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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066611
• Other study ID #: 263-02
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2010
• Last updated: May 4, 2011
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: May 2011
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• CAL-263
CAL-263 10 mg or placebo once daily for 7 days
• Placebo
CAL-263 10 mg or placebo once daily for 7 days

Locations

Country	Name	City	State
Austria	Vienna Challenge Chamber	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety of CAL-263 in allergic rhinitis subjects		46 days	Yes
Secondary	Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects		7 days	No