HealthyPhase 4NCT00777764

The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

A Phase 4 study testing Cohort I and Cohort 2 in people with Healthy and Asthma, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Healthy, Asthma
What is being tested?: Cohort I and Cohort 2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Aug 2008to Apr 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
(Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
Physical examination findings within normal limits
Body mass index (BMI) between 18 and 30, inclusive

Who cannot join

Pregnancy and lactation
Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
History of drug abuse
Participation in an investigational drug or device trial within the last 30 days prior to screening

About this study

Conditions: Healthy, Asthma
Being tested: Cohort I, Cohort 2
Keywords: Xolair, Asthma, Skin Tests
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cohort IDrug
In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
Dilutions of omalizumab and its excipients were in SWFI.
Cohort 2Drug
In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation.
For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
Dilutions of omalizumab and its excipients were made in saline.

Study groups in NCT00777764
Study group	Role	What they receive
Healthy Volunteers	Experimental	Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Receives: Drug: Cohort I
Allergic Asthma Participants	Experimental	Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Receives: Drug: Cohort 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants by of Adverse Events Following a Skin Test Procedure
Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours.
Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death.
Measured: Up to 7 days following skin testing
Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)
For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
Measured: on the day of skin test
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)
For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
Measured: on the day of skin test
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)
For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
Measured: on the day of skin test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Apr 2009

First posted22 Oct 2008 (estimated)
Study startAug 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777764
Sponsor's protocol ID: Q4465g
Status last verified: May 2017
First submitted: 21 Oct 2008
Last updated: 14 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
ClinicalTrials.gov ID: NCT00777764
Acronym / sponsor ID: Q4465g
Conditions: Healthy, Asthma
Keywords: Xolair, Asthma, Skin Tests
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2008 (actual)
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 14 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Healthy Volunteers	Experimental	Drug: Cohort IHealthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients.
Allergic Asthma Participants	Experimental	Drug: Cohort 2Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

(Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
(Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
Physical examination findings within normal limits
Body mass index (BMI) between 18 and 30, inclusive

Key exclusion criteria (6 listed)

Pregnancy and lactation
Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
History of drug abuse

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
Cohort IIn sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were in SWFI.	Drug	Healthy Volunteers
Cohort 2In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were made in saline.	Drug	Allergic Asthma Participants

Primary outcome

Number of Participants by of Adverse Events Following a Skin Test Procedure
Time frame: Up to 7 days following skin testing
Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours. Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death.
Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)
Time frame: on the day of skin test
For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)
Time frame: on the day of skin test
For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)
Time frame: on the day of skin test
For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.

Results and safety

Results posted to the registry on 14 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Subjects	30	30
Allergic Asthma Participants	30	29

Primary outcome: Number of Participants by of Adverse Events Following a Skin Test Procedure

Time frame: Up to 7 days following skin testing. Number. Unit: participants

Measure	Healthy Subjects n = 30	Allergic Asthma Participants n = 30
Any adverse event	1	3
Severity: Mild	0	0
Severity: Moderate	1	3
Severity: Severe	0	0

Population analysed: Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient.

Primary outcome: Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)

Time frame: on the day of skin test. Number. Unit: participants

Measure	Healthy Subjects n = 30	Allergic Asthma Participants n = 30
1:1000 Dilution; Excipient	0	0
1:1000 Dilution; Omalizumab	0	0
1:100 Dilution; Excipient	0	0
1:100 Dilution; Omalizumab	0	0
1:10 Dilution; Excipient	1	0
1:10 Dilution; Omalizumab	0	0
Undiluted; Excipient	2	0
Undiluted; Omalizumab	0	0

Population analysed: Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)

Primary outcome: Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)

Time frame: on the day of skin test. Number. Unit: participants

Measure	Healthy Subjects n = 27
1:1000 Dilution; Excipient	6
1:1000 Dilution; Omalizumab	2
1:100 Dilution; Excipient	7
1:100 Dilution; Omalizumab	6
1:10 Dilution; Excipient	0
1:10 Dilution; Omalizumab	0

Population analysed: Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)

Primary outcome: Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)

Time frame: on the day of skin test. Number. Unit: participants

Measure	Patients With Allergic Asthma n = 30
1:100,000 Dilution; Excipient	1
1:100,000 Dilution; Omalizumab	0
1:10,000 Dilution; Excipient	4
1:10,000 Dilution; Omalizumab	7

Population analysed: Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Subjects	0 of 30 (0%)	1 of 30 (3.3%)	Not reported
Allergic Asthma Participants	0 of 30 (0%)	3 of 30 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Dennis Wong, M.D. study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cohort I and Cohort 2 in people with Healthy and Asthma, run by Genentech, Inc..

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 4 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants by of Adverse Events Following a Skin Test Procedure (time frame: Up to 7 days following skin testing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00777764.

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 14 Jun 2017.