Peanut HypersensitivityPhase 2NCT00382148
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
A Phase 2 study testing omalizumab in people with Peanut Hypersensitivity, run by Genentech, Inc..
Trial summary
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study. Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Peanut Hypersensitivity
- What is being tested?
- omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to 28 Jun 2008
- Phase
- Phase 2
- 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 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completion of last visit (or early termination visit, if applicable) for Study Q2788g
- Signed Informed Consent Form
- Use of an effective method of contraception for females of childbearing potential
- Body weight ≥ 20 kg and ≤ 150 kg
- IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)
Who cannot join
- Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
- Current participation in another investigational study
- Pregnancy or lactation
- History of brittle asthma
- Aspirin-sensitive asthma
- Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
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- Have a polymorrphonuclear count <1500/uL
- Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
- Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
- Thrombocytopenia as evidenced by a platelet count < 100,000/uL
- Any systemic condition requiring regular administration of an immunoglobulin
About this study
Official title: A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.
- Conditions
- Peanut Hypersensitivity
- Being tested
- omalizumab
- Keywords
- TOPS, Peanut allergy, Peanut-induced allergy, Allergy
- Medical subject headings
- Peanut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
Subcutaneous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Measured: Through Week 52
Secondary outcomes (3)
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
Measured: Every 4 weeks through Week 52
Food-allergic Reactions As Assessed by the Ewan Scale
The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Grade 1 criteria: localized cutaneous erythema/urticaria/angioedema/oral pruritus. Grade 2 criteria: generalized erythema/urticaria/angioedema. Grade 3 criteria: Grade 1 or 2 events plus GI symptoms/rhinoconjunctivitis. Grade 4 criteria: mild laryngeal edema (voice change, tight throat) and/or mild asthma. Grade 5 criteria: pronounced dyspnea and/or hypotensive symptoms (light headedness/collapse/loss of consciousness). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator.
Measured: Through Week 52
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
Measured: Through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startNov 2006
- Primary completion28 Jun 2008
- Study completion28 Jun 2008
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 Peanut HypersensitivityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Wong, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382148
- Sponsor's protocol ID
- Q3623g
- Status last verified
- May 2026
- First submitted
- 26 Sep 2006
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
- ClinicalTrials.gov ID
- NCT00382148
- Acronym / sponsor ID
- Q3623g
- Conditions
- Peanut Hypersensitivity
- Keywords
- TOPS, Peanut allergy, Peanut-induced allergy, Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- 28 Jun 2008 (actual)
- Study completion
- 28 Jun 2008 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Posted 15 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: omalizumab |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Completion of last visit (or early termination visit, if applicable) for Study Q2788g
- Signed Informed Consent Form
- Use of an effective method of contraception for females of childbearing potential
- Body weight ≥ 20 kg and ≤ 150 kg
- IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)
Key exclusion criteria (11 listed)
- Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
- Current participation in another investigational study
- Pregnancy or lactation
- History of brittle asthma
- Aspirin-sensitive asthma
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 |
|---|---|---|
| omalizumabSubcutaneous repeating dose | Drug | 1 |
Primary outcome
Serious Adverse Events
Time frame: Through Week 52
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
3 secondary outcomes
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Time frame: Every 4 weeks through Week 52
Food-allergic Reactions As Assessed by the Ewan Scale
Time frame: Through Week 52
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Time frame: Through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- 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 2 study testing omalizumab in people with Peanut Hypersensitivity, 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 5 inclusion and 11 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 2 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Dec 2009). 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?
Serious Adverse Events (time frame: Through Week 52). 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 2 Jun 2026.