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

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01066611
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: CAL-263; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 CAL-263	Drug: CAL-263; CAL-263 10 mg or placebo once daily for 7 days
Placebo Comparator: 2 Placebo	Drug: Placebo; CAL-263 10 mg or placebo once daily for 7 days

Outcome Measures

Primary Outcome Measures

1. Evaluate the safety of CAL-263 in allergic rhinitis subjects [46 days]

Secondary Outcome Measures

1. Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Challenge Chamber	Vienna		Austria

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Principal Investigator: Friedrich Horak, MD, Vienna Challenge Chamber

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01066611
• Other Study ID Numbers: 263-02
• First Posted: Feb 10, 2010
• Last Update Posted: May 5, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: Allergic Rhinitis; Allergy; Phosphatidylinositol 3-kinase
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

No Results Posted as of May 5, 2011