Sjogrens DiseasePhase 2SERENITYNCT07760818
A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)
A Phase 2 study testing efgartigimod PH20 SC in people with Sjogrens Disease and Primary Sjögren's Syndrome Painful Sensory Neuropathies, run by argenx.
Trial summary
This study aims to assess the efficacy and safety of efgartigimod PH20 in adults with Sjogren's Disease (SjD) associated with nerve damage. The study will assess how efgartigimod PH20 affects symptoms of SjD specifically linked to the peripheral nervous system; the safety and tolerability of efgartigimod PH20; and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogrens Disease, Primary Sjögren's Syndrome Painful Sensory Neuropathies
- What is being tested?
- efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2026to 28 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years of age and the local legal age of consent for clinical studies when signing the ICF
- Meets the following SjD criteria: Fulfilled American College of Rheumatology and the European Alliance of Associations for Rheumatology classification 2016 SjD criteria before screening; Moderate-to-severe disease defined as a ESSDAI ≥ 5 or clinESSDAI ≥ 6 with PNS domain score of ≥ 5 (ie, a score of at least low activity) at screening; Anti-Ro/SS-A positive at a central laboratory at screening
- Meets the following SjD-associated polyneuropathy criteria: Diagnosis of SjD-associated SMPN, SPN or sensory ganglionopathy, with neuropathy duration ≤ 5 years at screening and signs of active neuropathic disease development within the last 12 months; patients with co-existing SjD-associated small fiber neuropathy are eligible; No alternative diagnosis of neuropathy etiology; Total mTCNS ≥ 6 at screening; mTCNS sensory test score <level 3 at screening (does not apply to sensory ganglionopathy cohort where any severity is acceptable)
Who cannot join
- Besides the indication under study, known medical conditions that would interfere with an accurate assessment of clinical symptoms of SjD-associated SMPN or SPN or gangliopathy, confound the study results, or puts the participant at undue risk.
- Associated (also known as secondary) SjD, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy).
- Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
- An alternative etiology for SMPN/SPN/sensory ganglionopathy or insufficient evidence of the diagnosis.
- Any severe SjD manifestation or other health condition not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion.
- Comorbidities (eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic (oral, IV, or IM) glucocorticoids within the previous 12 months.
- History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years; before first IMP administration.
About this study
Official title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants With Sjogren's Disease-Associated Sensorimotor or Sensory Polyneuropathy
This study aims to assess the efficacy and safety of efgartigimod PH20 in adults with Sjogren's Disease (SjD) associated with nerve damage. The study will assess how efgartigimod PH20 affects symptoms of SjD specifically linked to the peripheral nervous system; the safety and tolerability of efgartigimod PH20; and whether receiving efgartigimod PH20 affects the participant's quality of life.
Read the detailed description
The study will be conducted in adult participants with moderate-to-severe SjD and SjD-associated sensorimotor polyneuropathy (SMPN) or sensory polyneuropathy (SPN). The study consists of two parts. Part A is a randomized, double-blinded, placebo-controlled, parallel-group treatment period designed to evaluate the efficacy and safety of efgartigimod hyaluronidase (PH20) subcutaneously (SC) or placebo. Following the completion of part A, the double-blinded treatment period (DBTP) participants will enter part B, an open-label treatment period (OLTP) to assess long-term safety, tolerability, and durability of response of efgartigimod PH20 SC.
The overall study duration will be up to 108 weeks for each participant.
- Being tested
- efgartigimod PH20 SC, Placebo PH20 SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efgartigimod PH20 SCBiological
subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SCOther
subcutaneous placebo PH20 SC given by prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| Double-blinded treatment period (DBTP): Efgartigimod PH20 SC | Experimental | Participants receiving efgartigimod PH20 SC during the double-blinded treatment period Receives: Biological: efgartigimod PH20 SC |
| Double-blinded treatment period (DBTP): Placebo PH20 SC | Placebo comparator | Participants receiving placebo PH20 SC during the double-blinded treatment period Receives: Other: Placebo PH20 SC |
| Open-label treatment period (OLTP) | Experimental | Participants receiving efgartigimod PH20 SC during the open-label treatment period Receives: Biological: efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score at the end of Part A
The mTCNS (modified Toronto Clinical Neuropathy Score) is a clinician-reported outcome measure derived from the original TCNS to improve sensitivity to early and mild neuropathy and to enhance feasibility and consistency inclinical research settings. The total mTCNS score is calculated as the sum of the symptom and sensory subscores, yielding a total possible score range of 0 to 33, with higher scores indicating greater neuropathy severity.
Measured: Up to 48 weeks
Secondary outcomes (13)
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score over time
The mTCNS (modified Toronto Clinical Neuropathy Score) is a clinician-reported outcome measure derived from the original TCNS to improve sensitivity to early and mild neuropathy and to enhance feasibility and consistency inclinical research settings. The total mTCNS score is calculated as the sum of the symptom and sensory subscores, yielding a total possible score range of 0 to 33, with higher scores indicating greater neuropathy severity.
Measured: up to 96 weeks
Change from baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) total score at the end of part A and over time
The Norfolk QoL-DN is a patient-reported outcome (PRO) instrument designed to assess neuropathy symptom severity and the impact of peripheral neuropathy on participants' ability to complete activities of daily living (ADLs). The Norfolk QoL-DN consists of 35 items that assess the presence and severity of sensory symptoms (eg, numbness, tingling, pain), motor and balance difficulties, and the extent to which neuropathy interferes with daily activities, sleep, work, and social functioning.
Measured: up to 96 weeks
Change from baseline in clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) score at the end of part A and over time
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) was designed to measure systemic disease activity in patients with SjD. The ESSDAI consists of 12 domains, and the final score falls between 0 (no disease activity) and, theoretically, 123 (maximum disease activity). Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) includes all ESSDAI domains except the biological domain. The clinical domains in clinESSDAI have different weights than in ESSDAI.
Measured: up to 96 weeks
Change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at the end of part A and over time
The ESSDAI was designed to measure systemic disease activity in patients with SjD. The ESSDAI consists of 12 domains, and the final score falls between 0 (no disease activity) and, theoretically, 123 (maximum disease activity).
Measured: up to 96 weeks
Proportion of participants with low disease activity (clinESSDAI < 5) at the end of part A and over time
The ESSDAI was designed to measure systemic disease activity in patients with SjD. The ESSDAI consists of 12 domains, and the final score falls between 0 (no disease activity) and, theoretically, 123 (maximum disease activity). clinESSDAI includes all ESSDAI domains except the biological domain. The clinical domains in clinESSDAI have different weights than in ESSDAI.
Measured: up to 96 weeks
Incidence of AEs
Incidents are identified by measuring clinically significant changes in vital signs, physical examination, ECG, and clinical laboratory safety evaluations.
Measured: Up to 104 weeks
Change from baseline in Neuropathic Pain Questionnaire (NPQ) at the end of part A and over time
The NPQ is a self-administered PRO used to characterize the qualitative features of neuropathic pain. Responses are combined using a predefined scoring algorithm to generate a summary score reflecting the presence and prominence of neuropathic pain features.
Measured: up to 96 weeks
Change from baseline in the Difficulty Thinking Numerical Rating Scale (NRS) at the end of part A and over time
The Difficulty Thinking Numerical Rating Scale (NRS) is a SjD-specific symptom severity diary that has been developed specifically for the purpose of assessing disease severity in participants with SjD. An 11-point Likert response scale is used from 0 (no difficulty thinking) to 10 (worst possible difficulty thinking).
Measured: up to 96 weeks
Change from baseline in Patient Global Impression of Severity (PGIS) scores at the end of part A and over time
The PGIS of neuropathy severity is a single-item questionnaire that asks participants to provide a self-assessment of their overall neuropathy severity, using a 5-point scale.
Measured: up to 96 weeks
Change from baseline in Patient Global Impression of Change (PGIC) scores at the end of part A and over time
The PGIC of neuropathy severity is a single-item questionnaire that asks the participant to provide a self-assessment of change in their neuropathy severity using a 7-point scale compared to just before the participant started taking the IMP.
Measured: up to 96 weeks
Change from baseline in Clinical Global Impression of Severity (CGIS) scores at the end of part A and over time
The CGI of SjD-associated SMPN or SPN severity is a 1-item questionnaire that asks the clinician to provide an assessment of their patients' neuropathy severity on a 5-point scale at the time of the visit.
Measured: up to 96 weeks
Change from baseline in Clinical Global Impression of Change (CGIC) scores at the end of part A and over time
The CGIC of SjD-associated SMPN or SPN severity is a 1-item questionnaire that asks the clinician to provide the overall change in their patients' neuropathy severity on a 7-point scale, compared to just before participant started taking the IMP.
Measured: up to 96 weeks
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scores at the end of part A and over time
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale assesses fatigue and its impact on patient's everyday lives, with a 7-day recall. It comprises 13 items, with responses of each of the items using a 5-point Likert scale ranging from 1 (Not at all) to 5 (Very much).
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start14 Aug 2026 (estimated)
- Primary completion28 Jul 2028 (estimated)
- Study completion28 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogrens DiseaseStudies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760818
- Sponsor's protocol ID
- argx-113-15-SJD-2003
- Other IDs
- 2026-526218-10-00
- Acronym
- SERENITY
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants With Sjogren's Disease-Associated Sensorimotor or Sensory Polyneuropathy
- ClinicalTrials.gov ID
- NCT07760818
- Acronym / sponsor ID
- SERENITY / argx-113-15-SJD-2003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (estimated)
- Primary completion
- 28 Jul 2028 (estimated)
- Study completion
- 28 Jul 2029 (estimated)
- First posted
- 12 Aug 2026 (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.
This study aims to assess the efficacy and safety of efgartigimod PH20 in adults with Sjogren's Disease (SjD) associated with nerve damage. The study will assess how efgartigimod PH20 affects symptoms of SjD specifically linked to the peripheral nervous system; the safety and tolerability of efgartigimod PH20; and whether receiving efgartigimod PH20 affects the participant's quality of life.
Detailed description
The study will be conducted in adult participants with moderate-to-severe SjD and SjD-associated sensorimotor polyneuropathy (SMPN) or sensory polyneuropathy (SPN). The study consists of two parts. Part A is a randomized, double-blinded, placebo-controlled, parallel-group treatment period designed to evaluate the efficacy and safety of efgartigimod hyaluronidase (PH20) subcutaneously (SC) or placebo. Following the completion of part A, the double-blinded treatment period (DBTP) participants will enter part B, an open-label treatment period (OLTP) to assess long-term safety, tolerability, and durability of response of efgartigimod PH20 SC.
The overall study duration will be up to 108 weeks for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-blinded treatment period (DBTP): Efgartigimod PH20 SC | Experimental | Biological: efgartigimod PH20 SCParticipants receiving efgartigimod PH20 SC during the double-blinded treatment period |
| Double-blinded treatment period (DBTP): Placebo PH20 SC | Placebo comparator | Other: Placebo PH20 SCParticipants receiving placebo PH20 SC during the double-blinded treatment period |
| Open-label treatment period (OLTP) | Experimental | Biological: efgartigimod PH20 SCParticipants receiving efgartigimod PH20 SC during the open-label treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF
- Meets the following SjD criteria: Fulfilled American College of Rheumatology and the European Alliance of Associations for Rheumatology classification 2016 SjD criteria before screening; Moderate-to-severe disease defined as a ESSDAI ≥ 5 or clinESSDAI ≥ 6 with PNS domain score of ≥ 5 (ie, a score of at least low activity) at screening; Anti-Ro/SS-A positive at a central laboratory at screening
- Meets the following SjD-associated polyneuropathy criteria: Diagnosis of SjD-associated SMPN, SPN or sensory ganglionopathy, with neuropathy duration ≤ 5 years at screening and signs of active neuropathic disease development within the last 12 months; patients with co-existing SjD-associated small fiber neuropathy are eligible; No alternative diagnosis of neuropathy etiology; Total mTCNS ≥ 6 at screening; mTCNS sensory test score <level 3 at screening (does not apply to sensory ganglionopathy cohort where any severity is acceptable)
Key exclusion criteria (7 listed)
- Besides the indication under study, known medical conditions that would interfere with an accurate assessment of clinical symptoms of SjD-associated SMPN or SPN or gangliopathy, confound the study results, or puts the participant at undue risk.
- Associated (also known as secondary) SjD, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy).
- Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
- An alternative etiology for SMPN/SPN/sensory ganglionopathy or insufficient evidence of the diagnosis.
- Any severe SjD manifestation or other health condition not adequately controlled at screening or baseline 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 |
|---|---|---|
| efgartigimod PH20 SCsubcutaneous efgartigimod PH20 SC given by prefilled syringe | Biological | Double-blinded treatment period (DBTP): Efgartigimod PH20 SC, Open-label treatment period (OLTP) |
| Placebo PH20 SCsubcutaneous placebo PH20 SC given by prefilled syringe | Other | Double-blinded treatment period (DBTP): Placebo PH20 SC |
Primary outcome
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score at the end of Part A
Time frame: Up to 48 weeks
The mTCNS (modified Toronto Clinical Neuropathy Score) is a clinician-reported outcome measure derived from the original TCNS to improve sensitivity to early and mild neuropathy and to enhance feasibility and consistency inclinical research settings. The total mTCNS score is calculated as the sum of the symptom and sensory subscores, yielding a total possible score range of 0 to 33, with higher scores indicating greater neuropathy severity.
13 secondary outcomes
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score over time
Time frame: up to 96 weeks
Change from baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) total score at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) score at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at the end of part A and over time
Time frame: up to 96 weeks
Proportion of participants with low disease activity (clinESSDAI < 5) at the end of part A and over time
Time frame: up to 96 weeks
Incidence of AEs
Time frame: Up to 104 weeks
Change from baseline in Neuropathic Pain Questionnaire (NPQ) at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in the Difficulty Thinking Numerical Rating Scale (NRS) at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in Patient Global Impression of Severity (PGIS) scores at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in Patient Global Impression of Change (PGIC) scores at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in Clinical Global Impression of Severity (CGIS) scores at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in Clinical Global Impression of Change (CGIC) scores at the end of part A and over time
Time frame: up to 96 weeks
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scores at the end of part A and over time
Time frame: up to 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing efgartigimod PH20 SC in people with Sjogrens Disease and Primary Sjögren's Syndrome Painful Sensory Neuropathies, run by argenx.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) total score at the end of Part A (time frame: Up to 48 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 12 Aug 2026.