Multiple SclerosisPhase 3NCT04966338
Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis
A Phase 3 study testing Ocrelizumab (CinnaGen, Iran) and Ocrelizumab (Roche, Switzerland) in people with Multiple Sclerosis and Relapsing-Remitting, run by Cinnagen at 15 sites in Iran.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Ocrelizumab (CinnaGen, Iran) and Ocrelizumab (Roche, Switzerland)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 15 sitesIran
- Study dates
- 19 Aug 2019to 1 Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
- Ages 18-55 years at screening, inclusive.
- Diagnosis of MS, in accordance with the revised McDonald criteria (2010).
- At least two relapses having occurred within the past 2 years or one relapse within the past 12 months prior to screening.
- Neurological stability for ≥ 30 days prior to both screening and baseline.
- EDSS, at screening, from 0 to 5.5 inclusive.
- Patients of reproductive potential must use reliable means of contraception.
Who cannot join
- Diagnosis of primary progressive MS.
- Disease duration of more than 10 years in patients with an EDSS ≤ 2.0 at screening.
- Inability to complete an MRI (contraindications for MRI include but are not restricted to claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).
- Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
- Pregnancy or lactation.
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
Show all 35Show fewer
- History or currently active primary or secondary immunodeficiency.
- Lack of peripheral venous access.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study such as Congestive heart failure (NYHA III or IV functional severity).
- Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds.
- Infection requiring hospitalization or treatment with I.V. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit.
- History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV).
- History of progressive multifocal leukoencephalopathy (PML)
- History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins.
- History of alcohol or drug abuse within 24 weeks prior to baseline.
- History or laboratory evidence of coagulation disorders.
- Receipt of a live vaccine (BCG, MMR, VZV, polio, yellow fever and some influenza vaccine) within 6 weeks prior to baseline. In rare cases when patient requires vaccination with a live vaccine, the screening period may be extended but cannot exceed 8 weeks.
- Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer).
- Contraindications to or intolerance of oral or i.v. corticosteroids, including methylprednisolone administered i.v.
- Treatment with dalfampridine unless on stable dose for ≥ 30 days prior to screening. Patients should remain on stable doses throughout the 48 weeks' treatment period.
- Previous treatment with B-cell targeted therapies (i.e. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab).
- Systemic corticosteroid therapy within 4 weeks prior to screening.
- Any previous treatment with anti-CD4, cladribine, mitoxantrone, daclizumab, teriflunomide, laquinimod, total body irradiation or bone marrow transplantation.
- Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), cyclosporine, methotrexate or natalizumab within 24 months prior to screening. Patients previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was < 1 year.
- Treatment with fingolimod or dimethyl fumarate (DMF) within 4 weeks prior to screening. Only patients with T lymphocyte count ≥ LLN will be eligible for this study.
- Treatment with I.V. immunoglobulin within 12 weeks prior to baseline.
- Positive serum β hCG measured at screening.
- Positive screening tests for hepatitis B
- CD4 count < 300/μL.
- AST/SGOT or ALT/SGPT ≥ 2.0 Upper Limit of Normal (ULN).
- Platelet count <100,000/μL (<100 x 109/L).
- Levels of serum IgG 18% below the LLN.
- Levels of serum IgM 8% below the LLN.
- Total neutrophil count <1.5 x 10^3/μL.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Iran15 sites
Golestan Hospital
Ahvāz, Khozestan
Sina Hospital
Hamadan
Ayatollah Kashani Hospital, MS Clinic
Isfahan
Shafa Hospital
Kerman
Imam Reza Hospital
Kermanshah
Qaem Hospital
Mashhad, Razavi Khorasan Province
Qaem International Hospital
Rasht, Gilan Province
Bouali Hospital, MS Clinic
Sari, Mazandaran
Dr. Nikseresht's office
Shiraz
Namazi Hospital
Shiraz
Imam Reza Hospital Department of Neurology
Tabriz
Amir Alam Hospital
Tehran
Imam Hossein Hospital, MS Clinic
Tehran
Imam Khomeini Hospital
Tehran
Sina Hospital, MS Research Center
Tehran
About this study
Official title: A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple Sclerosis
The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS).
All the participants will receive one of the following regimens:
Read more
Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks.
The primary objective of this study is to verify the equivalency of Ocrelizumab (CinnaGen) versus Ocrevus® (Roche, Switzerland) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Ocrelizumab (CinnaGen, Iran), Ocrelizumab (Roche, Switzerland)
- Keywords
- RRMS, Annualized Relapse Rate, Monoclonal, Humanized, Ocrelizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocrelizumab (CinnaGen, Iran)Biological
Also called Xacrel®
Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.
Ocrelizumab (Roche, Switzerland)Biological
Also called Ocrevus®
Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab (CinnaGen, Iran) | Experimental | Ocrelizumab (CinnaGen, Iran) 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks. Receives: Biological: Ocrelizumab (CinnaGen, Iran) |
| Ocrelizumab (Roche, Switzerland) | Active comparator | Ocrelizumab (Roche, Switzerland) 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks. Receives: Biological: Ocrelizumab (Roche, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate at 48 weeks
Total number of confirmed relapses divided by the total number of days on study A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection
Measured: 48 weeks
Secondary outcomes (9)
Time to onset of sustained disability progression for at least 12 weeks
Disability progression is defined as an increase in the Expanded Disability Status Scale (EDSS) score of:
- At least a 1.5-point increase in patients with a baseline score of 0 B) At least a 1.0-point increase on the EDSS in patients with a baseline score of 0<EDSS≤5.5 C) At least a 0.5-point increase on the EDSS in patients with a baseline score of >5.5
The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis)
Measured: Baseline up to Week 96
Time to onset of sustained disability progression for at least 24 weeks
Disability progression is defined as an increase in the Expanded Disability Status Scale (EDSS) score of:
- At least a 1.5-point increase in patients with a baseline score of 0 B) At least a 1.0-point increase on the EDSS in patients with a baseline score of 0<EDSS≤5.5 C) At least a 0.5-point increase on the EDSS in patients with a baseline score of >5.5
The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis)
Measured: Baseline up to Week 96
Proportion of relapse-free patients by 96 weeks
A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection
Measured: Week 96
Total number of new Gadolinium (Gd)-enhancing lesions as detected by brain MRI
Sum of the individual number of (Gd)-enhancing lesions at Weeks 24, 48, and 96
Measured: Baseline up to Week 96
Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI
Sum of the individual number of new, and/or enlarging T2 hyperintense lesions at Weeks 24, 48, and 96
Measured: Baseline up to Week 96
Change in total T2 lesion volume as detected by brain MRI from baseline to week 96
Measured: Baseline up to Week 96
Number of Participants With Adverse Events (AEs)
Intensity, seriousness and causality assessment of observed AEs, and abnormal laboratory findings every 12 weeks.
Measured: Baseline up to Week 96
Number of Participants With Infusion Related Reactions (IRRs)
Assessment of IRRs every 24 weeks
Measured: Baseline up to Week 96
Immunogenicity Assessment
Number of participants positive for anti-drug antibodies at weeks 24, 48 and 96
Measured: Baseline up to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start19 Aug 2019
- Primary completion9 Nov 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammad Ali Sahraian, professor, Principal investigator, Neurologist/MS Research Center, Neuroscience Institute ,Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966338
- Sponsor's protocol ID
- OCR.CIN.MS.96.III
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahraian MA, Abolfazli R, Shaygannejad V, Ashtari F, Majdinasab N, Navardi S, Baghbanian SM, Sedighi B, Naser Moghadasi A, Nahayati MA, Ghalyanchi Langroodi H, Mohammadianinejad SE, Beladi Moghadam N, Ayromlou H, Nikseresht A, Ghiasian M, Razazian N, Asadollahzadeh E, Sabzvari A, Kafi H, Albooyeh S. Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. Sci Rep. 2024 Oct 22;14(1):24921. doi: 10.1038/s41598-024-75745-y.
PubMed 39438591
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04966338
- Acronym / sponsor ID
- OCR.CIN.MS.96.III
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- RRMS, Annualized Relapse Rate, Monoclonal, Humanized, Ocrelizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 19 Jul 2021 (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.
The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS).
All the participants will receive one of the following regimens:
Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks.
The primary objective of this study is to verify the equivalency of Ocrelizumab (CinnaGen) versus Ocrevus® (Roche, Switzerland) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab (CinnaGen, Iran) | Experimental | Biological: Ocrelizumab (CinnaGen, Iran)Ocrelizumab (CinnaGen, Iran) 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks. |
| Ocrelizumab (Roche, Switzerland) | Active comparator | Biological: Ocrelizumab (Roche, Switzerland)Ocrelizumab (Roche, Switzerland) 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
- Ages 18-55 years at screening, inclusive.
- Diagnosis of MS, in accordance with the revised McDonald criteria (2010).
- At least two relapses having occurred within the past 2 years or one relapse within the past 12 months prior to screening.
- Neurological stability for ≥ 30 days prior to both screening and baseline.
Key exclusion criteria (35 listed)
- Diagnosis of primary progressive MS.
- Disease duration of more than 10 years in patients with an EDSS ≤ 2.0 at screening.
- Inability to complete an MRI (contraindications for MRI include but are not restricted to claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).
- Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
- Pregnancy or lactation.
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 |
|---|---|---|
| Ocrelizumab (CinnaGen, Iran)Also: Xacrel®Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion. | Biological | Ocrelizumab (CinnaGen, Iran) |
| Ocrelizumab (Roche, Switzerland)Also: Ocrevus®Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion. | Biological | Ocrelizumab (Roche, Switzerland) |
Primary outcome
Annualized Relapse Rate at 48 weeks
Time frame: 48 weeks
Total number of confirmed relapses divided by the total number of days on study A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection
9 secondary outcomes
Time to onset of sustained disability progression for at least 12 weeks
Time frame: Baseline up to Week 96
Time to onset of sustained disability progression for at least 24 weeks
Time frame: Baseline up to Week 96
Proportion of relapse-free patients by 96 weeks
Time frame: Week 96
Total number of new Gadolinium (Gd)-enhancing lesions as detected by brain MRI
Time frame: Baseline up to Week 96
Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI
Time frame: Baseline up to Week 96
Change in total T2 lesion volume as detected by brain MRI from baseline to week 96
Time frame: Baseline up to Week 96
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 96
Number of Participants With Infusion Related Reactions (IRRs)
Time frame: Baseline up to Week 96
Immunogenicity Assessment
Time frame: Baseline up to Week 96
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 18 Oct 2022.
- Derived from this study: PubMed 39438591Sahraian MA, Abolfazli R, Shaygannejad V, Ashtari F, Majdinasab N, Navardi S, Baghbanian SM, Sedighi B, Naser Moghadasi A, Nahayati MA, Ghalyanchi Langroodi H, Mohammadianinejad SE, Beladi Moghadam N, Ayromlou H, Nikseresht A, Ghiasian M, Razazian N, Asadollahzadeh E, Sabzvari A, Kafi H, Albooyeh S. Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. Sci Rep. 2024 Oct 22;14(1):24921. doi: 10.1038/s41598-024-75745-y.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Mohammad Ali Sahraian, professor principal investigator
Neurologist/MS Research Center, Neuroscience Institute ,Tehran University of Medical Sciences
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ocrelizumab (CinnaGen, Iran) and Ocrelizumab (Roche, Switzerland) in people with Multiple Sclerosis and Relapsing-Remitting, run by Cinnagen at 15 sites in Iran.
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 7 inclusion and 35 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Annualized Relapse Rate at 48 weeks (time frame: 48 weeks). 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 NCT04966338, 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 18 Oct 2022.