Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066611

Enrollment

Registered

2010-02-10

Start date

2010-01-31

Completion date

2010-04-30

Last updated

2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase

Brief summary

The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.

Detailed description

A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.

Interventions

DRUGCAL-263

CAL-263 10 mg or placebo once daily for 7 days

DRUGPlacebo

CAL-263 10 mg or placebo once daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

1. Age \>18 and \<55 years 2. Has a history of seasonal allergic rhinitis for at least 2 years 3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing 4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening 5. Is otherwise healthy 6. Is able to provide written informed consent

Exclusion criteria

1. Is a female of childbearing 2. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis 3. History of nonallergic rhinitis, chronic sinusitis or severe asthma 4. Has a nasal condition likely to affect the outcome of the study 5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies 6. Has taken a prohibited medication within the specified interval prior to Visit 1

Design outcomes

Primary

Measure	Time frame
Evaluate the safety of CAL-263 in allergic rhinitis subjects	46 days

Secondary

Measure	Time frame
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects	7 days

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026