NCT07325357

Effect of Pirfenidone on TA Fibrosis

A Single-center, Randomized, Double-blind, Controlled Study Comparing the Efficacy and Safety of Pirfenidone Versus Placebo in the Treatment of Takayasu Arteritis on the Basis of Conventional Immunosuppressive Therapy

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Takayasu arteritis is a severe vasculitis which could lead to significant disability and even death. While standard anti-inflammatory treatments can manage the systemic inflammation, they failed to stop a key driver of the disease: vascular fibrosis. This fibrosis could result in blood vessels thickening and narrowing, which continues to progress in many patients. To tackle this critical treatment gap, the present project explores a new strategy. Building on pirfenidone's success in treating fibrosis in organs just like lungs and liver, along with promising early observations from our center, investigators believe adding this anti-fibrotic drug to standard therapy could improve vessel injury directly. Therefore, investigators plan to conduct a clinical trial comparing pirfenidone with placebo in patients with Takayasu arteritis. The goal is to determine if this approach can successfully improve vascular injury and patient outcomes ultimately.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Pirfenidone Capsules	pirfenidone 400mg.tid.po, escalated to 600mg.tid.po if acceptable in patients.
DRUG	Placebo	Placebo capsules for pirfenidone.

Timeline

• Start date: 2025-12-20
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2026-01-08
• Last updated: 2026-01-08