Milk AllergyPhase 2NCT01157117
OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
A Phase 2 study testing Omalizumab and Milk powder in people with Milk Allergy, run by Hugh A Sampson, MD at 3 sites in United States.
Trial summary
Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. Read more about this study
- Who is it for?
- Ages 7 to 35 years
- Conditions the study is for
- Milk Allergy
- What is being tested?
- Omalizumab and Milk powder
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Oct 2015
- 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 7 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject and/or parent/ legal guardian must be able to understand and provide written informed consent
- Written or verbal assent from all study subjects less than 18 years (per site Institutional Review Board (IRB) regulations)
- 7 to 35 years of age; any gender; any racial and ethnic origin
- No known contraindications to therapy using oral immunotherapy with milk protein or Xolair® (omalizumab)
- All female subjects of childbearing potential must have a negative pregnancy test upon study entry
- All treated females of childbearing potential must agree to use FDA approved methods of birth control for the duration of the study
Show all 11Show fewer
- Active Treatment Subjects:
- Cow's milk allergy confirmed by a positive double-blind placebo controlled milk challenge (DBPCMC) to a dose of less than 2 g of milk protein within the past 6 months
- A skin prick test positive to milk (diameter of wheal >= 3.0 mm) OR detectable serum milk specific Immunoglobulin E (IgE) level within the previous 12 months (UniCAP > = 0.35 kUA/L (allergen-equivalent kilounits per liter))
- Control Subjects:
- A skin prick test positive to milk (diameter of wheal >= 10.0 mm) OR detectable serum milk specific IgE level within the previous 12 months (UniCAP >= 15 kUA/L)
Who cannot join
- A history of life-threatening anaphylaxis to milk (involving hypotension or requiring mechanical ventilation)
- Known allergy to any components of the placebo for Xolair®
- Chronic disease other than asthma, atopic dermatitis, or allergic rhinitis requiring therapy (e.g., heart disease, diabetes)
- Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), or calcium channel blockers
- Severe asthma
- Mild or moderate asthma with any of the following criteria met:
Show all 28Show fewer
- Forced expiratory volume in the first second (FEV1) < 80% with or without controller medications
- Inhaled corticosteroids (ICS) dosing of >500 mcg daily fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart)
- history of daily oral steroid dosing for >1 month during the past year
- burst oral steroid course in the past 6 months
- more than one burst oral steroid course in the past year
- more than one hospitalization in the past year for asthma, or
- more than one ER visit in the past 6 months for asthma
- Baseline spirometry (or peak flow rate (PFR) if unable to perform spirometry) result of FEV1<80%
- Pregnancy or lactation. All females of child-bearing age will undergo pregnancy testing. All treated females will confirm compliance to appropriate birth control measures throughout the course of the study;
- Participation in any interventional study for the treatment of food allergy in the past 6 months
- Subject is on a buildup phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose);
- Use of Xolair® (omalizumab) or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual immunotherapy) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
- Inability to discontinue antihistamines for 5 half-lives prior to routine study tests (DBPCMC or endpoint titration tests)
- Known sensitivity to Xolair® (omalizumab) or to the class of study drugs
- Baseline serum total IgE over 1,300 IU/mL or body weight more than 150 kg, or subjects with weight-IgE combination that yields a dose requirement greater than 750 mg (due to limitations of Xolair® (omalizumab) dosing)
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements
- Inability or unwillingness of a subject to give written informed consent or comply with study protocol
- Use of investigational drugs within 90 days of participation
- Other contraindications to milk oral immunotherapy or Xolair® (omalizumab)
- Recipient of any licensed or investigational live attenuated vaccine(s) within 2 months of enrollment
- Families who do not speak English
- Systemic steroids oral, intramuscular (IM), or IV for indications other than asthma for greater than 3 weeks in the past 6 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Oral Immunotherapy Combined With Humanized Monoclonal Anti-IgE Antibody Xolair® (Omalizumab)in the Treatment of Cow's Milk Allergy
Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products.
Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop "tolerance," which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair® (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.
- Conditions
- Milk Allergy
- Being tested
- Placebo for omalizumab, Omalizumab, Milk powder
- Keywords
- food allergy
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo for omalizumabBiological
Also called Placebo for Xolair
Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight).
OmalizumabBiological
Also called Xolair
Omalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight.
Milk powderDrug
Milk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab/milk OIT | Experimental | Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization oral food challenge (OFC). Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28, participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Receives: Biological: Omalizumab; Drug: Milk powder |
| Placebo for omalizumab/milk OIT | Placebo comparator | Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28, participants complete a 10g milk oral food challenge (OFC); if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. Receives: Biological: Placebo for omalizumab; Drug: Milk powder |
| Untreated control | No intervention | Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk
Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.
Measured: Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group
Secondary outcomes (13)
Incidence of Dosing Reactions to Milk OIT During the Escalation Phase
Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.
Measured: Baseline to completion of Escalation Phase at 22 to 40 weeks
Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase
Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.
Measured: After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30
Incidence of Severe Hypersensitivity Reactions to Milk OIT
Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.
Measured: Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)
Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)
Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.
Measured: Baseline to completion of Escalation Phase at 22 to 40 weeks
Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk
Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.
Measured: Month 28
Time to Maximum Tolerated Dose
Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.
Measured: Baseline to completion of Escalation Phase at 22 to 40 weeks
Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test
A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.
Measured: Month 32
Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)
The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.
Measured: Month 32
Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)
Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.
Measured: Month 32
Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)
The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.
Measured: Month 38
Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)
Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.
Measured: Month 38
Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk
Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.
Measured: Month 32
Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk
Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.
Measured: Month 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2015
- Study completionOct 2015
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Milk AllergyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugh A Sampson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Hugh A. Sampson, M.D., Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157117
- Sponsor's protocol ID
- DAIT AADCRC-MSSM-01
- Other IDs
- U19AI044236
- Status last verified
- Aug 2020
- First submitted
- 2 Jul 2010
- Last updated
- 14 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wood RA, Kim JS, Lindblad R, Nadeau K, Henning AK, Dawson P, Plaut M, Sampson HA. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. J Allergy Clin Immunol. 2016 Apr;137(4):1103-1110.e11. doi: 10.1016/j.jaci.2015.10.005. Epub 2015 Nov 12.
PubMed 26581915Noone S, Ross J, Sampson HA, Wang J. Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):424-8. doi: 10.1016/j.jaip.2014.10.008. Epub 2015 Jan 13.
PubMed 25609353
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy Combined With Humanized Monoclonal Anti-IgE Antibody Xolair® (Omalizumab)in the Treatment of Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT01157117
- Acronym / sponsor ID
- DAIT AADCRC-MSSM-01
- Conditions
- Milk Allergy
- Keywords
- food allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hugh A Sampson, MDUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 6 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products.
Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop "tolerance," which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair® (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omalizumab/milk OIT | Experimental | Biological: Omalizumab, Drug: Milk powderParticipants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization oral food challenge (OFC). Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28, participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| Placebo for omalizumab/milk OIT | Placebo comparator | Biological: Placebo for omalizumab, Drug: Milk powderParticipants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28, participants complete a 10g milk oral food challenge (OFC); if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| Untreated control | No intervention | –Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. |
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Subject and/or parent/ legal guardian must be able to understand and provide written informed consent
- Written or verbal assent from all study subjects less than 18 years (per site Institutional Review Board (IRB) regulations)
- 7 to 35 years of age; any gender; any racial and ethnic origin
- No known contraindications to therapy using oral immunotherapy with milk protein or Xolair® (omalizumab)
- All female subjects of childbearing potential must have a negative pregnancy test upon study entry
Key exclusion criteria (28 listed)
- A history of life-threatening anaphylaxis to milk (involving hypotension or requiring mechanical ventilation)
- Known allergy to any components of the placebo for Xolair®
- Chronic disease other than asthma, atopic dermatitis, or allergic rhinitis requiring therapy (e.g., heart disease, diabetes)
- Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), or calcium channel blockers
- Severe 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 |
|---|---|---|
| Placebo for omalizumabAlso: Placebo for XolairPlacebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight). | Biological | Placebo for omalizumab/milk OIT |
| OmalizumabAlso: XolairOmalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight. | Biological | Omalizumab/milk OIT |
| Milk powderMilk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed. | Drug | Omalizumab/milk OIT, Placebo for omalizumab/milk OIT |
Primary outcome
Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk
Time frame: Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group
Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.
13 secondary outcomes
Incidence of Dosing Reactions to Milk OIT During the Escalation Phase
Time frame: Baseline to completion of Escalation Phase at 22 to 40 weeks
Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase
Time frame: After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30
Incidence of Severe Hypersensitivity Reactions to Milk OIT
Time frame: Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)
Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)
Time frame: Baseline to completion of Escalation Phase at 22 to 40 weeks
Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk
Time frame: Month 28
Time to Maximum Tolerated Dose
Time frame: Baseline to completion of Escalation Phase at 22 to 40 weeks
Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test
Time frame: Month 32
Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)
Time frame: Month 32
Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)
Time frame: Month 32
Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)
Time frame: Month 38
Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)
Time frame: Month 38
Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk
Time frame: Month 32
Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk
Time frame: Month 38
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26581915Wood RA, Kim JS, Lindblad R, Nadeau K, Henning AK, Dawson P, Plaut M, Sampson HA. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. J Allergy Clin Immunol. 2016 Apr;137(4):1103-1110.e11. doi: 10.1016/j.jaci.2015.10.005. Epub 2015 Nov 12.
- Derived from this study: PubMed 25609353Noone S, Ross J, Sampson HA, Wang J. Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):424-8. doi: 10.1016/j.jaip.2014.10.008. Epub 2015 Jan 13.
Related trials for Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
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.
Hugh A. Sampson, M.D. study chair
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab and Milk powder in people with Milk Allergy, run by Hugh A Sampson, MD at 3 sites in United States.
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 11 inclusion and 28 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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 6 Apr 2016). 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?
Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk (time frame: Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group). 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 NCT01157117, which also lists 2 linked publications.
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 Aug 2020.