54 Participants Needed

BLU-808 for Allergic Rhinoconjunctivitis

BM
Overseen ByBlueprint Medicines
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Blueprint Medicines Corporation
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications for ragweed or other allergy symptoms, as well as any medications that could affect your safety or interfere with the study results.

What data supports the effectiveness of the drug BLU-808 for treating allergic rhinoconjunctivitis?

The research indicates that leukotriene receptor antagonists, like ICI 204,219, can relieve symptoms of allergic rhinitis, which is similar to allergic rhinoconjunctivitis. Additionally, combining leukotriene receptor antagonists with intranasal corticosteroids has been shown to be effective in treating allergic rhinitis, suggesting potential benefits for BLU-808 if it has similar components.12345

What is the purpose of this trial?

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).

Eligibility Criteria

Adults over 18 with a history of ragweed-induced allergic rhinoconjunctivitis (ARC) for more than two years, who have had a positive skin test for ragweed. Participants must show significant nasal and eye symptoms from ARC to join the study.

Inclusion Criteria

Key Inclusion Criteria
3. A positive ragweed skin prick test (mean diameter of ≥ 5 mm) in the last 6 months.
I am 18 or older and agree to participate in the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive BLU-808 or placebo orally for 28 days

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BLU-808
Trial Overview The trial is testing BLU-808's effects on people with ARC caused by ragweed pollen. It will look at how safe it is, how the body processes it, and its early effectiveness compared to a placebo (a substance with no active drug).
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BLU-808 Dose 2Experimental Treatment1 Intervention
BLU-808 will be administered orally for 28 days.
Group II: BLU-808 Dose 1Experimental Treatment1 Intervention
BLU-808 will be administered orally for 28 days.
Group III: PlaceboPlacebo Group1 Intervention
Placebo will be administered orally for 28 days.

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Who Is Running the Clinical Trial?

Blueprint Medicines Corporation

Lead Sponsor

Trials
31
Recruited
6,000+

Findings from Research

Topical nasal corticosteroids are more effective than oral antihistamines for reducing rhinitis symptoms in asthma patients, and they also help relieve symptoms of acute rhinosinusitis faster than antibiotics alone.
Omalizumab, a monoclonal anti-immunoglobulin E antibody, significantly reduces nasal symptoms in patients with ragweed allergic rhinitis, with 70.7% of patients reporting good or excellent treatment outcomes compared to 40.8% in the placebo group.
Therapy in the management of the rhinitis/asthma complex.Greenberger, PA.[2021]

References

The leukotriene D4-receptor antagonist, ICI 204,219, relieves symptoms of acute seasonal allergic rhinitis. [2021]
Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments of Olopatadine Hydrochloride/Mometasone Furoate Monohydrate and Azelastine Hydrochloride/Fluticasone Propionate for Allergic Rhinitis in Australia - An Observational Real-World Clinical Study. [2023]
[Efficacy and safety of monotherapy versus combination therapy in treatment of allergic rhinitis : a Meta-analysis]. [2019]
Therapy in the management of the rhinitis/asthma complex. [2021]
[Leukotriene receptor antagonist as add-on therapy to intranasal corticosteroids in the treatment of allergic rhinitis: a systematic review]. [2018]
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