Peanut AllergyPhase 3PEPITESNCT02636699
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
A Phase 3 study testing Viaskin Peanut 250mcg in people with Peanut Allergy, run by DBV Technologies at 31 sites in 5 countries.
Trial summary
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT). Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Viaskin Peanut 250mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Dec 2015to 18 Aug 2017
- Phase
- Phase 3
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- Male or female children aged 4 through 11 years;
- Physician-diagnosis of peanut allergy or children with a well documented medical history of IgE-mediated symptoms after ingestion of peanut and currently following a strict peanut-free diet, but without a physician diagnosis;
- Peanut-specific IgE level (ImmunoCAP system) >0.7 kU/L;
- Positive peanut skin prick test (SPT) with a largest wheal diameter:
- ≥6 mm for children 4 through 5 years of age at Visit 1,
- ≥8 mm for children 6 years and above at Visit 1;
- Positive DBPCFC at ≤300 mg peanut protein.
Main Exclusion Criteria:
- History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence);
- Generalized dermatologic disease
- Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as well as hereditary or idiopathic angioedema;
- Diagnosis of asthma that fulfills any of the following criteria:
- Uncontrolled persistent asthma as defined by National Asthma Education and Prevention Program Asthma guidelines 2007 or by Global Initiative for Asthma guidelines 2015,
- Asthma treated with either a high daily high dose of inhaled corticosteroid or with a combination therapy of a medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist or with a combination therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist. Asthmatic subjects treated with a medium daily dose of inhaled corticosteroids are eligible. Intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are also eligible,
- Two or more systemic corticosteroid courses for asthma in the past year or 1 oral corticosteroid course for asthma within 3 months prior to Visit 1, or during screening period,
- Prior intubation/mechanical ventilation for asthma within 1 year prior to Visit 1, or during screening;
- Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy;
- Received anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within 1 year prior to Visit 1, during screening period or during study participation;
- Use of systemic long-acting corticosteroids within 12 weeks prior to Visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks prior to Visit 1 or during screening;
- Prior or concomitant history of any immunotherapy to any food;
- Receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. Aeroallergen immunotherapy must be discontinued at the time of Visit 1;
- Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
United States17 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Childrens' Hospital
Boston, Massachusetts, 02115
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Medical Center of Dallas
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Jaffe Food Allergy Institute
New York, New York, 10029
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, Rady Children's Hospital
San Diego, California, 92123
ASTHMA, Inc.
Seattle, Washington, 98115
Stanford University School of Medicine
Stanford, California, 94305
Canada6 sites
Cheema Research Inc.
Mississauga, Ontario, L5A 3V4
CHUM & CHU Sainte-Justine
Montreal, Quebec, H3T 1C4
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, K1Y 4G2
Centre de Recherche Appliquée en Allergie de Québec (CRAAQ)
Québec, QC G1V4M6
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V 1R2
British Columbia Children's Hospital
Vancouver, British Columbia, V5H 3V4
Australia3 sites
Allergy Medical
Brisbane
Princess Margaret Hospital for Children
Perth
Children's Hospital Westmead
Sydney
Germany3 sites
Charité Universitätsmedizin Berlin
Berlin, D-13353
St.-Marien-Hospital
Bonn, D-53115
Universitätsklinikum Erlangen
Erlangen
Ireland2 sites
Clinical Investigations Unit
Cork
Our Lady's Children's Hospital
Dublin
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).
Read the detailed description
This is a 12-month, Phase III, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of Viaskin Peanut, dosed at 250µg peanut protein (per patch) in peanut-allergic children from 4 through 11 years of age.
The overall maximum study duration for each subject is approximately 61 weeks (6-week screening period, 12-month treatment period and 2-week follow-up period).
During the screening period, subjects will undergo a first screening visit and an entry double-blind, placebo-controlled food challenge (DBPCFC) to peanut to confirm their allergy and their entry peanut eliciting dose (ED). The starting dose of the challenge will be 1 mg peanut protein and will escalate up to a highest dose of 300mg peanut protein. Subjects who react at or below the dose of 300mg peanut protein are considered eligible.
Randomization of eligible subjects will occur in a 2:1 ratio to Viaskin Peanut dosed at 250µg peanut protein (active treatment) or placebo. Subjects will be stratified at randomization by their entry/screening DBPCFC ED in 1 of the following 2 strata and by study center:
- Stratum 1: children with a screening ED of 1mg, 3mg or 10mg;
- Stratum 2: children with a screening ED of 30mg, 100mg or 300mg.
Subjects will apply a Viaskin patch containing either peanut protein or placebo daily for a period of 12 months. At Month 12, a post-treatment DBPCFC to peanut will be performed, with a starting dose of 1 mg peanut protein with escalation up to a highest dose of 2,000 mg peanut protein. This evaluation will help determine the primary efficacy endpoint of this pivotal study.
- Conditions
- Peanut Allergy
- Being tested
- Viaskin Peanut 250mcg, Placebo
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin Peanut 250mcgBiological
Also called DBV712
Peanut extract cutaneous patch
PlaceboBiological
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract
| Study group | Role | What they receive |
|---|---|---|
| Viaskin Peanut 250mcg | Experimental | One Viaskin epicutaneous delivery system (patch) containing 250 µg of peanut protein applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. Receives: Biological: Viaskin Peanut 250mcg |
| Placebo | Placebo comparator | One Viaskin epicutaneous delivery system (patch) containing placebo applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population
The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if:
- ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or
- ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2).
Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.
Measured: At Month 12
Secondary outcomes (2)
Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup
The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if:
- ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or
- ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2).
Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented below. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed for each separate screening ED subgroup.
Measured: At Month 12
Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12
The CRD was calculated as the sum of all doses given (including any repeated and partial doses). The median CRD of peanut protein at baseline and Month 12 is presented. Analysis was performed using the modified baseline observation carried forward method to impute missing data at Month 12.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
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 (4)Papers the sponsor has linked to this study.
- Other trials for Peanut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- DBV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M Fleischer, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636699
- Sponsor's protocol ID
- PEPITES
- Acronym
- PEPITES
- Status last verified
- Jun 2025
- First submitted
- 19 Nov 2015
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fleischer DM, Greenhawt M, Sussman G, Begin P, Nowak-Wegrzyn A, Petroni D, Beyer K, Brown-Whitehorn T, Hebert J, Hourihane JO, Campbell DE, Leonard S, Chinthrajah RS, Pongracic JA, Jones SM, Lange L, Chong H, Green TD, Wood R, Cheema A, Prescott SL, Smith P, Yang W, Chan ES, Byrne A, Assa'ad A, Bird JA, Kim EH, Schneider L, Davis CM, Lanser BJ, Lambert R, Shreffler W. Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial. JAMA. 2019 Mar 12;321(10):946-955. doi: 10.1001/jama.2019.1113.
PubMed 30794314Greenhawt M, Kim EH, Campbell DE, Green TD, Lambert R, Fleischer DM. Improvements in eliciting dose across baseline sensitivities following 12 months of epicutaneous immunotherapy (EPIT) in peanut-allergic children aged 4 to 11 years. J Allergy Clin Immunol Pract. 2020 Oct;8(9):3219-3221. doi: 10.1016/j.jaip.2020.05.030. Epub 2020 Jun 2. No abstract available.
PubMed 32502548Remington BC, Campbell DE, Green TD, Fleischer DM, Koppelman SJ. Post hoc analysis of epicutaneous immunotherapy for peanut allergy phase 3 results: Relevance for exposure through restaurant meals. Ann Allergy Asthma Immunol. 2021 Feb;126(2):208-209. doi: 10.1016/j.anai.2020.11.015. Epub 2020 Nov 28. No abstract available.
PubMed 33259921Remington BC, Krone T, Kim EH, Bird JA, Green TD, Lack G, Fleischer DM, Koppelman SJ. Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy. Ann Allergy Asthma Immunol. 2019 Nov;123(5):488-493.e2. doi: 10.1016/j.anai.2019.08.007. Epub 2019 Aug 20.
PubMed 31442495
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children
- ClinicalTrials.gov ID
- NCT02636699
- Acronym / sponsor ID
- PEPITES / PEPITES
- Conditions
- Peanut Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 15 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).
Detailed description
This is a 12-month, Phase III, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of Viaskin Peanut, dosed at 250µg peanut protein (per patch) in peanut-allergic children from 4 through 11 years of age.
The overall maximum study duration for each subject is approximately 61 weeks (6-week screening period, 12-month treatment period and 2-week follow-up period).
During the screening period, subjects will undergo a first screening visit and an entry double-blind, placebo-controlled food challenge (DBPCFC) to peanut to confirm their allergy and their entry peanut eliciting dose (ED). The starting dose of the challenge will be 1 mg peanut protein and will escalate up to a highest dose of 300mg peanut protein. Subjects who react at or below the dose of 300mg peanut protein are considered eligible.
Randomization of eligible subjects will occur in a 2:1 ratio to Viaskin Peanut dosed at 250µg peanut protein (active treatment) or placebo. Subjects will be stratified at randomization by their entry/screening DBPCFC ED in 1 of the following 2 strata and by study center:
- Stratum 1: children with a screening ED of 1mg, 3mg or 10mg;
- Stratum 2: children with a screening ED of 30mg, 100mg or 300mg.
Subjects will apply a Viaskin patch containing either peanut protein or placebo daily for a period of 12 months. At Month 12, a post-treatment DBPCFC to peanut will be performed, with a starting dose of 1 mg peanut protein with escalation up to a highest dose of 2,000 mg peanut protein. This evaluation will help determine the primary efficacy endpoint of this pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viaskin Peanut 250mcg | Experimental | Biological: Viaskin Peanut 250mcgOne Viaskin epicutaneous delivery system (patch) containing 250 µg of peanut protein applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. |
| Placebo | Placebo comparator | Biological: PlaceboOne Viaskin epicutaneous delivery system (patch) containing placebo applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Viaskin Peanut 250mcgAlso: DBV712Peanut extract cutaneous patch | Biological | Viaskin Peanut 250mcg |
| PlaceboCutaneous patch containing an inactive deposit manufactured to mimic peanut extract | Biological | Placebo |
Primary outcome
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population
Time frame: At Month 12
The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.
2 secondary outcomes
Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup
Time frame: At Month 12
Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30794314Fleischer DM, Greenhawt M, Sussman G, Begin P, Nowak-Wegrzyn A, Petroni D, Beyer K, Brown-Whitehorn T, Hebert J, Hourihane JO, Campbell DE, Leonard S, Chinthrajah RS, Pongracic JA, Jones SM, Lange L, Chong H, Green TD, Wood R, Cheema A, Prescott SL, Smith P, Yang W, Chan ES, Byrne A, Assa'ad A, Bird JA, Kim EH, Schneider L, Davis CM, Lanser BJ, Lambert R, Shreffler W. Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial. JAMA. 2019 Mar 12;321(10):946-955. doi: 10.1001/jama.2019.1113.
- Results publication: PubMed 32502548Greenhawt M, Kim EH, Campbell DE, Green TD, Lambert R, Fleischer DM. Improvements in eliciting dose across baseline sensitivities following 12 months of epicutaneous immunotherapy (EPIT) in peanut-allergic children aged 4 to 11 years. J Allergy Clin Immunol Pract. 2020 Oct;8(9):3219-3221. doi: 10.1016/j.jaip.2020.05.030. Epub 2020 Jun 2. No abstract available.
- Derived from this study: PubMed 33259921Remington BC, Campbell DE, Green TD, Fleischer DM, Koppelman SJ. Post hoc analysis of epicutaneous immunotherapy for peanut allergy phase 3 results: Relevance for exposure through restaurant meals. Ann Allergy Asthma Immunol. 2021 Feb;126(2):208-209. doi: 10.1016/j.anai.2020.11.015. Epub 2020 Nov 28. No abstract available.
- Derived from this study: PubMed 31442495Remington BC, Krone T, Kim EH, Bird JA, Green TD, Lack G, Fleischer DM, Koppelman SJ. Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy. Ann Allergy Asthma Immunol. 2019 Nov;123(5):488-493.e2. doi: 10.1016/j.anai.2019.08.007. Epub 2019 Aug 20.
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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.
David M Fleischer, MD principal investigator
Children's Hospital Colorado
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viaskin Peanut 250mcg in people with Peanut Allergy, run by DBV Technologies at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, Australia, Germany, Ireland. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2021). 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?
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population (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 NCT02636699, which also lists 4 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 18 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.