Allergic Rhinoconjunctivitis
Conditions
Keywords
Allergic Rhinoconjunctivitis, Ambrosia Artemisiifolia, BLU-808, Ragweed
Brief summary
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).
Interventions
DRUGBLU-808
BLU-808 tablets
DRUGPlacebo
Placebo tablets
Sponsors
Blueprint Medicines Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Day 1 through Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of BLU-808 | Day 1 to Day 28 |
| Maximum Plasma Concentration (Cmax) of BLU-808 | Day 1 to Day 28 |
| Minimum Plasma Concentration (Cmin) of BLU-808 | Day 1 to Day 28 |
| Apparent Clearance (CL/F) of BLU-808 | Day 1 to Day 28 |
| Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808 | Day 1 to Day 28 |
| Terminal Half-life (t½) of BLU-808 | Day 1 to Day 28 |
| Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS) | Baseline, Day 14, Day 28 |
| Change in Baseline-adjusted AUC of the TNSS | Baseline, Day 14, Day 28 |
Countries
Canada
Outcome results
None listed