Primary Sjögren's Syndrome (pSS)Phase 2NCT06862284
Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome
A Phase 2 study testing Upadacitinib (ABT-494) and Hydroxychloroquine (HCQ) in people with Primary Sjögren's Syndrome (pSS), run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is designed to explore the efficacy and safety of upadacitinib and clarify the influence on immune function in the treatment of primary Sjögren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- Upadacitinib (ABT-494) and Hydroxychloroquine (HCQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 31 Aug 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >18 years of age at screening visits
- Participants with diagnosis of pSS according to the 2016 ACR/EULAR criteria
- Participants have an ESSDAI score ≥ 5
- Participants must be on a stable dose of prednisone (≤10mg/day), antimalarials or equivalent, and cholinergic stimulants prior to Baseline.
- Participants previously on other immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, iguratimod) should have withdrawn drug for at least 8 weeks (56 days) at the time of screening
- If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive the study drug.
- If female, the subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
- The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
Who cannot join
- Any subject meeting any of the following criteria should be excluded:
- Pregnant or breastfeeding female.
- Diagnosis of other autoimmune disease, or other sicca syndrome.
- Laboratory value abnormality:
- (1)Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × upper limit of normal (ULN); (2)Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m^2; (3)Total white blood cell count (WBC) < 2,000/μL; (4)Absolute neutrophil count (ANC) < 1,000/μL; (5)Platelet count < 50,000/μL; (6)Absolute lymphocytes count < 500/μL; (7)Hemoglobin < 8 g/dL.
- 4. Ongoing infections at Week 0 that have not been successfully treated.
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- 5. Infection with HIV ( HIV antibody positive serological test ) or hepatitis C ( hepatitis C antibody positive serological test ). If the serum reaction is positive, it is recommended to consult a doctor with expertise in the treatment of HIV or hepatitis C virus infection.
- 6. History of any known malignancy in the last 5 years (except non-melanoma skin cancer, non-melanoma skin cancer or cervical tumors that have not recurred within 3 months after surgical cure prior to screening).
- 7. Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, hematological or neurological conditions, chronic or latent infectious diseases, or immune deficiency which places the patient at an unacceptable risk for participation in the study.
- 8. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib).
- 9. Exposure to biological DMARDs in two months before screening.
- 10. Enrollment in another interventional clinical study while participating in this study.
- 11. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, China, 100044
Jing He, MD and PhD, +8618611707347, hejing1105@gmail.com
About this study
Official title: Efficacy, Safety and Immunological Effect of Upadacitinib in the Treatment of Primary Sjögren's Syndrome
This study is designed to explore the efficacy and safety of upadacitinib and clarify the influence on immune function in the treatment of primary Sjögren's Syndrome.
Read the detailed description
This is an open-label, single-center, randomized controlled trial of upadacitinib in the treatment of active primary Sjögren's Syndrome. The enrollment was based on the American College of Rheumatology(ACR) and European League Against Rheumatism (EULAR)(2016) diagnostic criteria. The efficacy and safety were evaluated in participants given upadacitinib 15mg/day and a proper, stable dose of hydroxychloroquine 400mg/day. Changes in clinical manifestation, laboratory indexes, and immunological indicators were explored in the process.
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Being tested
- Upadacitinib (ABT-494), Hydroxychloroquine (HCQ)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib (ABT-494)Drug
Upadacitinib 15mg Qd for 52 weeks
Hydroxychloroquine (HCQ)Drug
Hydroxychloroquine 200mg Bid for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| upadacitinib group | Experimental | Participants will receive upadacitinib 15 milligrams (mg) orally once daily for 52 weeks. Receives: Drug: Upadacitinib (ABT-494) |
| hydroxychloroquinone group | Active comparator | Participants will receive hydroxychloroquine 200 milligrams (mg) orally twice daily for 52 weeks. Receives: Drug: Hydroxychloroquine (HCQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatent response assessed by the Sjögren's Tool for Assessing Response (STAR)
STAR is a new response assessment tool for pSS including 5 aspects: systemic activity, patient-reported outcomes, lacrimal gland function, salivary gland function, and biomarkers, which can evaluate treatment response in all patients with pSS, including those with low systemic activity but high symptom burden.
Response in system activity (3 points) is defined by a decrease of ≥3 in clinESSDAI and response in patient-reported outcome (3 points) is defined by a decrease of ≥1 point or 15% in ESSPRI. Response in lachrymal gland function (1 points) is assessed by Schirmer's test or ocular staining score. Response in Salivary gland function (1 points) was assessed by unstimulated whole salivary flow or ultrasound. Biological response (1 points) means decrease of serum IgG level ≥10% or decrease of RF level ≥25%. Candidate STAR responder is defined by total score of the above 5 domains ≥5.
Measured: week 24
Secondary outcomes (5)
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score during treatment
ESSDAI measures the disease activity of primary Sjögren's Syndrome from 12 aspects: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, biological involvement. The score of each domain is obtained by multiplying the activity level by the domain weight, and the weight range is 1 to 6, and a numerical score is assigned according to the weight of each domain determined in advance. The sum of all single weighted domain scores is the total score, ranging from 0 ( best ) to 123 ( worst ). The higher the score, the stronger the disease activity. A clinically significant decrease ( ≥ 3 points ) compared with the baseline indicates an improvement in symptoms.
Measured: week 4, 12, 24, 52
Change From Baseline in EULAR SS patient-reported index (ESSPRI) during treatment
ESSPRI was developed to assess patients' symptoms in primary Sjögren's Syndrome. It Includes three main symptoms, dryness, pain, and fatigue, and each with a score range of 0-10, and the ESSPRI score is the average of the three scores. A higher score indicated more severe symptoms.
Measured: week 4, 12, 24, 52
Variation of lymphocyte subpopulations during the treatment of upadacitinib
Lymphocyte subgroups of T cell and B cell are analyzed during the treatment.
Measured: week 4, 12, 24, 52
Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib
Measured: week 4, 12, 24, 52
Change in quality of life(QOL) measured by 5-level EQ-5D version (EQ-5D-5L) compared with baseline
The EQ-5D-5L is a health-related quality-of-life instrument developed by the EuroQol Group. It is designed to measure health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: week 4, 12, 24, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
- Investigators
- Jing He, Principal investigator, Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862284
- Sponsor's protocol ID
- pss2024upa
- Status last verified
- Dec 2024
- First submitted
- 1 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Immunological Effect of Upadacitinib in the Treatment of Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT06862284
- Acronym / sponsor ID
- pss2024upa
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Mar 2025 (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 is designed to explore the efficacy and safety of upadacitinib and clarify the influence on immune function in the treatment of primary Sjögren's Syndrome.
Detailed description
This is an open-label, single-center, randomized controlled trial of upadacitinib in the treatment of active primary Sjögren's Syndrome. The enrollment was based on the American College of Rheumatology(ACR) and European League Against Rheumatism (EULAR)(2016) diagnostic criteria. The efficacy and safety were evaluated in participants given upadacitinib 15mg/day and a proper, stable dose of hydroxychloroquine 400mg/day. Changes in clinical manifestation, laboratory indexes, and immunological indicators were explored in the process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upadacitinib group | Experimental | Drug: Upadacitinib (ABT-494)Participants will receive upadacitinib 15 milligrams (mg) orally once daily for 52 weeks. |
| hydroxychloroquinone group | Active comparator | Drug: Hydroxychloroquine (HCQ)Participants will receive hydroxychloroquine 200 milligrams (mg) orally twice daily for 52 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female >18 years of age at screening visits
- Participants with diagnosis of pSS according to the 2016 ACR/EULAR criteria
- Participants have an ESSDAI score ≥ 5
- Participants must be on a stable dose of prednisone (≤10mg/day), antimalarials or equivalent, and cholinergic stimulants prior to Baseline.
- Participants previously on other immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, iguratimod) should have withdrawn drug for at least 8 weeks (56 days) at the time of screening
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding female.
- Diagnosis of other autoimmune disease, or other sicca syndrome.
- Laboratory value abnormality:
- (1)Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × upper limit of normal (ULN); (2)Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m^2; (3)Total white blood cell count (WBC) < 2,000/μL; (4)Absolute neutrophil count (ANC) < 1,000/μL; (5)Platelet count < 50,000/μL; (6)Absolute lymphocytes count < 500/μL; (7)Hemoglobin < 8 g/dL.
- 4. Ongoing infections at Week 0 that have not been successfully treated.
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 |
|---|---|---|
| Upadacitinib (ABT-494)Upadacitinib 15mg Qd for 52 weeks | Drug | upadacitinib group |
| Hydroxychloroquine (HCQ)Hydroxychloroquine 200mg Bid for 52 weeks | Drug | hydroxychloroquinone group |
Primary outcome
Treatent response assessed by the Sjögren's Tool for Assessing Response (STAR)
Time frame: week 24
STAR is a new response assessment tool for pSS including 5 aspects: systemic activity, patient-reported outcomes, lacrimal gland function, salivary gland function, and biomarkers, which can evaluate treatment response in all patients with pSS, including those with low systemic activity but high symptom burden. Response in system activity (3 points) is defined by a decrease of ≥3 in clinESSDAI and response in patient-reported outcome (3 points) is defined by a decrease of ≥1 point or 15% in ESSPRI. Response in lachrymal gland function (1 points) is assessed by Schirmer's test or ocular staining score. Response in Salivary gland function (1 points) was assessed by unstimulated whole salivary flow or ultrasound. Biological response (1 points) means decrease of serum IgG level ≥10% or decrease of RF level ≥25%. Candidate STAR responder is defined by total score of the above 5 domains ≥5.
5 secondary outcomes
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score during treatment
Time frame: week 4, 12, 24, 52
Change From Baseline in EULAR SS patient-reported index (ESSPRI) during treatment
Time frame: week 4, 12, 24, 52
Variation of lymphocyte subpopulations during the treatment of upadacitinib
Time frame: week 4, 12, 24, 52
Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib
Time frame: week 4, 12, 24, 52
Change in quality of life(QOL) measured by 5-level EQ-5D version (EQ-5D-5L) compared with baseline
Time frame: week 4, 12, 24, 52
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 11 Mar 2025.
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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.
Jing He principal investigator
Peking University Institute of Rheuamotology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upadacitinib (ABT-494) and Hydroxychloroquine (HCQ) in people with Primary Sjögren's Syndrome (pSS), run by Peking University People's Hospital at 1 site in China.
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 13 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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
Contact Shiyu He (+86 19947570486, heshiyu@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatent response assessed by the Sjögren's Tool for Assessing Response (STAR) (time frame: week 24). 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 11 Mar 2025.