NCT05016297

Efficacy and Safety of Baricitinib in Sjogren's Syndrome

A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All participants will be divided into HCQ group or baricitinib group randomly. Regardless of whether they are receiving HCQ, the participants in the latter group will be given baricitinib 4mg once a day. The participants will come to visit at week 0, 4, 8, 12, 16, 20 and 24. The final evaluation will be at week 24. The participants who has no response to HCQ treatment alone at week 12 will be switched to baricitinib group and treated with baricitinib 4mg per day until the end of the study (week 24). Baseline information included demographics, SS duration, clinical manifestations, laboratory parameters, current medications, and disease activity. Laboratory tests, including complete blood counts, urinalysis, liver and renal function tests, ESR, and IgG test were performed at each visit. Disease activity was assessed using the ESSDAI, EULAR primary SS patient reported index (ESSPRI), and physician global assessment (PGA) scores.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Baricitinib	baricitinib 4mg per day
DRUG	Hydroxychloroquine	Hydroxychloroquine 200mg twice a day

Timeline

• Start date: 2022-07-14
• Primary completion: 2024-08-22
• Completion: 2024-11-22
• First posted: 2021-08-23
• Last updated: 2026-03-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study