Peanut AllergyPhase 2NCT03793608
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
A Phase 2 study testing Dupilumab in people with Peanut Allergy, run by Regeneron Pharmaceuticals at 9 sites in 2 countries.
Trial summary
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 12 Mar 2019to 12 May 2021
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient has a clinical history of allergy to peanuts or peanut-containing foods (symptom[s] of reaction due to exposure).
- Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening DBPCFC conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines. And not experiencing dose limiting symptoms to placebo
- Serum IgE to peanut of ≥10 kilo units (kUA)/L and/or a SPT to peanut ≥8 mm compared to a negative control
- Patients/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
- Patients with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study
Who cannot join
- Any previous exposure to marketed dupilumab or dupilumab in a clinical trial
- Member of the clinical site study team or his/her immediate family
- History of other chronic disease (other than asthma, AD, or allergic rhinitis) requiring therapy
- History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock as defined by more than 3 episodes of anaphylaxis within the past year and/or an episode of anaphylaxis within 60 days of screening DBPCFC
- History of eosinophilic gastrointestinal disease
- History of eosinophilic granulomatosis with polyangiitis
Show all 9Show fewer
- Severe, unstable asthma at time of enrollment or any patient with Forced Expiratory Volume in 1 Second (FEV1) <80% of predicted or asthma control questionnaire (ACQ)>1.5
- Use of systemic corticosteroids within 2 months prior to screening
- Note: Other protocol Inclusion/Exclusion Criteria apply
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Regeneron Investigational Site
Great Neck, New York, 11021
Regeneron Investigational Site
Indianapolis, Indiana, 46202
Regeneron Investigational Site
Mountain View, California, 94305
Regeneron Investigational Site
Tampa, Florida, 33612
Regeneron Investigational Site
The Bronx, New York, 10461
Regeneron Investigational Site
Ypsilanti, Michigan, 48197
Canada3 sites
Regeneron Investigational Site
Hamilton, Ontario, L8S 1G5
Regeneron Investigational Site
Montreal, Quebec, H3T 1C5
Regeneron Investigational Site
Toronto, Ontario, M5G 1X8
About this study
Official title: A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24.
The secondary objectives are:
- To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC
- To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients
- To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE)
- To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations
- To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time
- Conditions
- Peanut Allergy
- Being tested
- Dupilumab
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called REGN668, IL4R, Dupixent, SAR231893
Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Open label weight base subcutaneous (SC) injection every two (Q2) weeks. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.
Measured: At Week 24
Secondary outcomes (10)
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.
Measured: Weeks 24 and 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
Measured: At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.
Measured: At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
Measured: At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.
Measured: At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
Measured: At Week 36
Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.
Measured: Weeks 4, 8, 12, 16, 24, and 36
Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.
Measured: Weeks 4, 12, 24, and 36
Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.
Measured: At Week 24
Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24
Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start12 Mar 2019
- Primary completion19 Feb 2021
- Study completion12 May 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Regeneron 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793608
- Sponsor's protocol ID
- R668-ALG-1702
- Other IDs
- 2018-003133-15, 2018
- Status last verified
- May 2022
- First submitted
- 2 Jan 2019
- Last updated
- 19 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Sindher SB, Nadeau KC, Chinthrajah RS, Leflein JG, Begin P, Ohayon JA, Ponda P, Wambre E, Liu J, Khokhar FA, Akinlade B, Maloney J, Orengo JM, Hamilton JD, Kamal MA, Hooper AT, Patel N, Patel K, Laws E, Mannent LP, Radin AR. Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open-Label, Phase II Study. Allergy. 2025 Jan;80(1):227-237. doi: 10.1111/all.16404. Epub 2024 Dec 14.
PubMed 39673452Chinthrajah RS, Sindher SB, Nadeau KC, Leflein JG, Spergel JM, Petroni DH, Jones SM, Casale TB, Wang J, Carr WW, Shreffler WG, Wood RA, Wambre E, Liu J, Akinlade B, Atanasio A, Orengo JM, Hamilton JD, Kamal MA, Hooper AT, Patel K, Laws E, Mannent LP, Adelman DC, Ratnayake A, Radin AR. Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy. Allergy. 2025 Mar;80(3):827-842. doi: 10.1111/all.16420. Epub 2024 Dec 14.
PubMed 39673367Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
PubMed 38814736
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
- ClinicalTrials.gov ID
- NCT03793608
- Acronym / sponsor ID
- R668-ALG-1702
- Conditions
- Peanut Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Posted 19 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24.
The secondary objectives are:
- To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC
- To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients
- To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE)
- To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations
- To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabOpen label weight base subcutaneous (SC) injection every two (Q2) weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient has a clinical history of allergy to peanuts or peanut-containing foods (symptom[s] of reaction due to exposure).
- Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening DBPCFC conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines. And not experiencing dose limiting symptoms to placebo
- Serum IgE to peanut of ≥10 kilo units (kUA)/L and/or a SPT to peanut ≥8 mm compared to a negative control
- Patients/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
- Patients with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study
Key exclusion criteria (9 listed)
- Any previous exposure to marketed dupilumab or dupilumab in a clinical trial
- Member of the clinical site study team or his/her immediate family
- History of other chronic disease (other than asthma, AD, or allergic rhinitis) requiring therapy
- History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock as defined by more than 3 episodes of anaphylaxis within the past year and/or an episode of anaphylaxis within 60 days of screening DBPCFC
- History of eosinophilic gastrointestinal disease
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 |
|---|---|---|
| DupilumabAlso: REGN668, IL4R, Dupixent, SAR231893Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W) | Drug | Dupilumab |
Primary outcome
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24
Time frame: At Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.
10 secondary outcomes
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
Time frame: Weeks 24 and 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36
Time frame: At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
Time frame: At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
Time frame: At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
Time frame: At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36
Time frame: At Week 36
Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Time frame: Weeks 4, 8, 12, 16, 24, and 36
Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
Time frame: Weeks 4, 12, 24, and 36
Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24
Time frame: At Week 24
Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24
Time frame: At Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39673452Sindher SB, Nadeau KC, Chinthrajah RS, Leflein JG, Begin P, Ohayon JA, Ponda P, Wambre E, Liu J, Khokhar FA, Akinlade B, Maloney J, Orengo JM, Hamilton JD, Kamal MA, Hooper AT, Patel N, Patel K, Laws E, Mannent LP, Radin AR. Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open-Label, Phase II Study. Allergy. 2025 Jan;80(1):227-237. doi: 10.1111/all.16404. Epub 2024 Dec 14.
- Derived from this study: PubMed 39673367Chinthrajah RS, Sindher SB, Nadeau KC, Leflein JG, Spergel JM, Petroni DH, Jones SM, Casale TB, Wang J, Carr WW, Shreffler WG, Wood RA, Wambre E, Liu J, Akinlade B, Atanasio A, Orengo JM, Hamilton JD, Kamal MA, Hooper AT, Patel K, Laws E, Mannent LP, Adelman DC, Ratnayake A, Radin AR. Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy. Allergy. 2025 Mar;80(3):827-842. doi: 10.1111/all.16420. Epub 2024 Dec 14.
- Derived from this study: PubMed 38814736Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Peanut Allergy, run by Regeneron Pharmaceuticals at 9 sites in 2 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 5 inclusion and 9 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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. 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 19 May 2022). 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 Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24 (time frame: At Week 24). 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 NCT03793608, which also lists 3 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 19 May 2022.