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Completed

NCT Number: NCT01066611

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

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vienna Challenge Chamber

Vienna, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAL-263

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Evaluate the safety of CAL-263 in allergic rhinitis subjects

    Time frame: 46 days

Secondary outcomes

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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2010
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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