Primary Sjögren's SyndromePhase 2Rho plusNCT06203457
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
A Phase 2 study testing Efgartigimod in people with Primary Sjögren's Syndrome, run by argenx at 11 sites in 3 countries.
Trial summary
Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- Efgartigimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 29 Nov 2023to 3 Feb 2025
- Phase
- Phase 2
- 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
- Is at least the legal age of consent for clinical trials when signing the ICF
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP
- Has completed the qualifying efgartigimod SjD studies and agrees to continue study drug treatment without interruption in the extension study
Who cannot join
- Clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Pregnant or intention to become pregnant during the study
- Any severe systemic SjD manifestation that may put the participant at undue risk based on the investigator's opinion
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Poland8 sites
MCBK SC
Grodzisk Mazowiecki, 05 825
Centrum Medyczne Plejady
Krakow, 30 363
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
Poznan, 60-848
Centrum Medyczne Pratia Poznan
Skorzewo, 60 185
MICS Centrum Medyczne Warszawa
Warsaw, 00 874
Klinika Reuma Park Sp zoo Sp K
Warsaw, 02 665
Narodowy Instytut Geriatrii
Warsaw, 02637
FutureMeds sp zoo
Wroclaw, 50 088
Hungary2 sites
Debreceni Egyetem
Debrecen, 4032
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Székesfehérvár, 8000
About this study
Official title: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies
Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod study (ARGX-113-2106).
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Efgartigimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfgartigimodBiological
Patients receiving efgartigimod infusions
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod | Experimental | All participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. Receives: Biological: Efgartigimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With TEAEs, TESAEs and TEAESIs
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. Adverse events in the 'Infections and infestations' SOC were defined as AE of Special Interest (AESIs) because efgartigimod causes a transient reduction in total IgG levels.
Measured: From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks
Secondary outcomes (14)
Number of CRESS Responders at Weeks 24 and 48
A composite of relevant endpoints for Sjögren's syndrome (CRESS) measures systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function, and serology, developed to assess treatment efficacy in participants with SjD. A responder is defined as improvement in at least 3 of the above mentioned 5 items of CRESS. The score ranges from 0 to 9 (higher score = worse symptoms). Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations.
Measured: Weeks 24 and 48
Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48
European alliance of associations for rheumatology (EULAR) SjD activity index (ESSDAI) measures systemic disease activity in 12 domains. The activity levels of each domain are multiplied by their respective weights to obtain the total score between 0 and 123 (higher score = worse symptoms). Minimally clinically important improvement in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Weeks 24 and 48. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. Responder rates for the efg-efg group in the follow-up study are supplemental to those in the ARGX-113-2106 study. Because responders from the ARGX-113-2106 study (mainly in the efg-efg group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations.
Measured: Baseline (Day 1) and Weeks 24 and 48
Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48
ESSDAI measures systemic disease activity in participants with SjD and consists of 12 domains. The activity levels of each domain (range: 0-3 points) are multiplied by their respective weights (range: 1-6 points) to obtain the total score between 0 and 123 (higher score = worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Weeks 24 and 48. Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations.
Measured: Weeks 24 and 48
Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48
Clinical EULAR Sjögren's syndrome disease activity index (clinESSDAI) includes same 11 organ-specific domains as ESSDAI but with different domain weighting and this scale does not have biological domain.This way any change in clinESSDAI score reflects disease specific features irrespective of B-cell activity. clinESSDAI score ranges between 0-135 (higher score=worse symptoms).Minimal clinically important improvement in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Weeks 24 and 48.Baseline=last available non-missing measurement from parent study ARGX-113-2106.Responder rates for efgartigimod-efgartigimod group in follow-up study are supplemental to those in antecedent study (ARGX-113-2106).Because responders from ARGX-113-2106 study (mainly in efgartigimod-efgartigimod group) potentially started ARGX-113-2211 with lower baseline scores,further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations.
Measured: Baseline (Day 1) and Weeks 24 and 48
Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48
clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and this scale does not have the biological domain. This way any change in clinESSDAI score reflects disease specific features irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Low disease activity in clinESSDAI was defined as clinESSDAI score of less than 5 at Weeks 24 and 48. Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations.
Measured: Weeks 24 and 48
Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48
EULAR Sjögren's syndrome patient-reported index (ESSPRI) is a questionnaire developed to measure self-reported symptoms in participants with SjD and consists of 3 items that measure dryness, fatigue, and pain. The total global score ranges from 0 to 10 by averaging the numeric scores for pain, fatigue, and dryness, with higher scores indicating more symptoms. Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least >=15% at Weeks 24 and 48. Baseline was defined as the last available non-missing measurement from the study ARGX-113-2106. Responder rates for the efg-efg group in the follow-up study are supplemental to those in the ARGX-113-2106 study. Because responders from the ARGX-113-2106 study (mainly in the efg-efg group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this measure is inherently challenging due to biological and clinical limitations.
Measured: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in ESSDAI Score at Weeks 24 and 48
ESSDAI measures systemic disease activity in participants with SjD and consists of 12 domains: 11 organ-specific domains (cutaneous, pulmonary, renal, articular, muscular, peripheral nervous system, central nervous system, hematological, glandular, constitutional, and lymphadenopathic) and 1 biological domain reflecting B-cell activity that contributes to disease activity level scoring. The activity levels of each domain (range: 0-3 points) are multiplied by their respective weights (range: 1-6 points) to obtain the total score between 0 and 123 (higher score = worse symptoms). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106.
Measured: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in clinESSDAI Score at Weeks 24 and 48
clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and this scale does not have the biological domain. This way any change in clinESSDAI score reflects disease specific features irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106.
Measured: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in ESSPRI Score at Weeks 24 and 48
ESSPRI is a questionnaire developed to measure self-reported symptoms in participants with SjD and consists of 3 items that measure dryness, fatigue, and pain. Each item includes a numeric rating scale ranging from 0: no symptoms (dryness, fatigue, or pain) to 10: maximal imaginable (dryness, fatigue, or pain). The total global score ranges from 0 to 10 and the ESSPRI is calculated by averaging the numeric scores for pain, fatigue, and dryness, with higher scores indicating more symptoms. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106.
Measured: Baseline (Day 1) and Weeks 24 and 48
Number of STAR Responders at Weeks 24 and 48
Sjögren's tool for assessing response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a participant with a score of at least 5 points. Due to the weighting, participant must be a responder on either systemic disease activity (ESSDAI), patient-reported symptoms (ESSPRI), or both to be an overall STAR responder. The score ranges between 0 and 9 (higher score = worse outcome). Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations.
Measured: Weeks 24 and 48
Percent Change From Baseline in Total IgG Levels in Serum at Week 48
Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum. Total IgG concentrations were quantified using validated methods at a diagnostical laboratory. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106.
Measured: Baseline (Day 1) and Week 48
Percent Change From Baseline in Autoantibodies in Serum at Week 48
Blood samples were collected at indicated timepoints to assess serum autoantibodies: anti-Ro/Sjögren's syndrome-related antigen A (SS-A) and anti-La/Sjögren's syndrome-related antigen B (SS-B). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106.
Measured: Baseline (Day 1) and Week 48
Serum Concentrations of Efgartigimod
Serum samples were collected at indicated timepoints to assess the pharmacokinetic (PK) profile of efgartigimod.
Measured: Pre-dose and post-dose at Baseline (Day 1) and pre-dose at Weeks 24 and 48
Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period
Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. Samples were analyzed by the designated laboratory in a 3-tiered approach using validated immunogenicity assays. ADA incidence included total number of participants with treatment-boosted and treatment-induced ADA. Treatment-boosted ADA was defined as participants who had a baseline positive sample and the titer value increased 4-fold or more compared to baseline. Treatment-induced ADA was defined as participants who had a baseline negative sample and at least 1 positive post-baseline samples. Number of participants with ADA incidence is presented here.
Measured: From Baseline (Day 1) up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start29 Nov 2023
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
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 Primary Sjögren's SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203457
- Sponsor's protocol ID
- ARGX-113-2211
- Acronym
- Rho plus
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2023
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies
- ClinicalTrials.gov ID
- NCT06203457
- Acronym / sponsor ID
- Rho plus / ARGX-113-2211
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod study (ARGX-113-2106).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod | Experimental | Biological: EfgartigimodAll participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least the legal age of consent for clinical trials when signing the ICF
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP
- Has completed the qualifying efgartigimod SjD studies and agrees to continue study drug treatment without interruption in the extension study
Key exclusion criteria (3 listed)
- Clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Pregnant or intention to become pregnant during the study
- Any severe systemic SjD manifestation that may put the participant at undue risk based on the investigator's opinion
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 |
|---|---|---|
| EfgartigimodPatients receiving efgartigimod infusions | Biological | Efgartigimod |
Primary outcome
Number of Participants With TEAEs, TESAEs and TEAESIs
Time frame: From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. Adverse events in the 'Infections and infestations' SOC were defined as AE of Special Interest (AESIs) because efgartigimod causes a transient reduction in total IgG levels.
14 secondary outcomes
Number of CRESS Responders at Weeks 24 and 48
Time frame: Weeks 24 and 48
Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48
Time frame: Weeks 24 and 48
Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48
Time frame: Weeks 24 and 48
Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in ESSDAI Score at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in clinESSDAI Score at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in ESSPRI Score at Weeks 24 and 48
Time frame: Baseline (Day 1) and Weeks 24 and 48
Number of STAR Responders at Weeks 24 and 48
Time frame: Weeks 24 and 48
Percent Change From Baseline in Total IgG Levels in Serum at Week 48
Time frame: Baseline (Day 1) and Week 48
Percent Change From Baseline in Autoantibodies in Serum at Week 48
Time frame: Baseline (Day 1) and Week 48
Serum Concentrations of Efgartigimod
Time frame: Pre-dose and post-dose at Baseline (Day 1) and pre-dose at Weeks 24 and 48
Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period
Time frame: From Baseline (Day 1) up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Primary Sjögren's Syndrome
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
RecruitingPhase 3
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Primary Sjogren's Disease
Active, not recruitingPhase 2
A Study of RSLV-132 in Females With Sjögren's Disease
Primary Sjögren Syndrome
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.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efgartigimod in people with Primary Sjögren's Syndrome, run by argenx at 11 sites in 3 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 4 inclusion and 3 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, Hungary, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Feb 2026). 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?
Number of Participants With TEAEs, TESAEs and TEAESIs (time frame: From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks). 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 20 Feb 2026.