Evaluation of Efficacy and Safety of Rituximab in Patients With Progressive Interstitial Lung Disease (ILD) With Inflammatory Component: a Multicentre Double-blind Placebo-controlled Randomized Trial

Sponsor
University Hospital, Tours
Study ID
NCT05596786
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Lung Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    One course of IV rituximab consisting of a first infusion of 1000 mg (500 mL solution) rituximab (day 1), and a second infusion of 1000 mg (500 mL solution) rituximab two weeks later (day 15)
  • Placebo — OTHER
    One course of IV placebo of rituximab consisting of a first infusion of 500 mL of saline (0.9% sodium chloride) infusion (day 1), and a second infusion of 500 mL of saline infusion two weeks later (day 15)

Study Details

The main objective of the EvER-ILD2 study is to evaluate the efficacy on lung function at 6 months of one course rituximab (2 infusions) comparatively to one course of placebo (2 infusions) in a broad range of progressive ILD patients with inflammatory component.

Key Dates

Start date
Jan 16, 2023
Status verified
Jul 2024
Primary completion
Jul 16, 2026
Completion
Jul 16, 2026

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Forced vital capacity [ Time Frame: From baseline to 6 months ]

Central Contacts

Related Studies