NCT04077736

Low-dose Recombinant Human IL-2 for the Treatment of Relapsing Polychondritis

A Pilot Study of Low Dose IL-2 in the Treatment of Relapsing Polychondritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Relapsing polychondritis (RP) is a rare, systemic autoimmune disorder characterized by episodic inflammation of cartilaginous structures. Pro-inflammatory chemokines involved in the recruitment of monocytes and modulation of macrophage function, such as monocyte chemoattractant protein-1, macrophage inflammatory protein 1β, and interleukin (IL)-8, are significantly elevated in active RP compared with controls.The activation of monocytes and macrophages may play an important role in the pathophysiology of RP. The levels of serum Th1 cytokines (interferon, IL-2 (IL-2) and IL-12 (IL-12) were significantly correlated with disease status，which suggested that RP may be a Th1-mediated disease process. IL-2 is a kind of lymphocyte growth factor. At lower doses, regulatory T cells exhibit dominant amplification because of their more sensitivity to IL-2. Regulatory T cells can inhibit the growth of effector T cells and then play an immunosuppressive role. The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RP patients. This clinical study will explore the efficacy and immunological evaluation of low dose IL-2 in the treatment of RP.

Detailed description

Ten patients with active RP at 18 to 70 years of age were enrolled. Without changing the original treatment plan, IL-2 1 million units was administered subcutaneously five days every week for 4 weeks and then once a week for 8 weeks. The clinical symptoms, disease score scale, laboratory parameters, immune cell subsets and cytokines should be monitored during the treatment.

Conditions

• Relapsing Polychondritis

Interventions

Type	Name	Description
DRUG	Interleukin-2	low dose interleukin-2 injected subcutaneously, at a dose of 1 million IU five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-10-10
• Completion: 2023-10-30
• First posted: 2019-09-04
• Last updated: 2024-02-26

Locations

1 site across 1 country: China