Study of BLU-808 in Allergic Rhinoconjunctivitis

Phase 2

Recruiting

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Placebo; Drug: BLU-808

• Registration Number: NCT06922448
• Lead Sponsor: Blueprint Medicines Corporation

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-10
• Study Start: 2025-04-14
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be administered orally for 28 days.
BLU-808 Dose 1	BLU-808	BLU-808 will be administered orally for 28 days.
BLU-808 Dose 2	BLU-808	BLU-808 will be administered orally for 28 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Day 1 through Day 56

Secondary Outcome Measures

Name	Time	Method
Minimum Plasma Concentration (Cmin) of BLU-808	Day 1 to Day 28
Change in Baseline-adjusted AUC of the TNSS	Baseline, Day 14, Day 28
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
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
Terminal Half-life (t½) of BLU-808	Day 1 to Day 28
Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)	Baseline, Day 14, Day 28

Trial Locations

Locations (1)

Red Maple Trials; 🇨🇦 Ottawa, Canada