Baricitinib in Idiopathic Granulomatous Mastitis

Phase 2

Active, not recruiting

• Conditions: Mastitis Chronic; Idiopathic Granulomatous Mastitis
• Interventions: Drug: Baricitinib

• Registration Number: NCT05852171
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

This study will explore the mechanism of targeted drug in treatment of idiopathic granulomatous mastitis, and clarify the clinical classification and corresponding markers.

Detailed Description

This study is aimed to explore the treatment effect of baricitinib in idiopathic granulomatous mastitis (IGM), as well as the clinical classification, potential markers and underline etiology of the disease. The target population of interest in this study is patients with non-lactating mastitis, which require core needle biopsy pathology to indicate mastitis without any pathogen infection. When IGM was diagnosed and informed consent complete, low dose of daily 2mg baricitinib was taken orally as the monotherapy in this trial. Follow-up visits were sheduled at baseline (i.e. pretreatment) , 1,3,6 months after treatment, and then every 3 months thereafter until 2 years after treatment discontinuation when achieving complete response. At each follow-up visit, the biggest IGM lesion in each patient was measured by breast ultrasound and 12 inflammational cytokines in peripheral blood should be tested. The primary end point was the objective response rate (ORR) including clinical complete response rate (CR) and partial response rate (PR), and the secondary end point was the recurrence rate within 12 months after drug discontinuation when achieving CR, the degree of inflammation markers decline, and the toxicity and side effects of the drug.

Study Timeline

• Study First Submitted: 2023-04-23
• Study Start: 2023-05-04
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-10
• Status Verified: 2024-05
• Primary Completion: 2025-04-30
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baricitinib	Baricitinib	Baricitinib，2mg QD，oral use.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Until progression or recurrence, assessed up to approximately 24 months post-intervention	Objective response rate (ORR) was defined as the sum of complete response rate (CR) and partial response rate (PR). The largest IGM lesion was evaluated using breast ultrasound (BUS) according to RECIST v1.1 in two dimensions: length ("LGH" in cm) and height ("HGT" in cm). CR was defined as the complete resolution of target lesion confirmed by both physical examination (PE) and BUS, complete healing of skin ulcerations and sinuses, and normalization of 12 inflammatory biomarkers. PR required ≥50% reduction in abnormal inflammatory markers accompanied by at least one of the following criteria: (1) clinical improvement in erythema, edema, local hyperthermia, or pain; (2) ≥50% reduction in LGH or HGT measured by BUS; or (3) ≥75% healing of skin ulcerations and sinuses.

Secondary Outcome Measures

Name	Time	Method
12-month recurrence rate	Until progression, assessed up to approximately 24 months post-intervention	Relapse rate of IGM within 12 months after discontinuation of baricitinib when achiving CR, decreasing of 12 inflammation markers involving IL1β/IL2/IL4/IL6/IL8/IL10/IL17α/IL12P70/IFNα/IFNγ/TNFα.
Toxicity and side effects	Up to follow-up period, approximately 24 months post-intervention	Occurrence of adverse events (AEs) after baricitinib administered orally according to NCI CTCAE v5.0.

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China