Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

NCT06862284 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: pss2024upa
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Sjögren's Syndrome (pSS)

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (5)

• Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score during treatment

  week 4, 12, 24, 52

• Change From Baseline in EULAR SS patient-reported index (ESSPRI) during treatment

  week 4, 12, 24, 52

• Variation of lymphocyte subpopulations during the treatment of upadacitinib

  week 4, 12, 24, 52

• Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib

  week 4, 12, 24, 52

• Change in quality of life(QOL) measured by 5-level EQ-5D version (EQ-5D-5L) compared with baseline

  week 4, 12, 24, 52

Study Arms (2)

upadacitinib group

EXPERIMENTAL

Participants will receive upadacitinib 15 milligrams (mg) orally once daily for 52 weeks.

Drug: Upadacitinib (ABT-494)

hydroxychloroquinone group

ACTIVE COMPARATOR

Participants will receive hydroxychloroquine 200 milligrams (mg) orally twice daily for 52 weeks.

Drug: Hydroxychloroquine (HCQ)

Interventions

Upadacitinib (ABT-494) DRUG

Upadacitinib 15mg Qd for 52 weeks

upadacitinib group

Hydroxychloroquine (HCQ) DRUG

Hydroxychloroquine 200mg Bid for 52 weeks

hydroxychloroquinone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Ongoing infections at Week 0 that have not been successfully treated.
• \. 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.
• \. 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).
• \. 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.
• \. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib).
• \. Exposure to biological DMARDs in two months before screening.
• \. Enrollment in another interventional clinical study while participating in this study.
• \. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive the study drug.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, China, 100044, China

Location

MeSH Terms

Interventions

upadacitinib; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jing He

  Peking University Institute of Rheuamotology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyu He

CONTACT

+86 19947570486; heshiyu@stu.pku.edu.cn

Jing He

CONTACT

+86 18611707347; hejing1105@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 11, 2025

Record last verified: 2024-12

Locations

CN (1)