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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

CAL-263

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Vienna Challenge Chamber

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

CAL-263

Placebo

Outcomes

Primary Outcome Measures

Evaluate the safety of CAL-263 in allergic rhinitis subjects

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01066611

First Posted

January 27, 2010

Last Updated

May 4, 2011

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01066611

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

CAL-263

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

CAL-263

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluate the safety of CAL-263 in allergic rhinitis subjects

Time Frame

46 days

Secondary Outcome Measure Information:

Title

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

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Friedrich Horak, MD

Organizational Affiliation

Vienna Challenge Chamber

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vienna Challenge Chamber

City

Vienna

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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