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

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: CAL-263; Drug: Placebo

• Registration Number: NCT01066611
• Lead Sponsor: Gilead Sciences

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	CAL-263	CAL-263
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Evaluate the safety of CAL-263 in allergic rhinitis subjects	46 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vienna Challenge Chamber; 🇦🇹 Vienna, Austria