Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Status and phase
Completed
Phase 1
Conditions
Allergic Rhinitis
Treatments
Drug: CAL-263
Drug: Placebo
Details and patient eligibility
About
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.
Full description
A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.
Enrollment
48 estimated patients
Sex
All
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Age >18 and <55 years
- Has a history of seasonal allergic rhinitis for at least 2 years
- Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
- Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
- Is otherwise healthy
- Is able to provide written informed consent
Exclusion criteria
- Is a female of childbearing
- History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
- History of nonallergic rhinitis, chronic sinusitis or severe asthma
- Has a nasal condition likely to affect the outcome of the study
- Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
- Has taken a prohibited medication within the specified interval prior to Visit 1
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
48 participants in 2 patient groups, including a placebo group
1
Active Comparator group
Description:
CAL-263
Treatment:
Drug: CAL-263
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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