Systemic Lupus ErythematosusPhase 1NCT05247203
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing Telitacicept and standard therapy in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 19 sites in China.
Trial summary
This is a multi-center, open-label, phase I study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Telitacicept and standard therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 19 sitesChina
- Study dates
- 11 May 2022to 13 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who give consent to this study participation and sign informed consent form;
- Males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit;
- Diagnosis of SLE as defined by the American College of Rheumatology (ACR) 1997 criteria, with 4 or more of the 11 ACR criteria present;
- SELENA-SLEDAI score ≥8 points with a clinical SELENA-SLEDAI score ≥6 points if low complement levels and/or anti-ds-DNA antibodies are present at the screening visit;
- Subjects with unequivocally positive test for anti-nuclear antibody (ANA) and/or anti-ds-DNA serum antibody;
- Be on a SLE standard treatment regimen (and remain stable) for a period of at least 30 days prior to Day 0. The standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.
Who cannot join
- Subjects with severe lupus kidney disease (defined by proteinuria >6g/24h or serum creatinine >2.5mg/dL or serum creatinine >221μmol/L) or active nephritis requiring prohibited medications, or subjects requiring hemodialysis or prednisone (or its equivalent)≥100mg/d for a period of ≥14 days within 8 weeks of Day 0;
- Central nervous system (CNS) disease associated with lupus or not [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), encephalitis, CNS angiitis] within 8 weeks prior to the screening visit;
- Laboratory abnormalities including, but not limited to the following:
- ALT/AST≥2×upper limit of normal (ULN);
- endogenous creatinine clearance rate<30 mL/min;
- white blood cell count<2.5×10^9/L;
Show all 21Show fewer
- hemoglobin<85 g/L;
- platelet count<50×10^9/L;
- Active hepatitis or a history of severe liver disease at the screening visit. Positive test for Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb). If anti-HBcAb result is positive while HBsAg result is negative, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA result is negative, the patient is eligible;
- Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;
- Pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study;
- History of allergy to humanized biological products;
- Subjects who received live vaccine within 28 days of Day 0;
- Participation in any other investigational study drug trial in the past 28 days or 5 half-lives, whichever was longer, prior to Day 0. Subjects who participated in a clinical trial on B-cell-targeted drug, or tumor necrosis factor inhibitor, or interleukin receptor blocker within 12 months prior to Day 0 would be excluded;
- Subjects who received other B-cell targeted drugs, such as Belimumab, rituximab or Epratuzumab within 12 months prior to Day 0;
- Subjects who received tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to Day 0;
- Subjects who received intravenous immune globulin (IVIG), or high dose prednisone or its equivalents (≥100mg/d) for a period of ≥ 14 days, or plasma exchange within 28 days prior to Day 0;
- Subjects who received IL-2, Thalidomide, Tripterygium wilfordii or Chinese medicinal preparations containing Tripterygium wilfordii within 28 days prior to Day 0;
- Subjects with active infections (herpes zoster, HIV infection, active tuberculosis, etc.) at the screening visit;
- Subjects with depression or suicidal thoughts;
- Any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol..
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650011
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052
The People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yantai Yuhuangding Hospital
Yantai, Shandong, 264200
About this study
Official title: A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)
This is a multi-center, open-label, phase I study.
Read the detailed description
The purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of Telitacicept in Chinese patients with systemic lupus erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Telitacicept, standard therapy
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, Pharmacokinetics, Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases
- Medical subject headings
- Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptBiological
Also called RC18
subcutaneous injection
standard therapyDrug
A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept Arm 1 | Experimental | Telitacicept 80mg, once a week for 24 weeks plus standard therapy Receives: Biological: Telitacicept; Drug: standard therapy |
| Telitacicept Arm 2 | Experimental | Telitacicept 160mg, once a week for 24 weeks plus standard therapy Receives: Biological: Telitacicept; Drug: standard therapy |
| Telitacicept Arm 3 | Experimental | Telitacicept 160mg, once a week for 12 weeks followed by once every two weeks for another 12 weeks plus standard therapy Receives: Biological: Telitacicept; Drug: standard therapy |
| Telitacicept Arm 4 | Experimental | Telitacicept 240mg, once a week for 24 weeks plus standard therapy Receives: Biological: Telitacicept; Drug: standard therapy |
| Telitacicept Arm 5 | Experimental | Telitacicept 240mg, once every two weeks for 24 weeks plus standard therapy Receives: Biological: Telitacicept; Drug: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of Telitacicept
Cmax is defined as peak plasma concentration of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Time to reach Cmax (tmax) of Telitacicept
tmax is defined as time to reach Cmax of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval (Ctrough)
Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval
Measured: up to 42 days following the last dose of Telitacicept
Average concentration (Cav) of Telitacicept
Average concentration of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Area under the curve from time zero to last quantifiable concentration (AUC 0-t) of Telitacicept
AUC 0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Area under the curve from time zero to tau (AUC 0-tau) of Telitacicept
AUC 0-tau is defined as area under the curve from time zero to tau of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Terminal elimination rate constant (λz) of Telitacicept
λz is defined as terminal elimination rate constant
Measured: up to 42 days following the last dose of Telitacicept
Terminal elimination half-life (t1/2z) of Telitacicept
t1/2z is defined as terminal elimination half-life of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Telitacicept
Vz/F is defined as apparent volume of distribution during the terminal phase after extravascular administration of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Telitacicept
CL/F is defined as apparent total body clearance of drug from plasma after extravascular administration of Telitacicept
Measured: up to 42 days following the last dose of Telitacicept
Secondary outcomes (9)
Percentage of participants achieving a SLE Responder Index (SRI)
Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA-SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
Measured: Week 4, 8, 12, 16, 20, and 24
Percentage of participants achieving a SELENA-SLEDAI improvement of ≥4 points
SELENA-SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105.
Measured: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in patient global assessment (PGA)
PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
Measured: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in IgG
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Measured: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in IgA
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Measured: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in IgM
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Measured: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in C3
Complement (C3/C4) are proteins that are part of the immune system.
Measured: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in C4
Complement (C3/C4) are proteins that are part of the immune system.
Measured: Week 4, 8, 12, 16, 20, and 24
Number of Participants Experiencing Adverse Events (AEs)
Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Measured: up to 28 days following the last dose of Telitacicept
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start11 May 2022
- Primary completion25 Oct 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247203
- Sponsor's protocol ID
- 18C020
- Status last verified
- Dec 2023
- First submitted
- 26 Jan 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT05247203
- Acronym / sponsor ID
- 18C020
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, Pharmacokinetics, Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 18 Feb 2022 (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.
This is a multi-center, open-label, phase I study.
Detailed description
The purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of Telitacicept in Chinese patients with systemic lupus erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Telitacicept Arm 1 | Experimental | Biological: Telitacicept, Drug: standard therapyTelitacicept 80mg, once a week for 24 weeks plus standard therapy |
| Telitacicept Arm 2 | Experimental | Biological: Telitacicept, Drug: standard therapyTelitacicept 160mg, once a week for 24 weeks plus standard therapy |
| Telitacicept Arm 3 | Experimental | Biological: Telitacicept, Drug: standard therapyTelitacicept 160mg, once a week for 12 weeks followed by once every two weeks for another 12 weeks plus standard therapy |
| Telitacicept Arm 4 | Experimental | Biological: Telitacicept, Drug: standard therapyTelitacicept 240mg, once a week for 24 weeks plus standard therapy |
| Telitacicept Arm 5 | Experimental | Biological: Telitacicept, Drug: standard therapyTelitacicept 240mg, once every two weeks for 24 weeks plus standard therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who give consent to this study participation and sign informed consent form;
- Males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit;
- Diagnosis of SLE as defined by the American College of Rheumatology (ACR) 1997 criteria, with 4 or more of the 11 ACR criteria present;
- SELENA-SLEDAI score ≥8 points with a clinical SELENA-SLEDAI score ≥6 points if low complement levels and/or anti-ds-DNA antibodies are present at the screening visit;
- Subjects with unequivocally positive test for anti-nuclear antibody (ANA) and/or anti-ds-DNA serum antibody;
Key exclusion criteria (21 listed)
- Subjects with severe lupus kidney disease (defined by proteinuria >6g/24h or serum creatinine >2.5mg/dL or serum creatinine >221μmol/L) or active nephritis requiring prohibited medications, or subjects requiring hemodialysis or prednisone (or its equivalent)≥100mg/d for a period of ≥14 days within 8 weeks of Day 0;
- Central nervous system (CNS) disease associated with lupus or not [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), encephalitis, CNS angiitis] within 8 weeks prior to the screening visit;
- Laboratory abnormalities including, but not limited to the following:
- Active hepatitis or a history of severe liver disease at the screening visit. Positive test for Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb). If anti-HBcAb result is positive while HBsAg result is negative, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA result is negative, the patient is eligible;
- Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;
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 |
|---|---|---|
| TelitaciceptAlso: RC18subcutaneous injection | Biological | Telitacicept Arm 1, Telitacicept Arm 2, Telitacicept Arm 3, Telitacicept Arm 4, Telitacicept Arm 5 |
| standard therapyA standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine. | Drug | Telitacicept Arm 1, Telitacicept Arm 2, Telitacicept Arm 3, Telitacicept Arm 4, Telitacicept Arm 5 |
Primary outcome
Peak plasma concentration (Cmax) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
Cmax is defined as peak plasma concentration of Telitacicept
Time to reach Cmax (tmax) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
tmax is defined as time to reach Cmax of Telitacicept
Observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval (Ctrough)
Time frame: up to 42 days following the last dose of Telitacicept
Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval
Average concentration (Cav) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
Average concentration of Telitacicept
Area under the curve from time zero to last quantifiable concentration (AUC 0-t) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
AUC 0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept
Area under the curve from time zero to tau (AUC 0-tau) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
AUC 0-tau is defined as area under the curve from time zero to tau of Telitacicept
Terminal elimination rate constant (λz) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
λz is defined as terminal elimination rate constant
Terminal elimination half-life (t1/2z) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
t1/2z is defined as terminal elimination half-life of Telitacicept
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
Vz/F is defined as apparent volume of distribution during the terminal phase after extravascular administration of Telitacicept
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
CL/F is defined as apparent total body clearance of drug from plasma after extravascular administration of Telitacicept
9 secondary outcomes
Percentage of participants achieving a SLE Responder Index (SRI)
Time frame: Week 4, 8, 12, 16, 20, and 24
Percentage of participants achieving a SELENA-SLEDAI improvement of ≥4 points
Time frame: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in patient global assessment (PGA)
Time frame: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in IgG
Time frame: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in IgA
Time frame: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in IgM
Time frame: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in C3
Time frame: Week 4, 8, 12, 16, 20, and 24
Change From Baseline to W24 in C4
Time frame: Week 4, 8, 12, 16, 20, and 24
Number of Participants Experiencing Adverse Events (AEs)
Time frame: up to 28 days following the last dose of Telitacicept
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 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telitacicept and standard therapy in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 19 sites in China.
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 6 inclusion and 21 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. 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?
Peak plasma concentration (Cmax) of Telitacicept (time frame: up to 42 days following the last dose of Telitacicept). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2023.