Allergy, PeanutPhase 2NCT05432388
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
A Phase 2 study testing LOU064 in people with Allergy, Peanut, run by Novartis Pharmaceuticals at 24 sites in United States.
Trial summary
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergy, Peanut
- What is being tested?
- LOU064
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 24 sitesUnited States
- Study dates
- 12 Oct 2022to 11 Mar 2025
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medical History of allergy to peanuts
- Positive peanut IgE >= 0.35 kUA/L
- Positive Skin Prick test for peanut allergen during screening for study
- Positive Oral Food Challenge to peanut during screening for study
- Willingness to comply with study schedule and procedures and avoid other allergens during study period
Who cannot join
- History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening
- Uncontrolled asthma
- Bleeding risk or coagulation disorder(s)
- Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted)
- History of splenectomy
- Any significant disease that would put the safety of the patient at risk. This includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of GI bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, 48109
Johns Hopkins Hospital
Baltimore, Maryland, 21287
CenExel HRI
Berlin, New Jersey, 08009
Allervie Clinical Research
Birmingham, Alabama, 35209
Treasure Valley Medical Research
Boise, Idaho, 83706
Massachusetts General Hospital
Boston, Massachusetts, 02114
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, 20815
Asthma and Allergy Associates P C
Colorado Springs, Colorado, 80907
CR Services Acquisition US Main center
Columbus, Ohio, 43213
CR Services Acquisition US
Columbus, Ohio, 43213
Colorado Allergy and Asthma Ctr PC
Denver, Colorado, 80230
Western Sky Medical Research
El Paso, Texas, 79924
Bluegrass Allergy Research .
Lexington, Kentucky, 40509
Bluegrass Allergy Research
Lexington, Kentucky, 40509
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Family Allergy and Asthma
Louisville, Kentucky, 40217
Midwest Allergy Sinus Asthma SC
Normal, Illinois, 61761
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, 60305
Allergy Associates of Utah
Sandy City, Utah, 84093
Seattle Allergy and Asthma Rsch
Seattle, Washington, 98115
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, 74136
Allergy and Asthma Clin Res Inc
Walnut Creek, California, 94598
Childrens National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
Read the detailed description
This was a randomized, participant- and investigator-blinded, placebo-controlled study to assess the safety and clinical efficacy of oral LOU064 versus placebo across five treatment arms in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy for one-month treatment period (up to 5 weeks). Participants had oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.
- Conditions
- Allergy, Peanut
- Being tested
- LOU064, placebo
- Keywords
- Groundnut Hypersensitivity, Hypersensitivity, Peanut, Peanut Allergy, Food Allergy, Oral food challenge, IgE, Remibrutinib, BTKi
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOU064Drug
Also called remibrutinib
oral tablets
placeboDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| LOU064 10 mg | Experimental | LOU064 10 mg was administered orally twice per day, on Days 1 through 28. Receives: Drug: LOU064 |
| LOU064 25 mg | Experimental | LOU064 25 mg was administered orally twice per day, on Days 1 through 28. Receives: Drug: LOU064 |
| LOU064 100 mg | Experimental | LOU064 100 mg was administered orally twice per day, on Days 1 through 28. Receives: Drug: LOU064 |
| Placebo + LOU064 25 mg | Experimental | Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28. Receives: Drug: LOU064; Drug: placebo |
| Placebo | Placebo comparator | Placebo was administered orally twice per day, on Days 1 through 28. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Measured: Week 4
Secondary outcomes (12)
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Measured: Week 4
Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Measured: Week 4
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Measured: Week 4
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 3000 mg during the DBPCFC conducted at one month, will be categorized as 4 levels: None, Mild, Moderate, Severe.
Measured: 4 weeks
Change From Baseline of Peanut-specific IgE (Including Peanut Components)
IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Measured: Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)
IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Measured: Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters
An allergen specific skin prick test (SPT) is a commonly used diagnostic tool. In this study a titration SPT using peanut allergen provided additional information on the impact of Bruton's tyrosine kinase (BTK) suppression on skin mast cells. Skin reactions were recorded after 15 minutes of applying allergen to the pricked location. The size of the wheel and flare (the longest diameter and the midpoint orthogonal diameter) at each site were recorded.
Measured: Baseline, Day 26
Maximum Observed Blood Concentration (Cmax) of LOU064
Cmax is the maximum (peak) observed blood concentration of LOU064 after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Measured: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Blood Concentration-time Curve (AUClast) of LOU064
AUClast is the area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LOU064. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Measured: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064
AUCtau is the area under the plasma concentration-time curve. Estimation of AUCtau values required extrapolation of the concentration-time profile from the last measured time-point at 4 h to the end of dosing interval at 12 h post-dose. In some cases, this extrapolation was not possible. For this reason, the number of participants with measurable AUCtau values was less when compared to those with AUClast. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Measured: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064
Tmax is the time to reach maximum (peak) of LOU064 blood concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Measured: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start12 Oct 2022
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
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 Allergy, PeanutStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432388
- Sponsor's protocol ID
- CLOU064I12201
- Other IDs
- 2021-006950-30
- Status last verified
- May 2026
- First submitted
- 31 May 2022
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
- ClinicalTrials.gov ID
- NCT05432388
- Acronym / sponsor ID
- CLOU064I12201
- Conditions
- Allergy, Peanut
- Keywords
- Groundnut Hypersensitivity, Hypersensitivity, Peanut, Peanut Allergy, Food Allergy, Oral food challenge, IgE, Remibrutinib, BTKi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
Detailed description
This was a randomized, participant- and investigator-blinded, placebo-controlled study to assess the safety and clinical efficacy of oral LOU064 versus placebo across five treatment arms in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy for one-month treatment period (up to 5 weeks). Participants had oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LOU064 10 mg | Experimental | Drug: LOU064LOU064 10 mg was administered orally twice per day, on Days 1 through 28. |
| LOU064 25 mg | Experimental | Drug: LOU064LOU064 25 mg was administered orally twice per day, on Days 1 through 28. |
| LOU064 100 mg | Experimental | Drug: LOU064LOU064 100 mg was administered orally twice per day, on Days 1 through 28. |
| Placebo + LOU064 25 mg | Experimental | Drug: LOU064, Drug: placeboPlacebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28. |
| Placebo | Placebo comparator | Drug: placeboPlacebo was administered orally twice per day, on Days 1 through 28. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medical History of allergy to peanuts
- Positive peanut IgE >= 0.35 kUA/L
- Positive Skin Prick test for peanut allergen during screening for study
- Positive Oral Food Challenge to peanut during screening for study
- Willingness to comply with study schedule and procedures and avoid other allergens during study period
Key exclusion criteria (7 listed)
- History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening
- Uncontrolled asthma
- Bleeding risk or coagulation disorder(s)
- Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted)
- History of splenectomy
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 |
|---|---|---|
| LOU064Also: remibrutiniboral tablets | Drug | LOU064 10 mg, LOU064 100 mg, LOU064 25 mg, Placebo + LOU064 25 mg |
| placebooral tablets | Drug | Placebo, Placebo + LOU064 25 mg |
Primary outcome
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Time frame: Week 4
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
12 secondary outcomes
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Time frame: Week 4
Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Time frame: Week 4
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo
Time frame: Week 4
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC
Time frame: 4 weeks
Change From Baseline of Peanut-specific IgE (Including Peanut Components)
Time frame: Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)
Time frame: Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters
Time frame: Baseline, Day 26
Maximum Observed Blood Concentration (Cmax) of LOU064
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Blood Concentration-time Curve (AUClast) of LOU064
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 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 LOU064 in people with Allergy, Peanut, run by Novartis Pharmaceuticals at 24 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 5 inclusion and 7 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 12 Jun 2026). 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 Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms (time frame: Week 4). 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 12 Jun 2026.