Eosinophilic EsophagitisPhase 2SMILEENCT02579876
Milk Patch for Eosinophilic Esophagitis
A Phase 2 study testing Viaskin Milk 500 mcg in people with Eosinophilic Esophagitis and Milk Allergy, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Eosinophilic Esophagitis, Milk Allergy
- What is being tested?
- Viaskin Milk 500 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 20 Nov 2018
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Well-documented medical history of Eosinophilic Esophagitis after ingestion of milk and currently following a strict milk-free diet.
- Upper endoscopy and biopsy at initial clinical evaluation during Visit 2 showing greater than 15 eosinophils/high power field (HPF) isolated to the esophagus meeting the consensus diagnosis of Eosinophilic Esophagitis, after milk was re-introduced into the subject's diet (30 ml/day for 1 week to 2 months), while the subject was on proton pump inhibitor.
- Upper endoscopy and biopsy at second clinical evaluation during Visit 3 showing less than 5 eosinophils per HPF isolated to the esophagus after a minimum of 6 weeks under milk-free diet, and while the subject is on proton pump inhibitor.
- Negative pregnancy test for female subjects of childbearing potential. Females of childbearing potential must use effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 18 years of age.
- Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
- Signed informed consent from parent(s)/guardian(s) of children < 18 years + children's assent.
- Subjects agree to maintain a constant diet during the trial, with the exception of milk.
- Subjects will maintain constant medications for asthma and allergic rhinitis during the trial.
Who cannot join
- Subjects with a history of severe anaphylaxis to milk with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence), Quincke Edema or requiring intubation.
- Active IgE- mediated milk allergy.
- Pregnancy or lactation.
- Subjects with other eosinophilic gastrointestinal disorders.
- Subjects on swallowed corticosteroids or anti-leukotrienes for Eosinophilic Esophagitis.
- Subjects with symptomatic allergy to pollens whose symptoms during the corresponding pollen season might interfere with the recording of symptoms during the upper endoscopy/biopsy, if the upper endoscopy/biopsy is conducted during the pollen season. The Investigator will have to ensure that the period for conducting the upper endoscopy for such a subject will be outside of the pollen season.
Show all 23Show fewer
- Subjects treated with systemic long-acting corticosteroids (depot corticosteroids) within 12 weeks prior to Visit 1 and/or systemic short-acting corticosteroid within 4 weeks prior to Visit 1 or any systemic corticosteroid at screening.
- Subjects with asthma conditions defined as follows:
- Uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007).
- at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months;
- prior intubation for asthma in the past two years.
- Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Subjects undergoing any type of immunotherapy to any food within one year prior to Visit 1.
- Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue.
- Subjects currently treated with anti-tumor necrosis factor drugs or anti-Immunoglobulin E (IgE) drugs or any biologic immunomodulatory therapy within one year prior to Visit 1.
- Allergy or known hypersensitivity to placebo excipients either of the Viaskin® or Tegaderm®.
- Subjects suffering from generalized dermatologic diseases with no intact skin zones to apply the Viaskin®, or urticarial and mast cell disorders such as chronic idiopathic urticaria.
- Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper endoscopy and biopsy.
- Past or current disease(s), which in the opinion the sponsor-investigator, may affect the subject's participation in this study including but not limited to active autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders).
- Any history of drug or alcohol abuse in the past five years.
- Subjects unable to follow the protocol and the protocol requirements.
- Participation in another clinical intervention study in the three months prior to Study Visit 1.
- Subjects on any experimental drugs or treatments.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.
Read the detailed description
This is a double-blind, placebo-controlled, randomized trial to study the efficacy and safety of Viaskin® Milk, an allergen extract of milk administered epicutaneously using the Viaskin® epicutaneous delivery system (EPIT) in subjects from 4 to 17 years old with a milk induced Eosinophilic Esophagitis. Subjects will be randomized in a 3:1 ratio into two different treatment groups, to receive EPIT with Viaskin® Milk (500 µg of milk proteins) or placebo.
Subjects who complete the double-blind treatment period (approximately 11 months), will automatically rollover into an open label treatment period (additional 11 months). All subjects will receive the 500 µg (micrograms) Viaskin Milk patch.
- Conditions
- Eosinophilic Esophagitis, Milk Allergy
- Being tested
- Viaskin Milk 500 mcg, Viaskin Placebo
- Keywords
- Milk Allergy, Viaskin Milk, Epicutaneous ImmunoTherapy (EPIT), Eosinophilic Esophagitis, Milk-Induced Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin Milk 500 mcgDrug
Also called Milk Patch, Viaskin Epicutaneous ImmunoTherapy (EPIT)
Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Viaskin PlaceboDrug
Also called Placebo Patch, Placebo Epicutaneous ImmunoTherapy (EPIT)
Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
| Study group | Role | What they receive |
|---|---|---|
| Viaskin Milk 500 mcg | Active comparator | Viaskin patch containing milk protein. The patch is applied to the skin Receives: Drug: Viaskin Milk 500 mcg |
| Viaskin Placebo | Placebo comparator | Viaksin patch without any milk protein. Receives: Drug: Viaskin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population)
Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels).
The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.
Measured: From baseline to month 11 (end of double blind phase)
Change in Eosinophils/High Power Field at End of Double-blind (DB) (Per Protocol Patients)
Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels).
The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.
Measured: Month 11(end of double blind phase)
Secondary outcomes (6)
Eosinophilic Esophagitis Symptom Score (Intent to Treat Population)
Symptoms of Eosinophilic Esophagitis range from abdominal pain, gastroesophageal reflux, vomiting, and difficult swallowing. Investigator assessment of the subject's symptoms was completed on a 4-point Likert scale for 3 separate symptoms (vomiting, abdominal pain and dysphagia).
Investigator assessment of the subject's symptoms was completed on a 4-point Likert scale for 3 separate symptoms (vomiting, abdominal pain and dysphagia). (0-none, 1-mild, 2-moderate, 3-severe, ). Total score is reported with a range of 0 to 9. A lower score is better.
Measured: Total Symptom Score at End of DB Phase, Month 11
Esophageal Endoscopy Score (ITT)
Upper endoscopies with biopsies (2 each of proximal and distal, plus any inflamed areas) will be completed before and after each treatment period. Each endoscopy will be scored using a validated standardized measure which examines 4 major esophageal features (rings, furrows, exudates and edema) and the presence of minor features of narrow caliber esophagus, feline esophagus, stricture and crepe paper esophagus. Each feature is graded: 0-none, 1 mild, 2-moderate, 3-severe. The scores are summed including both minor and major criteria.
Total score is presented and lower score is better. The range is from 0-12
Measured: At end of DB phase, at 11 months
Eosinophils Per HPF at End of Double Bind Protocol (Per Protocol) Patients
Maximum Eosinophils/HPF after milk reintroduction at the end of double bind phase
Measured: End of DB Phase, at 11 months
Pediatric Eosinophilic Esophagitis Symptom Score (ITT)
Measure of Pediatric Eosinophilic Esophagitis symptom Score (PEESS) at the end of DB phase for the Intent to Treat Population The PEESS® is a 20 question survey asking patient symptom intensity and frequency on a 5 point scale (0 to 4) for each question for the preceding month. Therefore, the total score can range from 0 to 80. The total score is reported and lower score is better
Measured: Month 11, end of Double Blind Phase
Endoscopy Score (Per Protocol Patients)
Upper endoscopies with biopsies (2 each of proximal and distal, plus any inflamed areas) will be completed before and after each treatment period. Each endoscopy will be scored using a validated standardized measure which examines 4 major esophageal features (rings, furrows, exudates and edema) and the presence of minor features of narrow caliber esophagus, feline esophagus, stricture and crepe paper esophagus. Each feature is graded: 0-none, 1 mild, 2-moderate, 3-severe. The scores including both major and minor criteria are summed.
Total score is presented and lower score is better. The range is from 0-12
Measured: Month 11 (end of double blind phase)
Pediatric Eosinophil Esophagitis Symptom Score (PP Population)
Pediatric Eosinophilic Esophagitis Symptom Score at end of DB phase using the validated Pediatric Eosinophilic Esophagitis Symptom Score (PEESS).The PEESS® is a 20 question survey asking patient symptom intensity and frequency on a 5 point scale (0 to 4) for each question for the preceding month. Therefore, the total score can range from 0 to 80. The total score is reported and lower score is better.
Measured: Month 11, End of Double Blind Placebo Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion20 Dec 2017
- Study completion20 Nov 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- DBV Technologies
- Responsible party
- Principal investigator, Antonella Cianferoni, Children's Hospital of Philadelphia
- Investigators
- Antonella Cianferoni, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579876
- Sponsor's protocol ID
- 13-010148
- Acronym
- SMILEE
- Status last verified
- Jun 2019
- First submitted
- 14 Oct 2015
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Spergel JM, Elci OU, Muir AB, Liacouras CA, Wilkins BJ, Burke D, Lewis MO, Brown-Whitehorn T, Cianferoni A. Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2020 Feb;18(2):328-336.e7. doi: 10.1016/j.cgh.2019.05.014. Epub 2019 May 14.
PubMed 31100455
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children
- ClinicalTrials.gov ID
- NCT02579876
- Acronym / sponsor ID
- SMILEE / 13-010148
- Conditions
- Eosinophilic Esophagitis, Milk Allergy
- Keywords
- Milk Allergy, Viaskin Milk, Epicutaneous ImmunoTherapy (EPIT), Eosinophilic Esophagitis, Milk-Induced Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- DBV Technologies
- Study start
- Oct 2015
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.
Detailed description
This is a double-blind, placebo-controlled, randomized trial to study the efficacy and safety of Viaskin® Milk, an allergen extract of milk administered epicutaneously using the Viaskin® epicutaneous delivery system (EPIT) in subjects from 4 to 17 years old with a milk induced Eosinophilic Esophagitis. Subjects will be randomized in a 3:1 ratio into two different treatment groups, to receive EPIT with Viaskin® Milk (500 µg of milk proteins) or placebo.
Subjects who complete the double-blind treatment period (approximately 11 months), will automatically rollover into an open label treatment period (additional 11 months). All subjects will receive the 500 µg (micrograms) Viaskin Milk patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viaskin Milk 500 mcg | Active comparator | Drug: Viaskin Milk 500 mcgViaskin patch containing milk protein. The patch is applied to the skin |
| Viaskin Placebo | Placebo comparator | Drug: Viaskin PlaceboViaksin patch without any milk protein. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Well-documented medical history of Eosinophilic Esophagitis after ingestion of milk and currently following a strict milk-free diet.
- Upper endoscopy and biopsy at initial clinical evaluation during Visit 2 showing greater than 15 eosinophils/high power field (HPF) isolated to the esophagus meeting the consensus diagnosis of Eosinophilic Esophagitis, after milk was re-introduced into the subject's diet (30 ml/day for 1 week to 2 months), while the subject was on proton pump inhibitor.
- Upper endoscopy and biopsy at second clinical evaluation during Visit 3 showing less than 5 eosinophils per HPF isolated to the esophagus after a minimum of 6 weeks under milk-free diet, and while the subject is on proton pump inhibitor.
- Negative pregnancy test for female subjects of childbearing potential. Females of childbearing potential must use effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 18 years of age.
- Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
Key exclusion criteria (23 listed)
- Subjects with a history of severe anaphylaxis to milk with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence), Quincke Edema or requiring intubation.
- Active IgE- mediated milk allergy.
- Pregnancy or lactation.
- Subjects with other eosinophilic gastrointestinal disorders.
- Subjects on swallowed corticosteroids or anti-leukotrienes for Eosinophilic Esophagitis.
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 Milk 500 mcgAlso: Milk Patch, Viaskin Epicutaneous ImmunoTherapy (EPIT)Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins. | Drug | Viaskin Milk 500 mcg |
| Viaskin PlaceboAlso: Placebo Patch, Placebo Epicutaneous ImmunoTherapy (EPIT)Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation. | Drug | Viaskin Placebo |
Primary outcome
Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population)
Time frame: From baseline to month 11 (end of double blind phase)
Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels). The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.
Change in Eosinophils/High Power Field at End of Double-blind (DB) (Per Protocol Patients)
Time frame: Month 11(end of double blind phase)
Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels). The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.
6 secondary outcomes
Eosinophilic Esophagitis Symptom Score (Intent to Treat Population)
Time frame: Total Symptom Score at End of DB Phase, Month 11
Esophageal Endoscopy Score (ITT)
Time frame: At end of DB phase, at 11 months
Eosinophils Per HPF at End of Double Bind Protocol (Per Protocol) Patients
Time frame: End of DB Phase, at 11 months
Pediatric Eosinophilic Esophagitis Symptom Score (ITT)
Time frame: Month 11, end of Double Blind Phase
Endoscopy Score (Per Protocol Patients)
Time frame: Month 11 (end of double blind phase)
Pediatric Eosinophil Esophagitis Symptom Score (PP Population)
Time frame: Month 11, End of Double Blind Placebo Control
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31100455Spergel JM, Elci OU, Muir AB, Liacouras CA, Wilkins BJ, Burke D, Lewis MO, Brown-Whitehorn T, Cianferoni A. Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2020 Feb;18(2):328-336.e7. doi: 10.1016/j.cgh.2019.05.014. Epub 2019 May 14.
- Individual participant dataSharing planned: No
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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.
Antonella Cianferoni, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viaskin Milk 500 mcg in people with Eosinophilic Esophagitis and Milk Allergy, run by Children's Hospital of Philadelphia at 1 site 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 8 inclusion and 23 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 10 Jul 2019). 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?
Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population) (time frame: From baseline to month 11 (end of double blind phase)). The study lists 2 primary outcomes in all. 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 NCT02579876, which also lists 1 linked publication.
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 10 Jul 2019.