The Efficacy and Safety of Tocilizumab for Severe RP-ILD Secondary to Systemic Diseases

Phase 2

• Conditions: Rapid Progressive Interstitial Lung Diseases
• Interventions: Drug: Tocilizumab

• Registration Number: NCT05181397
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

There is no confirmed drug therapy for RP-ILD. Prognosis is poor of regular treatment. The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.

Detailed Description

RP-ILD, also known as the acute exacerbation of interstitial lung disease, was defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest imaging or histopathology. It is rapidly progressive and life-threatening. Despite aggressive regular treatments with high-dose glucocorticoids in combination with immunosuppressant drugs such as cyclosporine, tacrolimus, or cyclophosphamide, the post-exacerbation mortality rates remain high. There is no confirmed drug therapy for RP-ILD. Recently, the exacerbation of interstitial lung diseases secondary to systemic diseases was proved to involve many inflammatory responses, so patients are more likely to benefit from immune regulation therapy. Tocilizumab is a monoclonal antibody that inhibits the binding of interleukin-6 (IL-6), a multifunctional cytokine that regulates the immune response and inflammation, to its receptor (IL-6R). The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.

Study Timeline

• Study Start: 2021-02-22
• Status Verified: 2021-03
• Study First Submitted: 2021-12-19
• Study First Submitted QC: 2021-12-19
• Last Update Submitted: 2021-12-19
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

RP-ILD, previous or concurrent diagnosis of systemic diseases

Exclusion Criteria

pregnancy; uncontrolled pulmonary infections; severe cardiovascular, hepatic and renal dysfunction; unstable angina or myocardial infarction; thrombocytopenia； neutrophil reduction； malignant tumor; allergy to tocilizumab

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocilizumab	Tocilizumab	Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. No Intervention: control, participants in control group will receive regular treatment.

Primary Outcome Measures

Name	Time	Method
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*	3 months	first dose: The tocilizumab group: the tocilizumab administered for the first time; The control group: the maximum dose of glucocorticoid administered for the first time

Secondary Outcome Measures

Name	Time	Method
Length of stay in ICU	3 months
Changes of dyspnea index	3 months
Survival rate after 3 months	3 months
Time to clinical stability	3 months	clinical stability was defined as on the first day that all of the following criteria are simultaneously achieved: (1) Participants can tolerate walking with or without oxygen therapy; (2) no wheeze; and (3) oxygen saturation \>88% on room air.
Length of stay in hospital	3 months
The occurrence of adverse events within 1, 3, 7, 14, 28 days and 3 months after the first dose	3 months	adverse events: sepsis, treatment-related hyperglycemia, gastrointestinal bleeding, hospital infection
Changes of erythrocyte sedimentation rate, c-reactive protein or ferritin at baseline and on day 3, 7, 14, 28, month 3 after the first dose	3 months
Computed tomography score	3 months
Hospitalization cost	3 months
Re-admission rate	3 months

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China