Study of BLU-808 in Allergic Rhinoconjunctivitis

NCT06922448 | Completed Phase 2 FDA Drug

• 1 other identifier: BLU-808-2201
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergic Rhinoconjunctivitis; Ambrosia Artemisiifolia; BLU-808; Ragweed

Outcome Measures

Primary Outcomes (1)

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

  Day 1 through Day 56

Secondary Outcomes (8)

• 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

Study Arms (3)

BLU-808 Dose 1

EXPERIMENTAL

BLU-808 will be administered orally for 28 days.

Drug: BLU-808

BLU-808 Dose 2

EXPERIMENTAL

BLU-808 will be administered orally for 28 days.

Drug: BLU-808

Placebo

PLACEBO COMPARATOR

Placebo will be administered orally for 28 days.

Drug: Placebo

Interventions

BLU-808 DRUG

BLU-808 tablets

BLU-808 Dose 1; BLU-808 Dose 2

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blueprint Medicines Corporation: lead

Study Sites (1)

Red Maple Trials

Ottawa, ON K1H E4, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: April 14, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-01

Locations

CA (1)