Allergy, PeanutPhase 3VITESSENCT05741476

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

A Phase 3 study testing DBV712 in people with Allergy, Peanut, run by DBV Technologies at 87 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period. Read more about this study

Who is it for?: Ages 4 to 7 years
Conditions the study is for: Allergy, Peanut
What is being tested?: DBV712
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 600 participants
Where: 87 sitesin 9 countries
Study dates: 21 Feb 2023to Oct 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 4 to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

Aged 4 through 7 years at Visit 1 (screening).
Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
An ED of ≤100 mg peanut protein at screening DBPCFC.
Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria:
Signed ICF by the participant's parent(s)/caregiver(s). This consent should be signed after completion of the procedures in the randomized, DBPC Treatment Period, and before any procedure in Open-label Extension Period begins.
Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80% compliance with investigational medicinal product (IMP).
Parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study.

Who cannot join

Severe generalized dermatologic disease involving the application area (interscapular region)
Uncontrolled persistent asthma.
Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria:
Participants who develop a severe anaphylactic reaction during the DBPCFC at the end of Month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma. Participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the Open-label Extension Period, at the judgement of the Investigator.
Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.

Trial locations and contacts

87 sites in 9 countries.

Country

City, postcode or hospital

87 sites in 9 countries

United States50 sites

DBV Investigative Site
Ann Arbor, Michigan, 48106
DBV Investigative site
Atlanta, Georgia, 30329
DBV Investigative Site
Aurora, Colorado, 80045
DBV Investigative Site
Austin, Texas, 78723
DBV Investigative Site
Baltimore, Maryland, 21287
DBV Investigative Site
Birmingham, Alabama, 35233
DBV Investigative Site
Boston, Massachusetts, 02114
DBV Investigative Site
Boston, Massachusetts, 02115
DBV Investigative Site
Chapel Hill, North Carolina, 27599
DBV Investigative Site
Chevy Chase, Maryland, 20815
DBV Investigative Site
Chicago, Illinois, 60611
DBV Investigative Site
Cincinnati, Ohio, 45229
DBV Investigative Site
Cleveland, Ohio, 44106
DBV Investigative Site
Cleveland, Ohio, 44195
DBV Investigative Site
Colorado Springs, Colorado, 80907
DBV Investigative Site
Columbus, Ohio, 43205
DBV Investigative Site
Dallas, Texas, 75235
DBV Investigative Site
Great Neck, New York, 11021
DBV Investigative Site
Hollywood, Florida, 33021
DBV Investigative Site
Houston, Texas, 77030
DBV Investigative Site
Indianapolis, Indiana, 46202
DBV Investigative Site
Kansas City, Missouri, 64108
DBV Investigative Site
Little Rock, Arkansas, 72202
DBV Investigative Site
Los Angeles, California, 90027
DBV Investigative Site
Los Angeles, California, 90095
DBV Investigative Site
Louisville, Kentucky, 40215
DBV Investigative Site
Maplewood, Minnesota, 55109
DBV Investigative Site
Marietta, Georgia, 30060
DBV Investigative Site
Memphis, Tennessee, 38105
DBV Investigative Site
Miami, Florida, 33136
DBV Investigative Site
Milwaukee, Wisconsin, 53226
DBV Investigative site
Mission Viejo, California, 92691
DBV Investigative Site
Nashville, Tennessee, 37232
DBV Investigative Site
New York, New York, 10016
DBV Investigative Site
New York, New York, 10029
DBV Investigative Site
Normal, Illinois, 61761
DBV Investigative Site
Philadelphia, Pennsylvania, 19104
DBV Investigative Site
Pittsburgh, Pennsylvania, 15224
DBV Investigative Site
Rochester, New York, 14642
DBV Investigative Site
San Diego, California, 92123
DBV Investigative Site
San Francisco, California, 94158
DBV Investigative Site
San Jose, California, 95117
DBV Investigative Site
Seattle, Washington, 98101
DBV Investigative Site
Seattle, Washington, 98115
DBV Investigative Site
St. Petersburg, Florida, 33701
DBV Investigative Site
Tampa, Florida, 33613
DBV Investigative Site
Taunton, Massachusetts, 02780
DBV Investigative Site
Tucson, Arizona, 85724
DBV Investigative Site
Washington D.C., District of Columbia, 20010
DBV Investigative Site
Ypsilanti, Michigan, 48197

Other trials in United States

Canada10 sites

DBV Investigative Site
Burlington, Ontario, L7L6W6
DBV Investigative Site
Hamilton, L8SIG5
DBV Investigative Site
Montreal, Quebec, H3T 1C5
DBV Investigative Site
Montreal, Quebec, H4A3J1
DBV Investigative Site
North York, Ontario, M3B3S6
DBV Investigative Site
Ottawa, Ontario, M5G 1X8
DBV Investigative Site
Québec, Quebec, G1v4W2
DBV Investigative Site
Toronto, Ontario, K1H1E4
DBV Investigative Site
Vancouver, British Columbia, V6H 3V4
DBV Investigative Site
Winnipeg, Manitoba, R3J 0S9

Other trials in Canada

Australia6 sites

DBV Investigative Site
Adelaide, 5006
DBV Investigative Site
Nedlands, 6009
DBV Investigative Site
Parkville, 3052
DBV Investigative Site
Richmond, 3121
DBV Investigative Site
South Brisbane, 4101
DBV Investigative Site
Westmead, 2145

Other trials in Australia

France6 sites

DBV Investigative Site
Angers, 49933
DBV Investigative Site
Brest, 29609
DBV Investigative Site
Bron, 69500
DBV Investigative Site
Nice, 06200
DBV Investigative Site
Strasbourg, 67091
DBV Investigative Site
Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom5 sites

DBV Investigative Site
London, SE1 7ETH
DBV Investigative Site
London, W2 1NY
DBV Investigative Site
Manchester, M13 9WL
DBV Investigative Site
Sheffield, S10 2TH
DBV Investigative Site
Southampton, SO16 6YD

Other trials in United Kingdom

Germany3 sites

DBV Investigative Site
Düsseldorf, 40217
DBV Investigative Site
Frankfurt, 60590
DBV Investigative Site
Ulm, 89075

Other trials in Germany

Spain3 sites

DBV Investigative Site
Madrid, 28009
DBV Investigative Site
Madrid, 28034
DBV Investigative Site
Málaga, CP 29011

Other trials in Spain

Ireland2 sites

DBV Investigative Site
Cork, T12 DC4A
DBV Investigative Site
Dublin, D12N512

Other trials in Ireland

Netherlands2 sites

DBV Investigative Site
Rotterdam, 3015 CN
DBV Investigative Site
Utrecht, 3584 EA

Other trials in Netherlands

About this study

Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

Read the detailed description

This study is consisting of a 4-week Screening Period, 12-month DBPC Treatment Period and an open-label extension of either 24 or 36-months duration so that each participant may have the opportunity to receive DBV712 for a total duration of 36 months. Following 36 months of treatment with DBV712 250 mcg, sustained unresponsiveness (SU) will be evaluated by subsequent open food challenge(s) [FC(s)] at 2-, 4-, and 6-months off treatment.

Maximum participant participation will be either approximately 44 or 56 months, depending on the participant's randomized treatment assignment. During the 4-week Screening Period, participants are required to meet 2 sequential screening parameters to determine eligibility prior to randomization:

Assessment of peanut skin prick test (SPT) and serum peanut immunoglobulin-E (IgE)
Peanut double-blind placebo-controlled food challenge (DBPCFC) to confirm peanut allergy and establish an entry peanut eliciting dose (ED). Participants with a peanut protein ED less than or equal to (≤) 100 milligram (mg) will be eligible for randomization.

The starting dose of the eligibility peanut DBPCFC will be 1 mg peanut protein and will escalate up to a highest single dose of 100 mg peanut protein (cumulative 144 mg) via the following schedule: 1, 3, 10, 30, 100 mg. Participants who react, with an eliciting dose (ED) (with dose-limiting symptoms) at or below the dose of 100 mg peanut protein will be considered eligible.

Randomization of eligible participants will occur in a 2:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Conditions: Allergy, Peanut
Being tested: DBV712, Placebo
Keywords: Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy
Medical subject headings: Peanut Hypersensitivity, Nut and Peanut Hypersensitivity, Food Hypersensitivity

What participants receive

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

DBV712Drug
Also called ViaskinTM Peanut
DBV712 250 mcg epicutaneous system.
PlaceboOther
DBV712 matching placebo epicutaneous system.
DBV712Drug
Also called ViaskinTM Peanut
DBV712 250 mcg epicutaneous system.

Study groups in NCT05741476
Study group	Role	What they receive
DBPC Treatment Period: DBV712 250 mcg	Experimental	Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose). Receives: Drug: DBV712
DBPC Treatment Period: Placebo	Placebo comparator	Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose). Receives: Other: Placebo
Open Label Extension Period: DBV712 250 mcg	Experimental	Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36). Receives: Drug: DBV712

What is being measured

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

DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was > 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.
Measured: At Month 12

Secondary outcomes (4)

DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein
The Peanut Protein CRD is defined as the sum of all peanut protein doses taken by the participant during the DBPCFC (including the ED and any partial dose given before the reaction).
Measured: At Month 12
DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein
Measured: At Month 12
DBPC Treatment Period: Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
Measured: At Month 12
DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
The maximum severity of allergic reaction will be assessed according to Consortium of Food Allergy Research (CoFAR) Grading Scale Version 3.0. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction.
Measured: Baseline up to Month 12

Timeline

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

21 Feb 2023Oct 2029

First posted23 Feb 2023
Study start21 Feb 2023
Primary completion6 Nov 2025
Study completionOct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Allergy, PeanutStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05741476
Sponsor's protocol ID: V712-306 (VITESSE)
Other IDs: EU CTIS
Acronym: VITESSE
Status last verified: Jan 2026
First submitted: 14 Feb 2023
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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?

See locations

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A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
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All Allergy, Peanut trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)
ClinicalTrials.gov ID: NCT05741476
Acronym / sponsor ID: VITESSE / V712-306 (VITESSE)
Conditions: Allergy, Peanut
Keywords: Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: DBV TechnologiesIndustry (pharma, biotech, devices)
Study start: 21 Feb 2023 (actual)
Primary completion: 6 Nov 2025 (actual)
Study completion: Oct 2029 (estimated)
First posted: 23 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Assessment of peanut skin prick test (SPT) and serum peanut immunoglobulin-E (IgE)
Peanut double-blind placebo-controlled food challenge (DBPCFC) to confirm peanut allergy and establish an entry peanut eliciting dose (ED). Participants with a peanut protein ED less than or equal to (≤) 100 milligram (mg) will be eligible for randomization.

Randomization of eligible participants will occur in a 2:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
DBPC Treatment Period: DBV712 250 mcg	Experimental	Drug: DBV712Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
DBPC Treatment Period: Placebo	Placebo comparator	Other: PlaceboParticipants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
Open Label Extension Period: DBV712 250 mcg	Experimental	Drug: DBV712Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36).

Who may qualify

Ages: 4 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Aged 4 through 7 years at Visit 1 (screening).
Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
An ED of ≤100 mg peanut protein at screening DBPCFC.
Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria:

Key exclusion criteria (7 listed)

Severe generalized dermatologic disease involving the application area (interscapular region)
Uncontrolled persistent asthma.
Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria:

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
DBV712Also: ViaskinTM PeanutDBV712 250 mcg epicutaneous system.	Drug	DBPC Treatment Period: DBV712 250 mcg
PlaceboDBV712 matching placebo epicutaneous system.	Other	DBPC Treatment Period: Placebo
DBV712Also: ViaskinTM PeanutDBV712 250 mcg epicutaneous system.	Drug	Open Label Extension Period: DBV712 250 mcg

Primary outcome

DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group
Time frame: At Month 12
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was > 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.

4 secondary outcomes

DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein
Time frame: At Month 12
DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein
Time frame: At Month 12
DBPC Treatment Period: Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
Time frame: At Month 12
DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
Time frame: Baseline up to Month 12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.

Related trials for Allergy, Peanut

Active, not recruitingPhase 2
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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.

87 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DBV712 in people with Allergy, Peanut, run by DBV Technologies at 87 sites in 9 countries.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Canada, Australia, France, United Kingdom and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group (time frame: At Month 12). 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 NCT05741476.

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 22 Jan 2026.