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Completed

NCT Number: NCT06922448

Study of BLU-808 in Allergic Rhinoconjunctivitis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Red Maple Trials

Ottawa, ON K1H E4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BLU-808

Drug

BLU-808 tablets

Placebo

Drug

Placebo tablets

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 through Day 56

Secondary outcomes

  1. Area Under the Curve (AUC) of BLU-808

    Time frame: Day 1 to Day 28

  2. Maximum Plasma Concentration (Cmax) of BLU-808

    Time frame: Day 1 to Day 28

  3. Minimum Plasma Concentration (Cmin) of BLU-808

    Time frame: Day 1 to Day 28

  4. Apparent Clearance (CL/F) of BLU-808

    Time frame: Day 1 to Day 28

  5. Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808

    Time frame: Day 1 to Day 28

  6. Terminal Half-life (t½) of BLU-808

    Time frame: Day 1 to Day 28

  7. Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)

    Time frame: Baseline, Day 14, Day 28

  8. Change in Baseline-adjusted AUC of the TNSS

    Time frame: Baseline, Day 14, Day 28

Sponsors and collaborators

Lead sponsor

Blueprint Medicines Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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