Clinical trial NCT06922448: Study of BLU-808 in Allergic Rhinoconjunctivitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergic Rhinoconjunctivitis
Ambrosia Artemisiifolia
BLU-808
Ragweed
Lead sponsor: Blueprint Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 through Day 56
Secondary outcomes:
measure: Area Under the Curve (AUC) of BLU-808
timeFrame: Day 1 to Day 28
measure: Maximum Plasma Concentration (Cmax) of BLU-808
timeFrame: Day 1 to Day 28
measure: Minimum Plasma Concentration (Cmin) of BLU-808
timeFrame: Day 1 to Day 28
measure: Apparent Clearance (CL/F) of BLU-808
timeFrame: Day 1 to Day 28
measure: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
timeFrame: Day 1 to Day 28
measure: Terminal Half-life (t½) of BLU-808
timeFrame: Day 1 to Day 28
measure: Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)
timeFrame: Baseline, Day 14, Day 28
measure: Change in Baseline-adjusted AUC of the TNSS
timeFrame: Baseline, Day 14, Day 28
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Red Maple Trials
Study officials:
References: