Atopic DermatitisPhase 4NCT03356977
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
A Phase 4 study testing Crisaborole ointment 2% in people with Atopic Dermatitis, run by Pfizer at 32 sites in 3 countries.
Trial summary
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD. Read more about this study
- Who is it for?
- Ages 3 to 23 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Crisaborole ointment 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 16 Jan 2018to 12 Apr 2019
- Phase
- Phase 4
- 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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
Who cannot join
- Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States23 sites
DermResearch, Inc.
Austin, Texas, 78759
Craig A. Spiegel, M.D.
Bridgeton, Missouri, 63044
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
Pediatric Associates of Charlottesville, PLC
Charlottesville, Virginia, 22902
Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville, Virginia, 22902
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, 45414
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Tanner Clinic
Layton, Utah, 84041
DS Research
Louisville, Kentucky, 40241
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
Skin Specialists, PC
Omaha, Nebraska, 68144
Oregon Health & Science University
Portland, Oregon, 97239
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, California, 92123
Rady Children's Hospital
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94115
Timber Lane Allergy & Asthma Research, LLC
South Burlington, Vermont, 05403
Dermatology Specialists of Spokane
Spokane, Washington, 99202
IMMUNOe Research Centers
Thornton, Colorado, 80233
Oklahoma State University - Center for Health Sciences
Tulsa, Oklahoma, 74127
Jordan Valley Dermatology Center
West Jordan, Utah, 84088
Australia6 sites
The Skin Centre
Benowa, Queensland, 4217
Eastern Health
Box Hill, Victoria, 3128
Sinclair Dermatology
East Melbourne, Victoria, 3002
Australian Clinical Research Network Pty Ltd
Maroubra, New South Wales, 2035
The Royal Children's Hospital
Parkville, Victoria, 3052
Veracity Clinical Research
Woolloongabba, Queensland, 4102
Canada3 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
About this study
Official title: A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Read the detailed description
Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.
In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.
Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).
- Conditions
- Atopic Dermatitis
- Being tested
- Crisaborole ointment 2%
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole ointment 2%Drug
Also called Eucrisa
Applied BID
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole ointment 2% | Experimental | Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment. Receives: Drug: Crisaborole ointment 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.
Measured: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (<) 55 cm and greater than (>) 92.5 cm.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (<=) 4.5 kg and >15 kg.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (>=) 30 mmHg increase from baseline (IFB) and SBP change of >= 30 mmHg decrease from baseline (DFB); DBP: change of >=20 mmHg IFB and DBP change of >=20 mmHg DFB.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was <90 bpm and >180 bpm.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was < 22 breaths per min and > 53 breaths per min.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
Body temperature of participants was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) > 30 msec. IFB stands for increase from baseline.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
Criteria: hematology: hemoglobin, hematocrit, erythrocytes < 0.8*lower limit of normal (LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN), leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, bicarbonate <0.9* LLN >1.1* ULN, glucose <0.6*LLN >1.5*ULN.
Measured: Baseline (Day 1) up to Day 29 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start16 Jan 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
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 Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356977
- Sponsor's protocol ID
- C3291002
- Other IDs
- CARE 1
- Status last verified
- Sep 2019
- First submitted
- 31 Oct 2017
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6.
PubMed 32212104
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT03356977
- Acronym / sponsor ID
- C3291002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Detailed description
Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.
In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.
Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crisaborole ointment 2% | Experimental | Drug: Crisaborole ointment 2%Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment. |
Who may qualify
- Ages
- 3 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
Key exclusion criteria (1 listed)
- Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
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 |
|---|---|---|
| Crisaborole ointment 2%Also: EucrisaApplied BID | Drug | Crisaborole ointment 2% |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
Time frame: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (<) 55 cm and greater than (>) 92.5 cm.
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (<=) 4.5 kg and >15 kg.
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (>=) 30 mmHg increase from baseline (IFB) and SBP change of >= 30 mmHg decrease from baseline (DFB); DBP: change of >=20 mmHg IFB and DBP change of >=20 mmHg DFB.
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was <90 bpm and >180 bpm.
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was < 22 breaths per min and > 53 breaths per min.
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Body temperature of participants was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) > 30 msec. IFB stands for increase from baseline.
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Criteria: hematology: hemoglobin, hematocrit, erythrocytes < 0.8*lower limit of normal (LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN), leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, bicarbonate <0.9* LLN >1.1* ULN, glucose <0.6*LLN >1.5*ULN.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32212104Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crisaborole ointment 2% in people with Atopic Dermatitis, run by Pfizer at 32 sites in 3 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 1 inclusion and 1 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Australia, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Oct 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?
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions (time frame: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)). The study lists 9 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 NCT03356977, 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 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.