Relapsing Multiple Sclerosis (RMS)Phase 4NCT04878211

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

A Phase 4 study testing Ofatumumab, mRNA COVID-19 vaccine and interferon or glatiramer acetate in people with Relapsing Multiple Sclerosis (RMS), run by Novartis Pharmaceuticals at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing Multiple Sclerosis (RMS)
What is being tested?: Ofatumumab, mRNA COVID-19 vaccine and interferon or glatiramer acetate
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 7 sitesUnited States
Study dates: 10 Jun 2021to 14 Apr 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Signed informed consent must be obtained prior to participation in the study
Diagnosis of relapsing MS by 2017 revised McDonald criteria
Were willing to comply with the study schedule
Cohort 1: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
Cohort 2: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
Cohort 3: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on interferon or glatiramer acetate for at least 4 weeks

Show all 9Show fewer

Cohort 4: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
Cohort 5: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine), with or without a booster, and on interferon or glatiramer acetate for at least 4 weeks
Cohort 6: Fully vaccinated with a non-live COVID mRNA vaccine, (Pfizer or Moderna vaccine), with a booster, and on ofatumumab for at least 4 weeks

Who cannot join

Received the J\&J vaccine.
Had a contraindication to receiving an mRNA COVID-19 vaccine
Had an immediate allergic reaction to past vaccine or injection
Experienced a major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
The Neurological Institute PA
Charlotte, North Carolina, 28204
Infinity Clinical Research LLC .
Hollywood, Florida, 33024
Center For Neurology and Spine
Phoenix, Arizona, 85032
Minnesota Center Multiple Sclerosis
Plymouth, Minnesota, 55446
The MS Center for Innovation in Care
St Louis, Missouri, 63131
Dragonfly Research LLC
Wellesley, Massachusetts, 02481

Other trials in United States

About this study

Official title: An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

Read the detailed description

This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants. The study was intended to address two questions: 1) Can participants treated with ofatumumab develop an immune response if receiving a COVID-19 mRNA vaccine two weeks prior to ofatumumab start? 2) If receiving COVID-19 mRNA vaccine after introduction of ofatumumab treatment, can participants develop an immune response? Cohort 1: participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. Cohort 2: participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. Cohort 3: participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine. Cohort 4: participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. Cohort 5: participants vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and on interferon or glatiramer acetate. Cohort 6: participants fully vaccinated with an RNA COVID-19 vaccine who received a booster dose at least four weeks after ofatumumab start. Participants obtained the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg s.c. administered monthly. All other cohorts continued current dosing schedule of either ofatumumab, glatiramer acetate or interferon. Participation in trial was maximum of 421 days which was dependent on the Cohort.

Conditions: Relapsing Multiple Sclerosis (RMS)
Being tested: Ofatumumab, mRNA COVID-19 vaccine, interferon or glatiramer acetate
Keywords: Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157
Medical subject headings: Multiple Sclerosis, COVID-19, Coronavirus Infections

What participants receive

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

OfatumumabDrug
3 loading doses followed by monthly administrations
mRNA COVID-19 vaccineBiological
Pfizer or Moderna mRNA Vaccine
interferon or glatiramer acetateDrug
iDMT

Study groups in NCT04878211
Study group	Role	What they receive
Cohort 1 - 2 WKs vaccine prior to OMB157	Experimental	Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous). Receives: Drug: Ofatumumab; Biological: mRNA COVID-19 vaccine
Cohort 2 - vaccine 4 WKs after OMB157	Experimental	Participants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous). Receives: Drug: Ofatumumab; Biological: mRNA COVID-19 vaccine
Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after	Active comparator	Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate Receives: Biological: mRNA COVID-19 vaccine; Drug: interferon or glatiramer acetate
Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs	Experimental	Participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous) Receives: Drug: Ofatumumab; Biological: mRNA COVID-19 vaccine
Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster	Experimental	Participants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks. Receives: Biological: mRNA COVID-19 vaccine; Drug: interferon or glatiramer acetate
Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster	Experimental	Participants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous) Receives: Drug: Ofatumumab; Biological: mRNA COVID-19 vaccine

What is being measured

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

Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Measured: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1

Secondary outcomes (2)

Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Measured: Vaccination up to 70, 180, 270 and 360 days
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination.
Measured: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1

Timeline

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

10 Jun 202114 Apr 2023

First posted7 May 2021
Study start10 Jun 2021
Primary completion14 Apr 2023
Study completion14 Apr 2023

Why it stopped: Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.

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.
Other trials for Relapsing Multiple Sclerosis (RMS)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04878211
Sponsor's protocol ID: COMB157GUS16
Status last verified: May 2025
First submitted: 3 May 2021
Last updated: 16 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

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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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
ClinicalTrials.gov ID: NCT04878211
Acronym / sponsor ID: COMB157GUS16
Conditions: Relapsing Multiple Sclerosis (RMS)
Keywords: Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.
Enrolment: 24 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 10 Jun 2021 (actual)
Primary completion: 14 Apr 2023 (actual)
Study completion: 14 Apr 2023 (actual)
First posted: 7 May 2021 (actual)
Results: Posted 20 Jun 2024

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1 - 2 WKs vaccine prior to OMB157	Experimental	Drug: Ofatumumab, Biological: mRNA COVID-19 vaccineParticipants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).
Cohort 2 - vaccine 4 WKs after OMB157	Experimental	Drug: Ofatumumab, Biological: mRNA COVID-19 vaccineParticipants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous).
Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after	Active comparator	Biological: mRNA COVID-19 vaccine, Drug: interferon or glatiramer acetateParticipants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs	Experimental	Drug: Ofatumumab, Biological: mRNA COVID-19 vaccineParticipants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster	Experimental	Biological: mRNA COVID-19 vaccine, Drug: interferon or glatiramer acetateParticipants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks.
Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster	Experimental	Drug: Ofatumumab, Biological: mRNA COVID-19 vaccineParticipants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Signed informed consent must be obtained prior to participation in the study
Diagnosis of relapsing MS by 2017 revised McDonald criteria
Were willing to comply with the study schedule
Cohort 1: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
Cohort 2: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks

Key exclusion criteria (4 listed)

Received the J\&J vaccine.
Had a contraindication to receiving an mRNA COVID-19 vaccine
Had an immediate allergic reaction to past vaccine or injection
Experienced a major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit

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
Ofatumumab3 loading doses followed by monthly administrations	Drug	Cohort 1 - 2 WKs vaccine prior to OMB157, Cohort 2 - vaccine 4 WKs after OMB157, Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs, Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster
mRNA COVID-19 vaccinePfizer or Moderna mRNA Vaccine	Biological	Cohort 1 - 2 WKs vaccine prior to OMB157, Cohort 2 - vaccine 4 WKs after OMB157, Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after, Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs, Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster, Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster
interferon or glatiramer acetateiDMT	Drug	Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after, Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster

Primary outcome

Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).

2 secondary outcomes

Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Time frame: Vaccination up to 70, 180, 270 and 360 days
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1

Results and safety

Results posted to the registry on 20 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C1: VN - Plan to Start OMB157	5	4
C2: VN - on OMB157 >=4 WKs	2	2
C3: VN - INFy or GA >=4 WKs	0	0
C4: FV - OMB157 >=4 WKs	1	0
C5: FV - INFy or GA >=4 WKs	11	1
C6: FV - on OMB157 >=4 WKs + Booster	5	0

Primary outcome: Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)

Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	C1: VN - Plan to Start OMB157 n = 5	C2: VN - on OMB157 >=4 WKs n = 2	C3: VN - INFy or GA >=4 WKs n = 0	C4: FV - OMB157 >=4 WKs n = 1	C5: FV - INFy or GA >=4 WKs n = 11	C6: FV - on OMB157 >=4 WKs + Booster n = 5	Overall n = 24
Value	100.0 (47.8 to 100.0)	100.0 (15.8 to 100.0)	–	0.0 (0.0 to 97.5)	100.0 (69.2 to 100.0)	50.0 (6.8 to 93.2)	86.4 (65.1 to 97.1)

Population analysed: Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry. Overall number analyzed included participants who received full course of vaccine (2 doses. n =number of participants with a positive result (responders). M = number of participants in the safety analysis set who received full course (2 doses) of a COVID 19 vaccine, including a COVID-19 booster for Cohort 6 participants

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Cohort 2	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Cohort 3	0 of 0	0 of 0	0
Cohort 4	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Cohort 5	1 of 11 (9.1%)	2 of 11 (18.2%)	0 of 11
Cohort 6	1 of 5 (20%)	2 of 5 (40%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

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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.

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

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2024). 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?

Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) (time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1). 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 NCT04878211.

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 16 May 2025.