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

May 4, 2011 updated by: Gilead Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Vienna Challenge Chamber

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety of CAL-263 in allergic rhinitis subjects
Time Frame: 46 days
46 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

May 5, 2011

Last Update Submitted That Met QC Criteria

May 4, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 263-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Clinical Trials on CAL-263

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe