Status:
ACTIVE_NOT_RECRUITING
Study of BLU-808 in Allergic Rhinoconjunctivitis
Lead Sponsor:
Blueprint Medicines Corporation
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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)-ind...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Adults, 18 years of age or older, willing to provide written informed consent, and willing to comply with all study requirements.
- History (\>2 years) of ragweed-induced ARC.
- A positive ragweed skin prick test (mean diameter of ≥ 5 mm) in the last 6 months.
- 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:
- 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.
- Have active rhinitis, sinusitis, and/or other severe allergies not associated with the ragweed pollen that may interfere with study symptom assessments.
- 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.
- Clinically significant moderate to severe, uncontrolled cardiovascular, renal or hepatic disease.
- Significant bleeding risk or coagulation disorders.
- Any form of smoking, vaping or history of alcohol and drug abuse.
- 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.
- Inadequately controlled asthma that could affect the safety of the participant or interfere with the assessment or interpretation of study results.
- Known active/latent infection (viral, bacterial, fungal, helminth, or mycobacterial) such as tuberculosis, hepatitis B, hepatitis C, AIDS-related illness, or COVID-19 infection.
- History of sinonasal conditions that may confound the assessment or interpretation of study results.
Exclusion
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06922448
Start Date
April 14 2025
End Date
December 31 2025
Last Update
December 11 2025
Active Locations (1)
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1
Red Maple Trials
Ottawa, Canada, ON K1H E4