Allergic RhinoconjunctivitisPhase 2NCT06922448
Study of BLU-808 in Allergic Rhinoconjunctivitis
A Phase 2 study testing BLU-808 in people with Allergic Rhinoconjunctivitis, run by Blueprint Medicines Corporation at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- BLU-808
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2025to 8 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- BLU-808, Placebo
- Keywords
- Allergic Rhinoconjunctivitis, Ambrosia Artemisiifolia, BLU-808, Ragweed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLU-808Drug
BLU-808 tablets
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| BLU-808 Dose 1 | Experimental | BLU-808 will be administered orally for 28 days. Receives: Drug: BLU-808 |
| BLU-808 Dose 2 | Experimental | BLU-808 will be administered orally for 28 days. Receives: Drug: BLU-808 |
| Placebo | Placebo comparator | Placebo will be administered orally for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 through Day 56
Secondary outcomes (8)
Area Under the Curve (AUC) of BLU-808
Measured: Day 1 to Day 28
Maximum Plasma Concentration (Cmax) of BLU-808
Measured: Day 1 to Day 28
Minimum Plasma Concentration (Cmin) of BLU-808
Measured: Day 1 to Day 28
Apparent Clearance (CL/F) of BLU-808
Measured: Day 1 to Day 28
Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
Measured: Day 1 to Day 28
Terminal Half-life (t½) of BLU-808
Measured: Day 1 to Day 28
Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)
Measured: Baseline, Day 14, Day 28
Change in Baseline-adjusted AUC of the TNSS
Measured: Baseline, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start14 Apr 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blueprint Medicines Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922448
- Sponsor's protocol ID
- BLU-808-2201
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06922448
- Acronym / sponsor ID
- BLU-808-2201
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic Rhinoconjunctivitis, Ambrosia Artemisiifolia, BLU-808, Ragweed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Blueprint Medicines CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLU-808 Dose 1 | Experimental | Drug: BLU-808BLU-808 will be administered orally for 28 days. |
| BLU-808 Dose 2 | Experimental | Drug: BLU-808BLU-808 will be administered orally for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered orally for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLU-808BLU-808 tablets | Drug | BLU-808 Dose 1, BLU-808 Dose 2 |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 56
8 secondary outcomes
Area Under the Curve (AUC) of BLU-808
Time frame: Day 1 to Day 28
Maximum Plasma Concentration (Cmax) of BLU-808
Time frame: Day 1 to Day 28
Minimum Plasma Concentration (Cmin) of BLU-808
Time frame: Day 1 to Day 28
Apparent Clearance (CL/F) of BLU-808
Time frame: 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
Terminal Half-life (t½) of BLU-808
Time frame: Day 1 to Day 28
Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Day 14, Day 28
Change in Baseline-adjusted AUC of the TNSS
Time frame: Baseline, Day 14, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BLU-808 in people with Allergic Rhinoconjunctivitis, run by Blueprint Medicines Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 through Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.