Study of BLU-808 in Allergic Rhinoconjunctivitis | NCT06922448

Studies
Study of BLU-808 in Allergic Rhinoconjunctivitis

NCT06922448

Sponsor

Blueprint Medicines Corporation

Status

Completed

Last Update Posted

Feb 10, 2026Actual

Enrollment

21Actual

Phase

Phase 2

Conditions

Allergic Rhinoconjunctivitis

Interventions

BLU-808
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2025Actual

Primary Completion Date

Sep 8, 2025Actual

Completion Date

Sep 8, 2025Actual

First Submitted Date

Apr 3, 2025

First Submission Date that Met QC Criteria

Apr 3, 2025

First Posted Date

Apr 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BLU-808	Drug	BLU-808 tablets	BLU-808 Dose 1 BLU-808 Dose 2

Measure	Description	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Day 1 through Day 56

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided