Efficacy and Safety of Baricitinib in Sjogren's Syndrome

NCT05016297 | Completed Phase 2 FDA Drug

• 1 other identifier: PekingUMCH-HS-3023D
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators had observed that baricitinib was effective and safe in active pSS patients in a pilot study. So the investigators plan to conduct a multi-center, prospective, open-label, randomized study to evaluate the efficacy and safety of baricitinib in active pSS patients. The participants will be randomized (1:2) to receive HCQ (200mg twice a day) or baricitinib (4mg per day) with or without HCQ (200mg twice a day) until week 24. The primary endpoint is the ESSDAI and ESSPRI response (define as an improvement of ESSDAI at least three points, and ESSPRI at least one point or 15%) at 12 weeks. According to an expected response rate of 70% in baricitinib + HCQ group and 30% in HCQ group, the investigators will involve approximately 87 participants (29:58) with 20% drop out rate. The investigators will switch HCQ to baricitinib + HCQ if the participants has no response at 12 weeks. The investigators hypothesized that baricitinib was effective and safe in active pSS patients.

Conditions

Sjogren's Syndrome

Keywords

Sjogren's Syndrome; JAK inhibitor; baricitinib; ESSDAI

Outcome Measures

Primary Outcomes (1)

• Rate of MCII of ESSDAI

  The rate of ESSDAI response, or clinically important improvement (MCII) of ESSDAI, which was defined as an improvement of ESSDAI at least three points.

  12 weeks

Secondary Outcomes (10)

• Rate of MCII of ESSDAI

  24 weeks

• Rate MCII of ESSPRI

  12 and 24 weeks

• Change of PGA score

  12 and 24 weeks

• Change of C-reactive protein (CRP) level

  12 and 24 weeks

• Change of erythrocyte sedimentation rate (ESR) level

  12 and 24 weeks

Study Arms (2)

baricitinib 4mg per day

EXPERIMENTAL

Regardless of whether they are receiving HCQ, patients in this group will be given baricitinib 4 mg once daily.

Drug: Baricitinib

HCQ 200mg twice a day

ACTIVE COMPARATOR

Patients in this group will be given HCQ 200mg twice a day for 12 weeks. Patients who has no response to HCQ treatment alone at week 12 will be switched to baricitinib + HCQ group and added on baricitinib 4mg per day until the end of the study (week 24).

Drug: Hydroxychloroquine

Interventions

Baricitinib DRUG

baricitinib 4mg per day

baricitinib 4mg per day

Hydroxychloroquine DRUG

Hydroxychloroquine 200mg twice a day

HCQ 200mg twice a day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must read and understand the informed consent approved by the institutional review board (IRB)/ethics review board (ERB) governing the site and provide written informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Ability to take oral medication and be willing to adhere to the study intervention regimen.
• Male or female, aged between 18-75 years.
• Fulfill the 2016 ACR/EULAR classification criteria for primary Sjogren's Syndrome.
• With moderate activity (ESSDAI≥5) at the screening visit.
• Nonpregnant, nonbreastfeeding female patient
• Males with potential for reproduction must agree to practice effective birth control methods described above too.

You may not qualify if:

• Have received any of the following medications:
• Biologic treatments for immunologic disease such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, ustekinumab, ixekizumab, secukinumab, or anakinra within 4 weeks of screening.
• Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-IFN therapy) within 12 weeks of screening.
• Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg), or pulse methylprednisolone within 24 weeks of screening.
• Have received treatment with glucocorticoids, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus within 4 weeks at the time of screening.
• Have received plasmapheresis within 12 weeks of screening.
• Have received hemodialysis, peritoneal dialysis, or intestinal dialysis.
• History of chronic liver disease or elevated LFTs:
• ALT or AST \> 2 x upper limit of normal at screening
• Serum total bilirubin ≥ 1.5 x upper limit of normal at screening
• eGFR \<40 mL/min/1.73 m2 (Bedside Schwartz formula 2009).
• Protein to creatinine ratio of more than 1mg/dL repeated and confirmed three times or confirmed with 24 hours urine protein of more than 1000 mg.
• WBC\<2000/microliter or ANC\<1,000/microliter, Hgb\<9.0 g/dL or platelets \<100,000/microliter or absolute lymphocyte count\< 500/microliter.
• Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population that, in the opinion of the investigator, pose an unacceptable risk for the patient's participation in the study. Patients who are receiving thyroxine as replacement therapy may participate in the study, provided stable therapy has been administered for ≥12 weeks and TSH is within the laboratory's reference range. Patients who have TSH marginally outside the laboratory's normal reference range and are receiving stable thyroxine replacement therapy may participate if the treating physician has documented that the thyroxine replacement therapy is adequate for the patient.
• Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Bai W, Yang F, Xu H, Wei W, Li H, Zhang L, Zhao Y, Shi X, Zhang Y, Zeng X, Leng X. A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren's syndrome patients. Trials. 2023 Feb 15;24(1):112. doi: 10.1186/s13063-023-07087-5.

  PMID: 36793118 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

baricitinib; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaomei Leng, Dr.

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: August 23, 2021
• Study Start: July 14, 2022
• Primary Completion: August 22, 2024
• Study Completion: November 22, 2024
• Last Updated: March 11, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 5 years after article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to lengxm@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)