Primary Sjögren's SyndromePhase 2rhoNCT05817669
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
A Phase 2 study testing Efgartigimod in people with Primary Sjögren's Syndrome, run by argenx at 17 sites in 4 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS. 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?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 4 Apr 2023to 12 Feb 2024
- 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 informed consent form
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol
- Meets the following criteria at screening: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening; ESSDAI ≥5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10)
Who cannot join
- Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
- History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP.
- Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
- Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of <200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of >200 cells/mm3 not adequately treated with antiviral therapy
- Clinically significant disease, recent major surgery (within 3 months of screening), 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
- Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)
Show all 14Show fewer
- Positive covid test at study start
- Some of the medications such as vaccines with live components or medicines that may be prescribed cannot be taken either shortly before or during this study
- Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP
- Known hypersensitivity to IMP or 1 of its excipients
- History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator
- Pregnant or lactating state or intention to become pregnant during the study
- Secondary Sjögren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis
- Chinese traditional medicine with known immunomodulatory action
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Poland13 sites
Ambulatorium Barbara Bazela
Elblag, 82-300
MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
Grodzisk Mazowiecki, 05-825
Centrum Medyczne Plejady
Krakow, 30-363
FutureMeds Krakow
Krakow, 31-501
ETG Lublin
Lublin, 20-412
Reumed Spolka z o.o.
Lublin, 20-607
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
Poznan, 60-848
Centrum Medyczne Pratia Poznan
Skórzewo, 60-185
MICS Centrum Medyczne Warszawa
Warsaw, 00-874
KO-Med - Centrum Badań Medycznych NIGRiR
Warsaw, 02-637
Centrum Medyczne Reuma Park
Warsaw, 02-691
FutureMeds Targowek
Warsaw, 03-291
FutureMeds Wroclaw
Wroclaw, 50-088
Hungary2 sites
Debreceni Egyetem
Debrecen, 4032
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Székesfehérvár, 8000
Netherlands1 site
Universitair Medisch Centrum Groningen , Dept of Rheumatology and Clinical Immunology
Groningen, 9713 GZ
About this study
Official title: A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
Read the detailed description
Primary Sjogren Syndrome (pSS) is an autoimmune disease with still unmet treatment needs. Efgartigimod, a human FcRn antagonist, has the potential to successfully treat pSS and improve disease manifestations by the reduction of IgG autoantibodies and immune complexes in pSS. The study design is randomized, double-blinded, and placebo-controlled to evaluate the effect of efgartigimod administered as an IV infusion compared to placebo. The study consists of a treatment period when all participants will receive infusions of IP/placebo for 24 weeks. At the end of the randomized treatment period, eligible participants may roll over to an OLE study or remain in this study through the end of the 56-day follow-up period.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Efgartigimod, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfgartigimodBiological
Patients receiving efgartigimod infusions
PlaceboBiological
Patients receiving placebo infusions
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod IV arm | Experimental | patients receiving infusions of Efgartigimod IV Receives: Biological: Efgartigimod |
| Placebo arm | Placebo comparator | patients receiving infusions of placebo IV Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24
A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms).
Measured: Week 24
Secondary outcomes (13)
Number of Participants With TEAEs, AESI, and SAEs
A treatment-emergent adverse event (TEAE): adverse events reported from the first dose up to and including 60 days after the final dose were considered treatment-emergent. Serious adverse event (SAE): adverse event that 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 other situations. Adverse event of special interest (AESI): adverse event related to 'Infections and infestations'.
Measured: Up to 32 weeks
Percentage of Participants With MCII in ESSDAI at Week 24
European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Minimally clinically important improvement (MCII) in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Week 24.
Measured: Week 24
Percentage of Participants With Low Disease Activity in ESSDAI at Week 24
ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Week 24.
Measured: Week 24
Percentage of Participants With MCII in clinESSDAI at Week 24
Clinical (clin)ESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Minimal clinically important improvement (MCII) in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Week 24.
Measured: Week 24
Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24
clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect 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 Week 24.
Measured: Week 24
Percentage of Participants With MCII in ESSPRI at Week 24
Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least ≥15% at Week 24. ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms).
Measured: Week 24
Change From Baseline in ESSDAI Score at Week 24
ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score = worse symptoms).
Measured: Baseline (Day 1) and Week 24
Change From Baseline in clinESSDAI Score at Week 24
clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms).
Measured: Baseline (Day 1) and Week 24
Change From Baseline in ESSPRI Score at Week 24
ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms).
Measured: Baseline (Day 1) and Week 24
Percentage of Participants With STAR Score of at Least 5 at Week 24
Sjögren's Tool for Assessing Response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a score of at least 5 points. Due to the weighting, participants 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).
Measured: Week 24
Plasma Concentration of Efgartigimod
Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod.
Measured: Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage Change From Baseline in Total IgG Levels in Serum at Week 24
Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum.
Measured: Baseline (Day 1) and Week 24
Number of Participants With ADA Against Efgartigimod in Serum
Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. 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. Treatment-unaffected ADA was defined as participants who had a baseline positive sample, but the titer value did not increase 4-fold or more compared to baseline.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start4 Apr 2023
- Primary completion29 Jan 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 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
- NCT05817669
- Sponsor's protocol ID
- ARGX-113-2106
- Other IDs
- 2021-005911-30
- Acronym
- rho
- Status last verified
- Jun 2025
- First submitted
- 1 Feb 2023
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peene I, Verstappen GM, Arends S, Kroese FGM, De Boeck K, Achten H, Papadopoulou D, Jacobs J, Bowen E, Teperov E, Meyvisch P, Fardipour P, Kelly A, Brahmbhatt J, Elewaut D, Bootsma H. Efgartigimod in Sjogren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO). Ann Rheum Dis. 2026 Jul;85(7):1341-1350. doi: 10.1016/j.ard.2026.03.019. Epub 2026 Apr 16.
PubMed 41997805
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT05817669
- Acronym / sponsor ID
- rho / ARGX-113-2106
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 18 Jul 2025
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 assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
Detailed description
Primary Sjogren Syndrome (pSS) is an autoimmune disease with still unmet treatment needs. Efgartigimod, a human FcRn antagonist, has the potential to successfully treat pSS and improve disease manifestations by the reduction of IgG autoantibodies and immune complexes in pSS. The study design is randomized, double-blinded, and placebo-controlled to evaluate the effect of efgartigimod administered as an IV infusion compared to placebo. The study consists of a treatment period when all participants will receive infusions of IP/placebo for 24 weeks. At the end of the randomized treatment period, eligible participants may roll over to an OLE study or remain in this study through the end of the 56-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod IV arm | Experimental | Biological: Efgartigimodpatients receiving infusions of Efgartigimod IV |
| Placebo arm | Placebo comparator | Biological: Placebopatients receiving infusions of placebo IV |
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 informed consent form
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol
- Meets the following criteria at screening: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening; ESSDAI ≥5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10)
Key exclusion criteria (14 listed)
- Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
- History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP.
- Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
- Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of <200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of >200 cells/mm3 not adequately treated with antiviral therapy
- Clinically significant disease, recent major surgery (within 3 months of screening), 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
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 IV arm |
| PlaceboPatients receiving placebo infusions | Biological | Placebo arm |
Primary outcome
Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24
Time frame: Week 24
A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms).
13 secondary outcomes
Number of Participants With TEAEs, AESI, and SAEs
Time frame: Up to 32 weeks
Percentage of Participants With MCII in ESSDAI at Week 24
Time frame: Week 24
Percentage of Participants With Low Disease Activity in ESSDAI at Week 24
Time frame: Week 24
Percentage of Participants With MCII in clinESSDAI at Week 24
Time frame: Week 24
Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24
Time frame: Week 24
Percentage of Participants With MCII in ESSPRI at Week 24
Time frame: Week 24
Change From Baseline in ESSDAI Score at Week 24
Time frame: Baseline (Day 1) and Week 24
Change From Baseline in clinESSDAI Score at Week 24
Time frame: Baseline (Day 1) and Week 24
Change From Baseline in ESSPRI Score at Week 24
Time frame: Baseline (Day 1) and Week 24
Percentage of Participants With STAR Score of at Least 5 at Week 24
Time frame: Week 24
Plasma Concentration of Efgartigimod
Time frame: Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage Change From Baseline in Total IgG Levels in Serum at Week 24
Time frame: Baseline (Day 1) and Week 24
Number of Participants With ADA Against Efgartigimod in Serum
Time frame: Up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41997805Peene I, Verstappen GM, Arends S, Kroese FGM, De Boeck K, Achten H, Papadopoulou D, Jacobs J, Bowen E, Teperov E, Meyvisch P, Fardipour P, Kelly A, Brahmbhatt J, Elewaut D, Bootsma H. Efgartigimod in Sjogren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO). Ann Rheum Dis. 2026 Jul;85(7):1341-1350. doi: 10.1016/j.ard.2026.03.019. Epub 2026 Apr 16.
- 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.
17 sites in 4 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 17 sites in 4 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 14 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Poland, Hungary, Belgium, Netherlands. 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. Some participants in this study may receive a placebo. 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 18 Jul 2025). 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 Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 (time frame: Week 24). 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 NCT05817669, 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 Jul 2025.