Evaluating BLU-808 for treating ragweed allergies

A Phase 2a Randomized Double-blinded Placebo Controlled Study to Evaluate the Safety, Tolerability, PK, PD, and Preliminary Clinical Activity of BLU-808, a Wild-type KIT Inhibitor, in Participants With Ragweed (Ambrosia Artemisiifolia)-Induced Allergic Rhinoconjunctivitis

This study is testing a new treatment called BLU-808 to see if it helps adults with ragweed allergies feel better compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Blueprint Medicines Corporation (industry)
• Locations: 1 site (Ottawa)
• Trial ID: NCT06922448 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of BLU-808 in adults suffering from ragweed-induced allergic rhinoconjunctivitis. Participants will be assessed for eligibility through exposure to ragweed pollen in an allergen exposure chamber. The study involves administering either BLU-808 or a placebo to determine the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of ragweed-induced allergic rhinoconjunctivitis and a positive skin prick test for ragweed.

Not a fit: Patients currently receiving allergy medications or those with other significant allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms for patients suffering from ragweed allergies.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating allergic conditions with targeted therapies.

Eligibility 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.

Where this trial is running

Ottawa

• Red Maple Trials — Ottawa, Canada (RECRUITING)

Study contacts

• Study coordinator: Blueprint Medicines

Conditions: Allergic Rhinoconjunctivitis, Ambrosia Artemisiifolia, BLU-808, Ragweed