Cow's Milk AllergyPhase 2NCT03462030
Baked Milk Oral Immunotherapy for Cow's Milk Allergy
A Phase 2 study testing Baked non-fat cow's milk powder in people with Cow's Milk Allergy, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Baked non-fat cow's milk powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 19 Feb 2024
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
- Are age 3-18 years, either sex, any ethnicity or race
- Provide signed informed consent by parent or legal guardian and informed assent if applicable
- Have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticarial, upper or lower respiratory symptoms, gastrointestinal disturbances, rash, oral symptoms)
- Have a skin prick test positive to milk (diameter of wheal 3 mm ≥ negative control) and serum milk-specific immunoglobulin E (IgE) level >5 kilo Units (kU)/L within the past 6-12 months
- Have a positive reaction to a cumulative dose of ≤444 mg of baked milk powder in the initial qualifying double blind placebo-controlled food challenge.
- Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- Have self-injectable epinephrine available at all times
Who cannot join
- Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
- Have a history of severe anaphylaxis resulting in hypotension, neurological compromise, or mechanical ventilation
- Have a history of intubation related to asthma
- Tolerate more than 444 mg of baked milk powder at the initial qualifying double blind placebo controlled food challenge.
- Allergy to placebo ingredients or reacts to any dose of placebo during the qualifying oral food challenge.
- Poor control of atopic dermatitis
Show all 26Show fewer
- Are unable to tolerate at least 3 mg of baked milk protein on dose escalation day
- Are pregnant or lactating
- Have severe asthma defined by 2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5 or 6
- Have severe or poorly controlled asthma defined by with any of the following criteria:
- Forced expiratory volume in 1 second (FEV1) <80% of predicted
- Inhaled corticosteroid dosing dosing of >500 mcg daily of fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
- ≥ 1 hospitalization in the past year for asthma or
- > 1 emergency department visit in the past 6 months for asthma
- Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or intravenous or oral corticosteroid burst) in the following manners: History of daily oral steroid dosing within 4 weeks prior to baseline visit or for > 1 month during the past year or >2 burst oral steroid courses in the past 6 months.
- Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
- Are receiving omalizumab, mepolizumab, beta- blocker, angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blockers, calcium channel blockers, or tricyclic antidepressant therapy
- Have used immunomodulatory therapy (not including corticosteroids) or biologic therapy within the past year
- Have participated in any interventional study for treatment of a food allergy in the past 6 months
- Are on 'build up phase' of environmental allergen immunotherapy. Subjects tolerating maintenance allergen immunotherapy can be enrolled.
- Have a history of eosinophilic esophagitis in the past 3 years
- Have a chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Have used an investigational drug within 90 days or plan to use an investigational drug during the study period
- Severe reaction at initial double blind placebo controlled food challenge, defined as:
- Life-threatening anaphylaxis
- Requiring overnight hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy
The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.
Read the detailed description
This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.
- Conditions
- Cow's Milk Allergy
- Being tested
- Baked non-fat cow's milk powder, Placebo: Tapioca Powder
- Keywords
- food allergy, oral immunotherapy
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baked non-fat cow's milk powderDrug
Also called Investigational New Drug (IND) 17114
Oral immunotherapy with increasing quantities of baked milk.
Placebo: Tapioca PowderDrug
Placebo control.
| Study group | Role | What they receive |
|---|---|---|
| Baked Milk Immunotherapy | Experimental | Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period. Receives: Drug: Baked non-fat cow's milk powder |
| Placebo | Placebo comparator | Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period. Receives: Drug: Placebo: Tapioca Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.
Measured: 1 year
Secondary outcomes (7)
Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
The investigators will perform baked milk challenges to 4044 mg of baked milk protein and calculate the proportion of subjects who tolerate 4 grams of baked milk protein after one year of baked milk oral immunotherapy. This measure reports the number of participants that were able to tolerate 4 grams of baked milk protein.
Measured: 1 year
Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
The investigators will perform unheated milk challenges to up to 8000 mg of unheated milk protein and calculate the proportion of subjects who tolerate 2 grams of unheated milk protein after 2 years of treatment. This measure reports the number of participants that were able to tolerate 2 grams of unheated milk protein.
Measured: 2 years
Change in Maximum Tolerated Dose of Baked Milk
Change in maximum tolerated dose (milligrams) of baked milk from baseline to end of year 1 and end of year 2.
Measured: Baseline, 1 year and 2 years
Change in Milk-specific IgE Level
Change in milk-specific immunoglobulin E (IgE) level measured in kU/L.
Measured: Baseline and up to year 2
Change in Milk-specific IgG4 Level
Change in milk-specific immunoglobulin G4 (IgG4) level measured in mg/L.
Measured: Baseline and up to year 2
Change in Milk Skin Prick Test Responses
Change in milk skin prick test responses measured as a change in wheal size in millimeters.
Measured: Baseline and up to year 2
Change in Quality of Life as Assessed by the Food Allergy Questionnaire
The food allergy questionnaire has an overall score range of 0-6 with 6 indicating the worst quality of life.
Measured: Baseline and up to year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start15 Mar 2018
- Primary completion25 Jan 2021
- Study completion19 Feb 2024
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 (33)Papers the sponsor has linked to this study.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Myra Reinhardt Foundation, La Jolla Institute for Allergy & Immunology
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462030
- Sponsor's protocol ID
- IRB00099590
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2018
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. Nutr Res. 2011 Jan;31(1):61-75. doi: 10.1016/j.nutres.2011.01.001. No abstract available.
PubMed 21310308Gupta RS, Springston EE, Warrier MR, Smith B, Kumar R, Pongracic J, Holl JL. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011 Jul;128(1):e9-17. doi: 10.1542/peds.2011-0204. Epub 2011 Jun 20.
PubMed 21690110Chafen JJ, Newberry SJ, Riedl MA, Bravata DM, Maglione M, Suttorp MJ, Sundaram V, Paige NM, Towfigh A, Hulley BJ, Shekelle PG. Diagnosing and managing common food allergies: a systematic review. JAMA. 2010 May 12;303(18):1848-56. doi: 10.1001/jama.2010.582.
PubMed 20460624Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014 Feb;133(2):291-307; quiz 308. doi: 10.1016/j.jaci.2013.11.020. Epub 2013 Dec 31.
PubMed 24388012Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1.
PubMed 17935766Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
PubMed 23273958Kim J, Kwon J, Noh G, Lee SS. The effects of elimination diet on nutritional status in subjects with atopic dermatitis. Nutr Res Pract. 2013 Dec;7(6):488-94. doi: 10.4162/nrp.2013.7.6.488. Epub 2013 Nov 29.
PubMed 24353835Hobbs CB, Skinner AC, Burks AW, Vickery BP. Food allergies affect growth in children. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):133-4.e1. doi: 10.1016/j.jaip.2014.11.004. Epub 2014 Nov 25.
PubMed 25577638Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010 Aug;65(8):933-45. doi: 10.1111/j.1398-9995.2010.02342.x. Epub 2010 Feb 22.
PubMed 20180792Flokstra-de Blok BM, Dubois AE, Vlieg-Boerstra BJ, Oude Elberink JN, Raat H, DunnGalvin A, Hourihane JO, Duiverman EJ. Health-related quality of life of food allergic patients: comparison with the general population and other diseases. Allergy. 2010 Feb;65(2):238-44. doi: 10.1111/j.1398-9995.2009.02121.x. Epub 2009 Oct 1.
PubMed 19796214Eigenmann PA, Caubet JC, Zamora SA. Continuing food-avoidance diets after negative food challenges. Pediatr Allergy Immunol. 2006 Dec;17(8):601-5. doi: 10.1111/j.1399-3038.2006.00455.x.
PubMed 17121588Burbank AJ, Sood P, Vickery BP, Wood RA. Oral Immunotherapy for Food Allergy. Immunol Allergy Clin North Am. 2016 Feb;36(1):55-69. doi: 10.1016/j.iac.2015.08.007.
PubMed 26617227Nowak-Wegrzyn A, Bloom KA, Sicherer SH, Shreffler WG, Noone S, Wanich N, Sampson HA. Tolerance to extensively heated milk in children with cow's milk allergy. J Allergy Clin Immunol. 2008 Aug;122(2):342-7, 347.e1-2. doi: 10.1016/j.jaci.2008.05.043. Epub 2008 Jul 11.
PubMed 18620743Kim JS, Nowak-Wegrzyn A, Sicherer SH, Noone S, Moshier EL, Sampson HA. Dietary baked milk accelerates the resolution of cow's milk allergy in children. J Allergy Clin Immunol. 2011 Jul;128(1):125-131.e2. doi: 10.1016/j.jaci.2011.04.036. Epub 2011 May 23.
PubMed 21601913Oppenheimer JJ, Nelson HS, Bock SA, Christensen F, Leung DY. Treatment of peanut allergy with rush immunotherapy. J Allergy Clin Immunol. 1992 Aug;90(2):256-62. doi: 10.1016/0091-6749(92)90080-l.
PubMed 1500630
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT03462030
- Acronym / sponsor ID
- IRB00099590
- Conditions
- Cow's Milk Allergy
- Keywords
- food allergy, oral immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Myra Reinhardt Foundation, La Jolla Institute for Allergy & Immunology
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.
Detailed description
This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.
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 |
|---|---|---|
| Baked Milk Immunotherapy | Experimental | Drug: Baked non-fat cow's milk powderSubjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period. |
| Placebo | Placebo comparator | Drug: Placebo: Tapioca PowderSubjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
Key exclusion criteria (26 listed)
- Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
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 |
|---|---|---|
| Baked non-fat cow's milk powderAlso: Investigational New Drug (IND) 17114Oral immunotherapy with increasing quantities of baked milk. | Drug | Baked Milk Immunotherapy |
| Placebo: Tapioca PowderPlacebo control. | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 year
Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.
7 secondary outcomes
Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
Time frame: 1 year
Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
Time frame: 2 years
Change in Maximum Tolerated Dose of Baked Milk
Time frame: Baseline, 1 year and 2 years
Change in Milk-specific IgE Level
Time frame: Baseline and up to year 2
Change in Milk-specific IgG4 Level
Time frame: Baseline and up to year 2
Change in Milk Skin Prick Test Responses
Time frame: Baseline and up to year 2
Change in Quality of Life as Assessed by the Food Allergy Questionnaire
Time frame: Baseline and up to year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21310308Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. Nutr Res. 2011 Jan;31(1):61-75. doi: 10.1016/j.nutres.2011.01.001. No abstract available.
- Background: PubMed 21690110Gupta RS, Springston EE, Warrier MR, Smith B, Kumar R, Pongracic J, Holl JL. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011 Jul;128(1):e9-17. doi: 10.1542/peds.2011-0204. Epub 2011 Jun 20.
- Background: PubMed 20460624Chafen JJ, Newberry SJ, Riedl MA, Bravata DM, Maglione M, Suttorp MJ, Sundaram V, Paige NM, Towfigh A, Hulley BJ, Shekelle PG. Diagnosing and managing common food allergies: a systematic review. JAMA. 2010 May 12;303(18):1848-56. doi: 10.1001/jama.2010.582.
- Background: PubMed 24388012Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014 Feb;133(2):291-307; quiz 308. doi: 10.1016/j.jaci.2013.11.020. Epub 2013 Dec 31.
- Background: PubMed 17935766Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1.
- Background: PubMed 23273958Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
- Background: PubMed 24353835Kim J, Kwon J, Noh G, Lee SS. The effects of elimination diet on nutritional status in subjects with atopic dermatitis. Nutr Res Pract. 2013 Dec;7(6):488-94. doi: 10.4162/nrp.2013.7.6.488. Epub 2013 Nov 29.
- Background: PubMed 25577638Hobbs CB, Skinner AC, Burks AW, Vickery BP. Food allergies affect growth in children. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):133-4.e1. doi: 10.1016/j.jaip.2014.11.004. Epub 2014 Nov 25.
- Background: PubMed 20180792Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010 Aug;65(8):933-45. doi: 10.1111/j.1398-9995.2010.02342.x. Epub 2010 Feb 22.
- Background: PubMed 19796214Flokstra-de Blok BM, Dubois AE, Vlieg-Boerstra BJ, Oude Elberink JN, Raat H, DunnGalvin A, Hourihane JO, Duiverman EJ. Health-related quality of life of food allergic patients: comparison with the general population and other diseases. Allergy. 2010 Feb;65(2):238-44. doi: 10.1111/j.1398-9995.2009.02121.x. Epub 2009 Oct 1.
- Background: PubMed 17121588Eigenmann PA, Caubet JC, Zamora SA. Continuing food-avoidance diets after negative food challenges. Pediatr Allergy Immunol. 2006 Dec;17(8):601-5. doi: 10.1111/j.1399-3038.2006.00455.x.
- Background: PubMed 26617227Burbank AJ, Sood P, Vickery BP, Wood RA. Oral Immunotherapy for Food Allergy. Immunol Allergy Clin North Am. 2016 Feb;36(1):55-69. doi: 10.1016/j.iac.2015.08.007.
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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.
Robert Wood, MD principal investigator
Johns Hopkins University
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 Baked non-fat cow's milk powder in people with Cow's Milk Allergy, run by Johns Hopkins University 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 26 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 4 Feb 2025. 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 3 Dec 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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: 1 year). 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 NCT03462030, which also lists 33 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 4 Feb 2025.