NCT05016297

Efficacy and Safety of Baricitinib in Sjogren's Syndrome

Completed Phase 2 Last updated 11 March 2026

What this trial tests

Phase 2 trial testing Baricitinib in Sjogren's Syndrome in 87 participants. Completed in 22 November 2024.

Timeline

14 July 2022

Primary endpoint
22 August 2024

22 November 2024

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	87
Start date	14 July 2022
Primary completion	22 August 2024
Estimated completion	22 November 2024
Sites	1 location across China

Drugs / interventions tested

• Baricitinib (baricitinib) — full drug profile →
• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →

Conditions studied

• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 75, any sex, with Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
   Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
2. Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
   Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
3. Novel and potential future therapeutic options in systemic autoimmune diseases.
   Balogh L, Oláh K, Sánta S, Majerhoffer N, et al · · 2024 · cited 16× · PMID 38558805 · DOI 10.3389/fimmu.2024.1249500
4. Ruxolitinib inhibits IFNγ-stimulated Sjögren's salivary gland MSC HLA-DR expression and chemokine-dependent T cell migration.
   McCoy SS, Parker M, Gurevic I, Das R, et al · · 2022 · cited 16× · PMID 35218354 · DOI 10.1093/rheumatology/keac111
5. Role of JAK-STAT signaling pathway in pathogenesis and treatment of primary Sjögren's syndrome.
   Li M, Li M, Qiao L, Wu C, et al · · 2023 · cited 13× · PMID 37185152 · DOI 10.1097/cm9.0000000000002539
6. Comprehensive Profiling of Cytokines and Growth Factors: Pathogenic Roles and Clinical Applications in Autoimmune Diseases.
   Donniacuo A, Mauro A, Cardamone C, Basile A, et al · · 2025 · cited 9× · PMID 41009491 · DOI 10.3390/ijms26188921
7. Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.
   Fox RI, Fox CM, McCoy SS. · · 2023 · cited 9× · PMID 37127914 · DOI 10.1080/14728214.2023.2209720
8. A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren's syndrome patients.
   Bai W, Yang F, Xu H, Wei W, et al · · 2023 · cited 8× · PMID 36793118 · DOI 10.1186/s13063-023-07087-5