Study of BLU-808 in Allergic Rhinoconjunctivitis

September 1, 2026 updated by: Blueprint Medicines Corporation

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Ottawa, Canada, ON K1H E4
        • Red Maple Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BLU-808 Dose 1
BLU-808 will be administered orally for 28 days.
Drug: BLU-808
BLU-808 tablets
Experimental: BLU-808 Dose 2
BLU-808 will be administered orally for 28 days.
Drug: BLU-808
BLU-808 tablets
Placebo Comparator: Placebo
Placebo will be administered orally for 28 days.
Drug: Placebo
Placebo tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 56
Day 1 through Day 56

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area Under the Curve (AUC) of BLU-808
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Maximum Plasma Concentration (Cmax) of BLU-808
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Minimum Plasma Concentration (Cmin) of BLU-808
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Apparent Clearance (CL/F) of BLU-808
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Terminal Half-life (t½) of BLU-808
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)
Time Frame: Baseline, Day 14, Day 28
Baseline, Day 14, Day 28
Change in Baseline-adjusted AUC of the TNSS
Time Frame: Baseline, Day 14, Day 28
Baseline, Day 14, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Blueprint Medicines Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLU-808-2201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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