allergy symptoms and/or receiving any medications that impact participants' safety or interfere with study assessments or interpretation of study results.
2. Have active rhinitis, sinusitis, and/or other severe allergies not associated with the ragweed pollen that may interfere with study symptom assessments.
3. Any prior or ongoing clinically significant illness, medical or psychiatric condition, surgical history, or physical finding that may interfere with the assessment or interpretation of study results.
4. Clinically significant moderate to severe, uncontrolled cardiovascular, renal or hepatic disease.
5. Significant bleeding risk or coagulation disorders.
6. Any form of smoking, vaping or history of alcohol and drug abuse.
7. Any malignancy within the past 5 years prior to Screening/AEC 1, except for basal cell or squamous cell carcinomas of the skin or carcinoma in situ.
8. Inadequately controlled asthma that could affect the safety of the participant or interfere with the assessment or interpretation of study results.
9. Known active/latent infection (viral, bacterial, fungal, helminth, or mycobacterial) such as tuberculosis, hepatitis B, hepatitis C, AIDS-related illness, or COVID-19 infection.
10. History of sinonasal conditions that may confound the assessment or interpretation of study results.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No