Dermatitis AtopicPhase 1NCT04135560

A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants

A Phase 1 study of Dermatitis Atopic, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Dermatitis Atopic
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2019to 10 Apr 2020
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female participants of non-childbearing potential and/or male participants who, at the time of screening, must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD):
Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Participants enrolling as Japanese in Part B must have 4 biologically Japanese grandparents who were born in Japan.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Who cannot join

Participants who have any visible skin damage or skin condition (eg sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
Participants who have a history of or have active AD/eczema/urticaria.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.

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Have undergone significant trauma or major surgery within 4 weeks of screening.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.5 for additional details).
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
A positive urine drug test.
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN);
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of serious adverse reactions or hypersensitivity to any topical drug; or known allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the PF-07038124 IB.
Not willing to refrain from shaving, the use of depilatories or other hair-removal activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the treatment areas for 48 hours prior to admission to the CRU and for the duration of the stay in the CRU.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN, LOCAL TOLERABILITY AND DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE-DOSE, TOPICAL ADMINISTRATION OF PF-07038124 TO HEALTHY PARTICIPANTS

The purpose of this study is to evaluate the skin irritation potential of PF-07038124 ointment and vehicle (placebo) in Part A following multiple-doses applied topically to healthy participants. In Part B, the safety, tolerability, pharmacokinetic (PK), and skin irritation potential of PF-07038124 will be evaluated. In Part A, the highest concentration of 0.06% PF-07038124 will be applied to normal skin with a small surface area of 20 cm2 (0.1% body surface area [BSA]), while Part B will evaluate application of PF-07038124 and vehicle (placebo) to a surface area of 2000 cm2 (10% BSA) and 4000 cm2 (20% BSA). These data will provide support for clinical development in participants with mild to moderate AD.

Conditions: Dermatitis Atopic
Being tested: PF-07038124 and Vehicle, PF-07038124 or vehicle
Keywords: Eczema
Medical subject headings: Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07038124 and VehicleDrug
PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)
PF-07038124 or vehicleDrug
PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA
PF-07038124 or vehicleDrug
PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA
PF-07038124 or vehicleDrug
PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA
PF-07038124 or vehicleDrug
PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA
PF-07038124 or vehicleDrug
PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA
PF-07038124 or vehicleDrug
PF-07038124 safe concentration or vehicle BID applied to 10% BSA

Study groups in NCT04135560
Study group	Role	What they receive
Part A Cohort 1 (1% Body Surface Area)	Experimental	Each participant in this cohort will receive both PF-07038124 0.06% and vehicle applied to the skin (1% Body Surface Area) Receives: Drug: PF-07038124 and Vehicle
Part B Cohort 1 (10% Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle
Part B Cohort 2 (10% Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle
Part B Cohort 3 (10% Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle
Part B Cohort 4 (10% Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle
Part B Cohort 5 (20% Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle
Part B Cohort 6 (10% Body Surface Area)	Experimental	Optional cohort of Japanese participants Receives: Drug: PF-07038124 or vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Number of Participants with Treatment Emergent Treatment-Related Adverse Evenst (AEs)
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Measured: through study completion, up to 38 days
Part A: Number of Adverse Events by Severity
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Measured: through study completion, up to 38 days
Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs.
Incidence and severity of local skin irritation.
Measured: through study completion, up to 41 days
Part B: Number of Adverse Events by Severity
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs.
Incidence and severity of local skin irritation.
Measured: through study completion, up to 41 days

Secondary outcomes (5)

Part B: Maximum Observed Plasma Concentration (Cmax)
Measured: Days 1 and 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Days 1 and 10
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Measured: Days 1 and 10
Plasma Decay Half-Life (t1/2)
Measured: Days 1 and 10
Average Concentration at Steady State (Cav)
Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201910 Apr 2020

First posted22 Oct 2019
Study start29 Oct 2019
Primary completion10 Apr 2020
Study completion10 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dermatitis AtopicStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04135560
Sponsor's protocol ID: C3941001
Other IDs: FIH Study of PF-07038124
Status last verified: May 2020
First submitted: 7 Oct 2019
Last updated: 14 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

All Dermatitis Atopic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN, LOCAL TOLERABILITY AND DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE-DOSE, TOPICAL ADMINISTRATION OF PF-07038124 TO HEALTHY PARTICIPANTS
ClinicalTrials.gov ID: NCT04135560
Acronym / sponsor ID: C3941001
Conditions: Dermatitis Atopic
Keywords: Eczema
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 29 Oct 2019 (actual)
Primary completion: 10 Apr 2020 (actual)
Study completion: 10 Apr 2020 (actual)
First posted: 22 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Part A Cohort 1 (1% Body Surface Area)	Experimental	Drug: PF-07038124 and VehicleEach participant in this cohort will receive both PF-07038124 0.06% and vehicle applied to the skin (1% Body Surface Area)
Part B Cohort 1 (10% Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle
Part B Cohort 2 (10% Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle
Part B Cohort 3 (10% Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle
Part B Cohort 4 (10% Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle
Part B Cohort 5 (20% Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle
Part B Cohort 6 (10% Body Surface Area)	Experimental	Drug: PF-07038124 or vehicleOptional cohort of Japanese participants

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy female participants of non-childbearing potential and/or male participants who, at the time of screening, must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD):
Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Participants enrolling as Japanese in Part B must have 4 biologically Japanese grandparents who were born in Japan.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (19 listed)

Participants who have any visible skin damage or skin condition (eg sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
Participants who have a history of or have active AD/eczema/urticaria.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

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
PF-07038124 and VehiclePF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)	Drug	Part A Cohort 1 (1% Body Surface Area)
PF-07038124 or vehiclePF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA	Drug	Part B Cohort 1 (10% Body Surface Area)
PF-07038124 or vehiclePF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA	Drug	Part B Cohort 2 (10% Body Surface Area)
PF-07038124 or vehiclePF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA	Drug	Part B Cohort 3 (10% Body Surface Area)
PF-07038124 or vehiclePF-07038124 0.06% or vehicle ointment BID applied to 10% BSA	Drug	Part B Cohort 4 (10% Body Surface Area)
PF-07038124 or vehiclePF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA	Drug	Part B Cohort 5 (20% Body Surface Area)
PF-07038124 or vehiclePF-07038124 safe concentration or vehicle BID applied to 10% BSA	Drug	Part B Cohort 6 (10% Body Surface Area)

Primary outcome

Part A: Number of Participants with Treatment Emergent Treatment-Related Adverse Evenst (AEs)
Time frame: through study completion, up to 38 days
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Part A: Number of Adverse Events by Severity
Time frame: through study completion, up to 38 days
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: through study completion, up to 41 days
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
Part B: Number of Adverse Events by Severity
Time frame: through study completion, up to 41 days
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.

5 secondary outcomes

Part B: Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1 and 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1 and 10
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Days 1 and 10
Plasma Decay Half-Life (t1/2)
Time frame: Days 1 and 10
Average Concentration at Steady State (Cav)
Time frame: Day 10

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

Related trials for Dermatitis Atopic

RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Dermatitis Atopic, run by Pfizer 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 5 inclusion and 19 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 14 May 2020. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part A: Number of Participants with Treatment Emergent Treatment-Related Adverse Evenst (AEs) (time frame: through study completion, up to 38 days). The study lists 4 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 NCT04135560.

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 14 May 2020.