Allergic RhinitisPhase 1NCT01066611
Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
A Phase 1 study testing CAL-263 in people with Allergic Rhinitis, run by Gilead Sciences at 1 site in Austria.
Trial summary
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- CAL-263
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.
Read the detailed description
A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- CAL-263, Placebo
- Keywords
- Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAL-263Drug
CAL-263 10 mg or placebo once daily for 7 days
PlaceboDrug
CAL-263 10 mg or placebo once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CAL-263 Receives: Drug: CAL-263 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of CAL-263 in allergic rhinitis subjects
Measured: 46 days
Secondary outcomes (1)
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Friedrich Horak, MD, Principal investigator, Vienna Challenge Chamber
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066611
- Sponsor's protocol ID
- 263-02
- Status last verified
- May 2011
- First submitted
- 27 Jan 2010
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01066611
- Acronym / sponsor ID
- 263-02
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CAL-263CAL-263 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAL-263CAL-263 10 mg or placebo once daily for 7 days | Drug | 1 |
| PlaceboCAL-263 10 mg or placebo once daily for 7 days | Drug | 2 |
Primary outcome
Evaluate the safety of CAL-263 in allergic rhinitis subjects
Time frame: 46 days
1 secondary outcome
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedrich Horak, MD principal investigator
Vienna Challenge Chamber
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAL-263 in people with Allergic Rhinitis, run by Gilead Sciences at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of CAL-263 in allergic rhinitis subjects (time frame: 46 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.