Healthy SubjectsPhase 1NCT03980080

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects

A Phase 1 study testing OSE-127 in people with Healthy Subjects, run by OSE Immunotherapeutics at 1 site in Belgium.

Completed

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

Trial summary

This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: OSE-127
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteBelgium
Study dates: 19 Dec 2018to 4 Nov 2019
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female, aged 18 to 65 years (extremes included). Maximum two subjects aged between 60 and 65 (extremes included) are allowed per dose group.
Healthy volunteers (medically stable), as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening and deemed appropriate by the Investigator.
Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the Investigator.
Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 19.0 ≤ BMI ≤ 30.0 kg/m².
Negative urine test for selected drugs of abuse at screening.
Negative alcohol breath test at screening.

Show all 12Show fewer

Female subjects is postmenopausal, surgically sterile (having had a hysterectomy or bilateral oophorectomy) and/or is using a highly effective method of contraception (from 2 weeks before first study drug administration until 28 days after the last follow-up visit, when it is confirmed that the RO of the subject <20% or 5 t1/2 whichever is longer).
Female subject has a negative pregnancy test at screening.
Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of a highly effective method of contraception (from the first study drug administration until 28 days after the last follow-up visit, when it is confirmed that the RO of the subject <20% or 5 t1/2 whichever is longer).
Willing to adhere to the prohibitions and restrictions specified in the protocol.
Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
Non-smoker or light smoker, i.e. smokes maximal 5 cigarettes (or 3 cigars or 3 pipe-full) per day, and ability and willingness to refrain from smoking during confinement and ambulant visits in the CPU.

Who cannot join

A history of any clinically significant (as determined by the Investigator) cardiac, endocrinology, hematology, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer.
A known allergy, hypersensitivity, or intolerance to any of the excipients in the formulation of the study drug.
The subject has a history of severe allergic or anaphylactic reactions.
The suject has a history of consuming more than 14 units of alcoholic beverages per week for male subjects, and more than 10 units for females. Or a history of alcoholism, or drug/chemical/substance abuse within the past 2 years prior to screening.
Evidence or history of any clinically significant infections within the past 3 months.
Subject with known clinically relevant immunological disorders, or auto-immune disorders (e.g. rheumatoid arthritis, lupus erythematosus, scleroderma, etc...).

Show all 18Show fewer

A positive hepatitis panel (including hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV] antibodies [Abs]) or positive human immunodeficiency virus (HIV) antibody screens.
The subject has a supine systolic blood pressure (SBP) <90 or >149 mmHg and/or a diastolic blood pressure (DBP) <45 or >90 mmHg, and/or a pulse rate higher than 100 beats per minute (bpm) at screening (blood pressure measurements taken after subject has been resting in a supine position for a minimum of 5 minutes).
Pregnant or breastfeeding women.
The subject has received a live vaccine (excluding flu vaccination), within 30 days prior to study drug administration, or plan to receive this type of vaccine during the study.
The subject has received any systemic immunosuppressant agent, within 6 months prior to study drug administration.
The subject has received any antibody or biologic medicinal product, within 6 months prior to study drug administration.
The subject has received any systemic steroid, within 2 months prior to study drug administration.
Use of a prohibited therapy during the study.
Receipt of any investigational drug, within 30 days or 5 half-lives (whichever is longer) prior to the initial study drug administration.
The subject is participating in another clinical trial or has participated in another dose group of the current trial. Participation in non-interventional registries or epidemiological studies is allowed.
Having had a significant blood loss (including blood donation [>500 mL]) or a having had a transfusion of any blood product (within the past 60 days) or donated plasma (within 7 days prior to the initial study drug administration).
A condition that, in the opinion of the Investigator, could compromise their well-being or the course of the study, or prevent them from meeting or performing any study requirement.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Life Sciences (SGS LS), Clinical Pharmacology Unit (CPU)
Antwerp, 2060

Other trials in Belgium

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects

Conditions: Healthy Subjects
Being tested: OSE-127, Placebo
Keywords: CD127/IL-7Rα Antagonist, Auto-Immune Diseases, inflammatory bowel diseases, Ulcerative Colitis
Medical subject headings: Inflammatory Bowel Diseases, Colitis, Ulcerative

What participants receive

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

OSE-127Drug
mAb antagonist to CD127 receptor (or IL-7Rα)
Group 1-7
6 escalating dose level groups IV
SC
PlaceboDrug
Vehicle study drug
OSE-127Drug
mAb antagonist to CD127 receptor (or IL-7Rα)
Group 8-9
2 escalating dose level groups IV

Study groups in NCT03980080
Study group	Role	What they receive
OSE-127: Part 1 (SAD), Cohort A & Cohort B	Experimental	Not described Receives: Drug: OSE-127
Placebo: Part 1 (SAD), Cohort A & Cohort B	Placebo comparator	Not described Receives: Drug: Placebo
OSE-127: Part 2 (MAD)	Experimental	Not described Receives: Drug: OSE-127
Placebo: Part 2 (MAD)	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in vital signs Reported as Adverse Event
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Findings in Telemetry Reported as Adverse Event
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)

Secondary outcomes (12)

Part 1 (SAD) & Part 2 (MAD) : Maximum Plasma Concentration [Cmax]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Average serum Concentration over the dosing interval [Cavg]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Trough serum Concentration observed at the end of the dosing interval [Ctrough]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Elimination half-life associated with the terminal rate constant (λz) [T1/2]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Time corresponding to the Cmax [Tmax]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Area Under the serum concentration-time Curve from time zero till X days postdose [AUCτ]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : AUC calculated between time of administration and last quantifiable concentration [AUClast]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : AUC extrapolated to infinity [AUCinf]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : AUC over the dosing interval [AUC0-τ].
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Accumulation Ratio [Rac].
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : CD-127 Receptor Occupancy [RO]
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Effect on total lymphocyte count
Measured: 12 weeks (for Part 1); 19 weeks (for Part 2)

Timeline

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

19 Dec 20184 Nov 2019

First posted10 Jun 2019
Study start19 Dec 2018
Primary completion4 Nov 2019
Study completion4 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
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: Parallel groups
Model description: Part 1 (SAD) primary objective : safety and tolerability profile of single ascending IV (Cohort A) and SC (Cohort B) doses given to healthy subjects, compared to placebo. Part 2 (MAD) primary objective : safety and tolerability profile of two IV doses given on two separate occasions to healthy subjects, compared to placebo.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03980080
Sponsor's protocol ID: OSE-127-C101
Other IDs: 2018-001832-22, 2018
Status last verified: Dec 2019
First submitted: 13 May 2019
Last updated: 12 Dec 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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

Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia

All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects
ClinicalTrials.gov ID: NCT03980080
Acronym / sponsor ID: OSE-127-C101
Conditions: Healthy Subjects
Keywords: CD127/IL-7Rα Antagonist, Auto-Immune Diseases, inflammatory bowel diseases, Ulcerative Colitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: OSE ImmunotherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Servier
Study start: 19 Dec 2018 (actual)
Primary completion: 4 Nov 2019 (actual)
Study completion: 4 Nov 2019 (actual)
First posted: 10 Jun 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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Part 1 (SAD) primary objective : safety and tolerability profile of single ascending IV (Cohort A) and SC (Cohort B) doses given to healthy subjects, compared to placebo. Part 2 (MAD) primary objective : safety and tolerability profile of two IV doses given on two separate occasions to healthy subjects, compared to placebo.

Arm	Type	Receives
OSE-127: Part 1 (SAD), Cohort A & Cohort B	Experimental	Drug: OSE-127
Placebo: Part 1 (SAD), Cohort A & Cohort B	Placebo comparator	Drug: Placebo
OSE-127: Part 2 (MAD)	Experimental	Drug: OSE-127
Placebo: Part 2 (MAD)	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male or female, aged 18 to 65 years (extremes included). Maximum two subjects aged between 60 and 65 (extremes included) are allowed per dose group.
Healthy volunteers (medically stable), as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening and deemed appropriate by the Investigator.
Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the Investigator.
Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 19.0 ≤ BMI ≤ 30.0 kg/m².
Negative urine test for selected drugs of abuse at screening.

Key exclusion criteria (18 listed)

A history of any clinically significant (as determined by the Investigator) cardiac, endocrinology, hematology, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer.
A known allergy, hypersensitivity, or intolerance to any of the excipients in the formulation of the study drug.
The subject has a history of severe allergic or anaphylactic reactions.
The suject has a history of consuming more than 14 units of alcoholic beverages per week for male subjects, and more than 10 units for females. Or a history of alcoholism, or drug/chemical/substance abuse within the past 2 years prior to screening.
Evidence or history of any clinically significant infections within the past 3 months.

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
OSE-127mAb antagonist to CD127 receptor (or IL-7Rα) Group 1-7 6 escalating dose level groups IV SC	Drug	OSE-127: Part 1 (SAD), Cohort A & Cohort B
PlaceboVehicle study drug	Drug	Placebo: Part 1 (SAD), Cohort A & Cohort B, Placebo: Part 2 (MAD)
OSE-127mAb antagonist to CD127 receptor (or IL-7Rα) Group 8-9 2 escalating dose level groups IV	Drug	OSE-127: Part 2 (MAD)

Primary outcome

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in vital signs Reported as Adverse Event
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Findings in Telemetry Reported as Adverse Event
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)

12 secondary outcomes

Part 1 (SAD) & Part 2 (MAD) : Maximum Plasma Concentration [Cmax]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Average serum Concentration over the dosing interval [Cavg]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Trough serum Concentration observed at the end of the dosing interval [Ctrough]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Elimination half-life associated with the terminal rate constant (λz) [T1/2]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Time corresponding to the Cmax [Tmax]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Area Under the serum concentration-time Curve from time zero till X days postdose [AUCτ]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : AUC calculated between time of administration and last quantifiable concentration [AUClast]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : AUC extrapolated to infinity [AUCinf]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : AUC over the dosing interval [AUC0-τ].
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Accumulation Ratio [Rac].
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : CD-127 Receptor Occupancy [RO]
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Effect on total lymphocyte count
Time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)

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 12 Dec 2019.
Individual participant dataSharing planned: Undecided

Related trials for Healthy Subjects

Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia

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.

Frédérique Corallo, MD study director

OSE Immunotherapeutics

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 testing OSE-127 in people with Healthy Subjects, run by OSE Immunotherapeutics at 1 site in Belgium.

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 12 inclusion and 18 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 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 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: 12 weeks (for Part 1); 19 weeks (for Part 2)). The study lists 7 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 NCT03980080.

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 12 Dec 2019.