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RecruitingNCT05596786EvER-ILD2Updated Jul 24, 2024

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

A Phase 3 interventional study of Rituximab and Placebo in Lung Diseases, sponsored by University Hospital, Tours. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by University Hospital, Tours · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lung Diseases

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03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 126 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients ≥ 18 years old

  2. Who meet at least one of the following criteria for worsening ILD within 24 months:

    1. a relative decline in the FVC of >= 10% of the predicted value
    2. a relative decrease in the FVC of >=5 to 10% of the predicted value AND i) worsening respiratory symptoms OR ii) an increased extent of ILD on high-resolution CT OR iii) a relative decrease in the DLCO of >= 15% of the predicted value.
    3. worsening of respiratory symptoms AND an increased extent of ILD on high-resolution CT

  3. AND presence of an inflammatory component defined by

    1. a previous histological pattern with lymphocyte infiltrations distant from pulmonary fibrosis to suggest an inflammatory component on pulmonary sample (for example: interstitial lymphoid aggregates with germinal centers, diffuse lympho-plasmocytic infiltrations, granulomas, giant cells or centrilobular inflammation...)
    2. OR a previous alveolar lymphocytosis >20% on Bronchoalveolar lavage fluid (BALF)
  4. Subjects covered by the French social security system
  5. Written informed consent obtained from subject
  6. Ability for subject to comply with the requirements of the study

Exclusion criteria

Exclusion Criteria:

  1. Known diagnosis of significant respiratory disorders (asthma, tuberculosis, aspergillosis, cystic fibrosis, idiopathic pulmonary fibrosis (IPF), Connective Tissue Diseases-ILD, sarcoidosis, desquamative interstitial pneumonia, pulmonary hypertension (PAMp > 30mmHg))) or of significant severe heart failure.
  2. Concomitant medical or surgical disease, clinically significant as considered by the investigator, serious or unstable, acute or chronically progressive, or any condition that could affect the safety of the patient, in the opinion of the investigator including cardiomyopathy or heart failure.
  3. Patient who can not walk more than 100 meters at 6-minutes walk test
  4. HRCT profile of typical usual interstitial pneumonia (UIP)
  5. Histological model of typical NSIP or definitive UIP
  6. Initiation of a new therapy or with interruption/modification of therapy dosage within 6 weeks prior to visit 1
  7. Patient who has already received a rituximab-based treatment line
  8. Known hypersensitivity to rituximab, to murine proteins or other excipients or sulfonamide antibiotics.
  9. Treatment with monoclonal antibodies (such as, but not limited to, etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 6 months (if 5 half-lives ≤ 6 months) prior to inclusion.
  10. Patients on a lung transplant list
  11. Pregnant or breastfeeding women, or women of childbearing age not using a reliable method of contraception during the study and for 12 months following the end of the study treatment.
  12. Patients at high risk of infectious complications: Human Immunodeficiency Virus (HIV) positive or other known immunodeficiency syndromes, hepatitis B and C (HBV, HCV), coronavirus disease (within 3 month) or other known viral infection, infection requiring anti-infective treatment within 4 weeks of inclusion.
  13. Patients with incomplete anti-severe acute respiratory syndrome coronavirus 2 vaccine regimen (according to current recommendations) and in this case who has not receive a treatment with therapeutic antibodies anti-SARSCov2 (ex: tixagévimab/cilgavimab)
  14. Patient under judicial protection, deprivation of liberty
  15. Participation in other interventional research with an investigational drug or medical device.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    Rituximab

    Drug: Rituximab

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugRituximab

    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)

  • OtherPlacebo

    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)

06

What researchers measure

Primary outcomes

  1. Forced vital capacity

    The primary outcome is the change in Forced Vital Capacity (FVC) (in mL) from baseline to 6 months.

    Time frame: From baseline to 6 months

Secondary outcomes

  1. Forced vital capacity

    Change from baseline to 6 months in FVC (in % of predicted)

    Time frame: From baseline to 6 months

  2. Progression free survival (PFS)

    Progression free survival (PFS) defined as the time to (first event considered): a first acute exacerbation, or a relative decline in the FVC of ≥ 10% of the predicted value or the need for new immunosuppressive or/and anti-fibrotic therapies (excluding corticosteroids), or inclusion on a lung transplant list, or death.

    Time frame: At 6 months

  3. King's Brief Interstitial Lung Disease (K-BILD) questionnaire

    Changes in the King's Brief Interstitial Lung Disease (K-BILD) questionnaire.15 questions about the impact of lung disease on life.

    Time frame: From baseline to 6 months

  4. L-PF symptom questionnaire

    Changes in "Living Pulmonary fibrosis-symptom" questionnaire.23 questions about the impact of lung disease on life.

    Time frame: From baseline to 6 months

  5. L-PF impact questionnaire

    Changes in "Living Pulmonary fibrosis-impact" questionnaire.21 questions about the impact of lung disease on life.

    Time frame: From baseline to 6 months

  6. Cumulative doses of corticosteroids

    Difference in cumulative doses of corticosteroids

    Time frame: At 6 months

  7. Diffusing capacity for carbon monoxide (DLCO)

    Changes in % of predicted diffusing capacity for carbon monoxide (DLCO)

    Time frame: From baseline to 6 months

  8. 6 minutes walk test

    Changes in the 6-minute walk test

    Time frame: From baseline to 6 months

  9. Accelerometer-assessed physical activity

    Change in accelerometer-assessed physical activity

    Time frame: From baseline to 6 months

  10. Biological analyse on markers related to B-cell depletion

    Changes of biological markers related to B-cell depletion

    Time frame: From baseline to 6 months

  11. Environmental antigens

    Changes of serology by ELISA of 15 environmental antigens.

    Time frame: From baseline to 6 months

  12. High-resolution computed tomography (HRCT) of chest images

    Changes in high-resolution computed tomography (HRCT) of chest images

    Time frame: From baseline to 6 months

  13. Adverse events

    Description of All adverse events, especially serious infectious adverse events, occurring during the six-month treatment period

    Time frame: From baseline to 6 months

  14. Pharmacokinetic parameters of rituximab

    Rituximab clearance

    Time frame: before and 2 hours after the end of each infusions, at 3 and 6 months after the first infusion

  15. Pharmacokinetic parameters of rituximab

    Volume of distribution

    Time frame: Before and 2 hours after the end of each infusions, at 3 and 6 months after the first infusion

  16. Pharmacokinetic parameters of rituximab

    Half life

    Time frame: Before and 2 hours after the end of each infusions, at 3 and 6 months after the first infusion

  17. Severe Acute Respiratory Syndrome COronaVirus 2 (SARS COV 2) antibodies

    Change of SARS COV 2 antibodies

    Time frame: From baseline to 6 months

07

Study locations

1 of 1 sites recruiting
  • Chru Tours
    Tours, France
    • Sylvain MARCHAND-ADAM · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05596786
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Oct 27, 2022
Start date
Jan 16, 2023
Primary completion
Jul 16, 2026 (estimated)
Completion
Jul 16, 2026 (estimated)
Last update
Jul 24, 2024

Study contacts

Sylvain MARCHAND ADAM, PhD
Contact
sylvain.marchand-adam@univ-tours.fr
+33 2 47 47 98 34
Julien LE BONNIEC
study director · University Hospital Center of Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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