HealthyPhase 1NCT04390568

A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body

A Phase 1 study testing Spesolimap in people with Healthy, run by Boehringer Ingelheim at 1 site in China.

Completed

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

Trial summary

The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Spesolimap
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 21 May 2020to 4 Jun 2021
Phase: Phase 1
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects (at least three subjects for each gender within each dose group) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), 12-lead ECG, and clinical laboratory tests.
Chinese ethnicity, according to the following criteria: Ethnic Chinese, born in China and have 4 ethnic grandparents who were all born in China
Age of 18 to 45 years (inclusive)
Body weight ≥50 kg for male and ≥45 kg for female with body mass index (BMI) range ≥19 and < 26 kg/m2 at visit 1
Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation
Female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 16 weeks after trial completion [c03320877-06]:

Show all 10Show fewer

Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information
A vasectomised sexual partner (vasectomy at least one year prior to enrolment)
Surgically sterilised (including hysterectomy)
Postmenopausal, defined as at least one year of spontaneous amenorrhoea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 mg/L is confirmatory)

Who cannot join

Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to treatment or planned within 12 months after screening, e.g. hip replacement
Any finding in the medical examination (including BP, PR, RR, Body temperature or 12-lead ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections including active and latent tuberculosis, human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON tuberculosis (TB) test will be performed at screening Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Hospital, Fudan University
Shanghai, 200040

Other trials in China

About this study

Official title: An Open-label Phase I Trial to Assess Pharmacokinetics and Safety of Single Subcutaneous Doses and Single Intravenous Doses of BI 655130 in Healthy Chinese Male and Female Subjects (Single Doses, Open-label Study in Parallel-group Design).

The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.

Conditions: Healthy
Being tested: Spesolimap

What participants receive

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

SpesolimapDrug
Also called BI 655130
Spesolimap

Study groups in NCT04390568
Study group	Role	What they receive
Spesolimap (BI 655130) - 450 milligram (mg) - intravenous (IV)	Experimental	A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast. Receives: Drug: Spesolimap
Spesolimap - 900 mg - IV	Experimental	A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast. Receives: Drug: Spesolimap
Spesolimap - 1200 mg - IV	Experimental	A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast. Receives: Drug: Spesolimap
Spesolimap - 300 mg - subcutaneous (SC)	Experimental	A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast. Receives: Drug: Spesolimap
Spesolimap - 600 mg - SC	Experimental	A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast. Receives: Drug: Spesolimap

What is being measured

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

Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
Measured: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Maximum Measured Concentration of the Spesolimap in Plasma (Cmax)
Maximum measured concentration of the Spesolimap in plasma (Cmax) The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-8).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
Measured: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.

Secondary outcomes (2)

Number of Participants With Treatment-emergent Adverse Events (AE)s
Number of participants with treatment-emergent AEs.
All AEs occurring between first drug administration until 16 weeks thereafter were assigned to the randomised treatment.
Measured: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.
Number of Participants With Drug-related Adverse Events (AEs).
Number of participants with drug-related AEs.
All AEs occurring between first drug administration until 16 weeks thereafter were assigned to the randomised treatment.
Measured: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.

Timeline

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

21 May 20204 Jun 2021

First posted15 May 2020
Study start21 May 2020
Primary completion7 Apr 2021
Study completion4 Jun 2021

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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04390568
Sponsor's protocol ID: 1368-0043
Status last verified: Sep 2022
First submitted: 13 May 2020
Last updated: 7 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Publications

Cao G, Yang H, Wang J, Ishida M, Thoma C, Haeufel T, Bossert S, Zhang J. Pharmacokinetics and Safety of Spesolimab in Healthy Chinese Subjects: An Open-Label, Phase I Study. Adv Ther. 2024 Sep;41(9):3557-3568. doi: 10.1007/s12325-024-02940-8. Epub 2024 Jul 22.
PubMed 39039387

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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase I Trial to Assess Pharmacokinetics and Safety of Single Subcutaneous Doses and Single Intravenous Doses of BI 655130 in Healthy Chinese Male and Female Subjects (Single Doses, Open-label Study in Parallel-group Design).
ClinicalTrials.gov ID: NCT04390568
Acronym / sponsor ID: 1368-0043
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 May 2020 (actual)
Primary completion: 7 Apr 2021 (actual)
Study completion: 4 Jun 2021 (actual)
First posted: 15 May 2020 (actual)
Results: Posted 7 Aug 2023

Clinical summary

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

The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Spesolimap (BI 655130) - 450 milligram (mg) - intravenous (IV)	Experimental	Drug: SpesolimapA single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.
Spesolimap - 900 mg - IV	Experimental	Drug: SpesolimapA single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.
Spesolimap - 1200 mg - IV	Experimental	Drug: SpesolimapA single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.
Spesolimap - 300 mg - subcutaneous (SC)	Experimental	Drug: SpesolimapA single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.
Spesolimap - 600 mg - SC	Experimental	Drug: SpesolimapA single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy male or female subjects (at least three subjects for each gender within each dose group) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), 12-lead ECG, and clinical laboratory tests.
Chinese ethnicity, according to the following criteria: Ethnic Chinese, born in China and have 4 ethnic grandparents who were all born in China
Age of 18 to 45 years (inclusive)
Body weight ≥50 kg for male and ≥45 kg for female with body mass index (BMI) range ≥19 and < 26 kg/m2 at visit 1
Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation

Key exclusion criteria (8 listed)

Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to treatment or planned within 12 months after screening, e.g. hip replacement
Any finding in the medical examination (including BP, PR, RR, Body temperature or 12-lead ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator

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
SpesolimapAlso: BI 655130Spesolimap	Drug	Spesolimap (BI 655130) - 450 milligram (mg) - intravenous (IV), Spesolimap - 1200 mg - IV, Spesolimap - 300 mg - subcutaneous (SC), Spesolimap - 600 mg - SC, Spesolimap - 900 mg - IV

Primary outcome

Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
Maximum Measured Concentration of the Spesolimap in Plasma (Cmax)
Time frame: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Maximum measured concentration of the Spesolimap in plasma (Cmax) The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-8). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.

2 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (AE)s
Time frame: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.
Number of Participants With Drug-related Adverse Events (AEs).
Time frame: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.

Results and safety

Results posted to the registry on 7 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV)	10	10
Spesolimap - 900 mg - IV	10	10
Spesolimap - 1200 mg - IV	10	10
Spesolimap - 300 mg - Subcutaneous (SC)	10	10
Spesolimap - 600 mg - SC	10	10

Primary outcome: Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Time frame: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: Day times microgram per milliliter

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n = 10	Spesolimap - 900 mg - IV n = 9	Spesolimap - 1200 mg - IV n = 10	Spesolimap - 300 mg - Subcutaneous (SC) n = 10	Spesolimap - 600 mg - SC n = 10
Value	3380 (17.5)	6960 (19.2)	10300 (21.1)	1580 (22.2)	3260 (34.1)

Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) vs Spesolimap - 900 mg - IV vs Spesolimap - 1200 mg - IV: Slope: 1.123 (90% CI 0.979 to 1.268)

Population analysed: PK parameter analysis set (PKS): This set included all participants in the treated (TS) who provided at least one primary pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. PK data from replaced participants was expected to be not evaluable and thus replaced participants were not part of the PKS. One participant (900 mg IV group) missed the last measurement time point and was removed from the analyses.

Primary outcome: Maximum Measured Concentration of the Spesolimap in Plasma (Cmax)

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n = 10	Spesolimap - 900 mg - IV n = 10	Spesolimap - 1200 mg - IV n = 10	Spesolimap - 300 mg - Subcutaneous (SC) n = 10	Spesolimap - 600 mg - SC n = 10
Value	176 (12.5)	370 (15.1)	504 (17.3)	32.0 (16.8)	69.2 (35.7)

Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) vs Spesolimap - 900 mg - IV: Slope: 1.072 (90% CI 0.961 to 1.183)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV)	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Spesolimap - 900 mg - IV	1 of 10 (10%)	9 of 10 (90%)	0 of 10
Spesolimap - 1200 mg - IV	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Spesolimap - 300 mg - Subcutaneous (SC)	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Spesolimap - 600 mg - SC	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39039387Cao G, Yang H, Wang J, Ishida M, Thoma C, Haeufel T, Bossert S, Zhang J. Pharmacokinetics and Safety of Spesolimab in Healthy Chinese Subjects: An Open-Label, Phase I Study. Adv Ther. 2024 Sep;41(9):3557-3568. doi: 10.1007/s12325-024-02940-8. Epub 2024 Jul 22.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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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.

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 Spesolimap in people with Healthy, run by Boehringer Ingelheim at 1 site 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 10 inclusion and 8 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 7 Aug 2023. 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 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?

Yes. Results are posted in the registry (first posted 7 Aug 2023). 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?

Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (time frame: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.). The study lists 2 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 NCT04390568, 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 7 Aug 2023.