Generalized Myasthenia GravisPhase 3ADAPTscNCT04735432
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
A Phase 3 study testing efgartigimod PH20 SC and efgartigimod IV in people with Generalized Myasthenia Gravis, run by argenx at 47 sites in 11 countries.
Trial summary
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- efgartigimod PH20 SC and efgartigimod IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 47 sitesin 11 countries
- Study dates
- 5 Feb 2021to 13 Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bullet list of each inclusion criterium:
- Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- At least 18 years of age at the time of signing the informed consent form.
- Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by at least 1 of the following:
- History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation
- History of positive edrophonium chloride test
- Demonstrated improvement in Myasthenia Gravis (MG) signs upon treatment with oral acetylcholinesterase (AChE) inhibitors as assessed by the treating physician
- Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb
Who cannot join
- Bullet list of each exclusion criterium:
- Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of Investigational Medicinal Product.
- Has any of the following medical conditions:
- Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
- Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk.
- History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time:
Show all 11Show fewer
- adequately treated basal cell or squamous cell skin cancer
- carcinoma in situ of the cervix
- carcinoma in situ of the breast
- incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b).
- Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
Trial locations and contacts
47 sites in 11 countries.
47 sites in 11 countries
United States14 sites
Investigator Site 11 - US0010111
Amherst, New York, 14226
Investigator Site 47 - US0010113
Augusta, Georgia, 30912
Investigator Site 28 - US0010066
Austin, Texas, 78756
Investigator site 2 - US0010108
Boca Raton, Florida, 33428
Investigator site 2 - US0010032
Carlsbad, California, 92011
Investigator Site 40 - US0010003
Chapel Hill, North Carolina, 27514
Investigator Site 43 - 0010019
Cleveland, Ohio, 44195
Investigator site 4 - US0010008
Cordova, Tennessee, 38018
Investigator Site 38 - US0010077
Durham, North Carolina, 27710
Investigator Site 42 - US0010015
Kansas City, Kansas, 66205
Investigator Site 41 - US0010004
Orange, California, 92868
Investigator site 1 - US0010110
Port Charlotte, Florida, 33952
Investigator Site 27 - US0010006
Tampa, Florida, 41076
Investigator Site 46 - US0010009
Texas City, Texas, 78229
Japan8 sites
Investigator Site 18 - JP0810002
Chiba, 260-8677
Investigator site 6 - JPN0810004
Hanamaki, 025-0082
Investigator Site 33 - JP0810058
Hiroshima, 0810058
Investigator Site 19 - JP0810007
Osaka, 565-0871
Investigator Site 31 - JP0810055
Sapporo, Hokkaido, 063-0005
Investigator Site 34 - JP0810005
Sendai, 983-8520
Investigator Site 32 - JP0810059
Tokyo, 143-8541
Investigator Site 20 - JP0810009
Tokyo, 160-0023
Poland6 sites
Investigator Site 21 - PL0480001
Gdansk, 80-952
Investigator Site 8 - PL0480007
Katowice, 40-123
Investigator Site 9 - PL0480024
Krakow, 31-2002
Investigator Site 22 - PL0480005
Krakow, 31-505
Investigator Site 23 - PL0480018
Lublin, 20-093
Investigator Site 24 - PL0480022
Warsaw, 02-097
Georgia5 sites
Investigator site 13 - GE9950002
Tbilisi, 0112
Investigator site 12 - GE9950001
Tbilisi, 0114
Investigator site 14 - GE9950003
Tbilisi, 0114
Investigator Site 44 - GE9950004
Tbilisi, 0160
Investigator Site 45 - GE9950016
Tbilisi, 0160
Spain4 sites
Investigator Site 37 - ES0340021
Barcelona, 08035
Investigator Site 26 - ES0340038
Barcelona, 08041
Investigator Site 25 - ES0340002
Madrid, 28046
Investigator Site 10 - ES0340039
Valencia, 46026
Germany2 sites
Investigator Site 30 - DE490006
Berlin, 10117
Investigator Site 29 - DE490009
Münster, 48149
Hungary2 sites
Investigator site 15 - HU0360013
Budapest, 1082
Investigator Site 16 - HU0360020
Debrecen, 4032
Italy2 sites
Investigator Site 17 - IT0390003
Milan, 20133
Investigator Site 39 - IT0390008
Roma, 00189
Russia2 sites
Investigator Site 35 - RU0070002
Novosibirsk, 630087
Investigator Site 36 - RU0070014
Saint Petersburg, 194354
About this study
Official title: A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)
Read the detailed description
Main objective of the trial: To demonstrate that the pharmacodynamic (PD) effect of injections of 1000 mg efgartigimod PH20 SC (efgartigimod co-formulated with recombinant humanhyaluronidase PH20 for subcutaneous administration), administered once weekly for 4 administrations, is NI (noninferior) to IV infusions of efgartigimod (efgartigimod formulation for intravenous infusion) at a dose of 10 mg/kg administered once weekly for 4 administrations.
Secondary objectives: To compare the PD effect of efgartigimod PH20 SC and efgartigimod IV over time; To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC and efgartigimod IV; To evaluate the safety, tolerability, and immunogenicity of efgartigimod PH20 SC and efgartigimod IV; To evaluate the clinical efficacy of efgartigimod PH20 SC and efgartigimod IV.
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- efgartigimod PH20 SC, efgartigimod IV
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efgartigimod PH20 SCBiological
Subcutaneous injection with efgartigimod PH20 SC
efgartigimod IVBiological
Intravenous infusion of efgartigimod
| Study group | Role | What they receive |
|---|---|---|
| efgartigimod PH20 SC | Experimental | Patients receiving efgartigimod PH20 subcutaneous (SC) treatment Receives: Biological: efgartigimod PH20 SC |
| efgartigimod | Experimental | Patients receiving efgartigimod intravenous (IV) treatment Receives: Biological: efgartigimod IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)
ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).
Measured: From week 0 to week 4
Secondary outcomes (13)
Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)
Total IgG level percent change from baseline over time for the overall population.
Measured: From baseline to week 10
Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)
Percent reduction from baseline in AChR-Ab levels over time in AChR-Ab positive patients measured in mITT Analysis Set.
Descriptive statistics have been used for this secondary end point.
Measured: From baseline to week 10
Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)
Median (IQR) Percent Change From Baseline for the IgG Subtypes (IgG1, IgG2, IgG3, and IgG4) in the Overall Population.
The highest number of patients among all weeks for the analysis is chosen for each arm.
Descriptive statistics have been used for this secondary end point.
Measured: Baseline to week 10
AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)
AUEC of the percent reduction from baseline total IgG per dosing interval (days 1-8, days 8-15, days 15-22, and days 22-29), days 1-29, days 1-57 and over the entire study (days 1-71).
The highest number of patients among all weeks for the analysis is chosen for each arm.
Descriptive statistics have been used for this secondary end point.
Measured: From baseline to week 10
Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough
Evaluation of observed predose concentration (Ctrough) (after all doses for the IV and SC treatment arms). The analysis will present data from Week 1 to Week 4.
Descriptive statistics have been used for this secondary end point.
Measured: From Week 1 to Week 4.
Efgartigimod IV Serum Pharmacokinetic Parameter Cmax
Evaluation of maximum observed concentration (Cmax) (after all doses for the IV treatment arm). The analysis will present data from Baseline to Week 3.
Descriptive statistics have been used for this secondary end point.
Measured: From Baseline to Week 3
Incidence of ADA Against Efgartigimod (Safety Analysis Set)
Incidence of antidrug antibodies (ADA) against Efgartigimod in the overall population. ADA analysis is performed with a validated ELISA in a 3-tiered approach (ADA screening analysis, confirmatory analysis and a titration assay). Descriptive statistics have been used for this secondary end point.
Measured: From baseline to week 10
Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)
Incidence of antibodies against rHuPH20 in the Efgartigimod PH20 SC Arm. antibody analysis is performed with a validated ELISA in a 3-tiered approach (screening analysis, confirmatory analysis and a titration assay) Descriptive statistics have been used for this secondary end point.
Measured: From baseline to week 10
Incidence and Severity of AEs and SAEs (Safety Analysis Set)
Evaluation of incidence and severity of treatment-emergent adverse events (TEAEs) and incidence of serious AEs (SAEs).
Descriptive statistics have been used for this secondary end point.
Measured: From baseline to week 10
MG-ADL Responders (ITT Analysis Set)
Evaluation of number and percentage of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders in the overall population. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks. Descriptive statistics have been used for this secondary end point.
Measured: From baseline to week 10
QMG Responders (ITT Analysis Set)
Evaluation of number and percentage of Quantitative Myasthenia Gravis (QMG) responders in the overall population (ITT Analysis Set).
Descriptive statistics have been used for this secondary end point. One subject in the EFG IV arm had no post-baseline QMG assessment and thus was excluded from the denominator.
Measured: From Baseline to Week 10
Change From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)
Evaluation of MG-ADL Total Score Change from baseline over time for the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point.
The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks.
Measured: From baseline to week 10
Change From Baseline in QMG Score Over Time (ITT Analysis Set)
Evaluation of QMG Total Score change from baseline over time for the overall population (ITT Analysis Set). The QMG (Quantitative Myasthenia Gravis) quantifies disease severity based on impairments of body function and structures as defined by the International Classification of Functioning, Disability and Health. The QMG consists of 13 items that assess ocular, bulbar, and limb function. Six of the 13 items are timed endurance tests measured in seconds. Each item has a possible score from 0 to 3. The total possible score is 39, where higher total scores indicate more severe impairments. It is based on qualitative testing of specific muscle groups to assess limb function.
Descriptive statistics have been used for this secondary end point. A participant was considered a QMG responder if he/she showed a reduction of at least 3 points from baseline on the QMG score for at least 4 consecutive weeks.
Measured: From baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start5 Feb 2021
- Primary completion2 Nov 2021
- Study completion13 Dec 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.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by argenxThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735432
- Sponsor's protocol ID
- ARGX-113-2001
- Acronym
- ADAPTsc
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2021
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT04735432
- Acronym / sponsor ID
- ADAPTsc / ARGX-113-2001
- Conditions
- Generalized Myasthenia Gravis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Posted 28 Feb 2023
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 investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)
Detailed description
Main objective of the trial: To demonstrate that the pharmacodynamic (PD) effect of injections of 1000 mg efgartigimod PH20 SC (efgartigimod co-formulated with recombinant humanhyaluronidase PH20 for subcutaneous administration), administered once weekly for 4 administrations, is NI (noninferior) to IV infusions of efgartigimod (efgartigimod formulation for intravenous infusion) at a dose of 10 mg/kg administered once weekly for 4 administrations.
Secondary objectives: To compare the PD effect of efgartigimod PH20 SC and efgartigimod IV over time; To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC and efgartigimod IV; To evaluate the safety, tolerability, and immunogenicity of efgartigimod PH20 SC and efgartigimod IV; To evaluate the clinical efficacy of efgartigimod PH20 SC and efgartigimod IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| efgartigimod PH20 SC | Experimental | Biological: efgartigimod PH20 SCPatients receiving efgartigimod PH20 subcutaneous (SC) treatment |
| efgartigimod | Experimental | Biological: efgartigimod IVPatients receiving efgartigimod intravenous (IV) treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- At least 18 years of age at the time of signing the informed consent form.
- Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by at least 1 of the following:
- Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb
Key exclusion criteria (11 listed)
- Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of Investigational Medicinal Product.
- Has any of the following medical conditions:
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 |
|---|---|---|
| efgartigimod PH20 SCSubcutaneous injection with efgartigimod PH20 SC | Biological | efgartigimod PH20 SC |
| efgartigimod IVIntravenous infusion of efgartigimod | Biological | efgartigimod |
Primary outcome
Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)
Time frame: From week 0 to week 4
ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).
13 secondary outcomes
Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)
Time frame: From baseline to week 10
Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)
Time frame: From baseline to week 10
Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)
Time frame: Baseline to week 10
AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)
Time frame: From baseline to week 10
Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough
Time frame: From Week 1 to Week 4.
Efgartigimod IV Serum Pharmacokinetic Parameter Cmax
Time frame: From Baseline to Week 3
Incidence of ADA Against Efgartigimod (Safety Analysis Set)
Time frame: From baseline to week 10
Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)
Time frame: From baseline to week 10
Incidence and Severity of AEs and SAEs (Safety Analysis Set)
Time frame: From baseline to week 10
MG-ADL Responders (ITT Analysis Set)
Time frame: From baseline to week 10
QMG Responders (ITT Analysis Set)
Time frame: From Baseline to Week 10
Change From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)
Time frame: From baseline to week 10
Change From Baseline in QMG Score Over Time (ITT Analysis Set)
Time frame: From baseline to week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
47 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing efgartigimod PH20 SC and efgartigimod IV in people with Generalized Myasthenia Gravis, run by argenx at 47 sites in 11 countries.
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 8 inclusion and 11 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Japan, Poland, Georgia, Spain and 6 more countries. 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?
Yes. Results are posted in the registry (first posted 28 Feb 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?
Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) (time frame: From week 0 to week 4). 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 28 Feb 2023.