Lung Disease, InterstitialPhase 3EvER-ILDNCT02990286

Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases

A Phase 3 study testing Rituximab and Mycophenolate Mofetil in people with Lung Disease, Interstitial, run by University Hospital, Tours at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the efficacy on lung function 6 months after one course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one course of placebo and 6 months of MMF treatment in a broad range of patients with Interstitial Lung Diseases (ILD) non-responders to a… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Disease, Interstitial
What is being tested?: Rituximab and Mycophenolate Mofetil
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 5 sitesFrance
Study dates: 20 Jan 2017to 17 Feb 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
A diagnosis of ILD:
ILD associated with differentiated CTD or IPAF (based on internationally accepted criteria)
OR idiopathic ILD
A diagnosis of NSIP based on:
a histological pattern of NSIP

Show all 11Show fewer

OR HRCT findings suggestive of NSIP defined as basal predominant reticular abnormalities with traction bronchiectasis, peri-bronchovascular extension and subpleural sparing, frequently associated with ground-glass attenuation
Patients who did not respond or relapsed or were not able to continue at least one first-line immunosuppressive treatment of ILD: corticosteroids, azathioprine, cyclophosphamide or other immunosuppressants. For the assessment of clinical response, the absence of response was defined as: either a decrease or an increase, but <10% in % predicted FVC.
Subjects covered by or having the rights to French social security (including CMU),
Written informed consent obtained from subject, with a specific check box on the Consent form of the study, understanding the risk for men and women treated with mycophenolate mofetil. And additional written consent from subject on the care and contraception agreement form for women of childbearing potential treated with mycophenolate.
Ability for subject to comply with the requirements of the study

Who cannot join

Known diagnosis of significant respiratory disorders (asthma, tuberculosis, sarcoidosis, aspergillosis, or cystic fibrosis) other than CTD-NSIP, IPAF-NSIP and iNSIP
Evidence of any clinically significant, severe or unstable, acute or chronically progressive cardiac (severe heart failure New York Heart Association Class IV or severe uncontrolled cardiac disease), other medical disease (other than NSIP) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator.
HRCT pattern of typical usual interstitial pneumonia (UIP)
For patients with idiopathic ILD, HRCT pattern of possible UIP (no evocative of NSIP)
Histological pattern other than pattern of NSIP
A first line treatment with MMF or rituximab

Show all 17Show fewer

Known hypersensitivity to MMF or rituximab or sulfonamide antibiotics
Treatment with immunosuppressive treatments other than corticosteroids:
azathioprine, cyclophosphamide, methotrexate, cyclosporine, tacrolimus, leflunomide within 2 weeks (5 half-lives <= 2 weeks) prior to inclusion
intravenous immunoglobulins, hydroxychloroquine or other monoclonal antibody therapies (such as but not limited to etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 6 months (5 half-lives <= 6 months) prior to inclusion
Patients registered on a pulmonary transplantation list
Patients with known hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) hereditary deficiency (such as Lesch-Nyhan and Kelley-Seegmiller syndrome)
Pregnant or breastfeeding women, or women of child-bearing potential not using two reliable contraceptive methods (including female partners of sexually active men treated with mycophenolate) and men not using a contraceptive method (condom), or women and men having a pregnancy project during the year following randomization.
Patients at significant risk for infectious complications: HIV positive, other known immunodeficiency syndromes, untreated tuberculosis, hepatitis B and C or other known viral infection, infection requiring anti-infectious treatment in the preceding 4 weeks
Current history of substance and/or alcohol abuse
Deprivation of liberty, under judicial protection
Participation in another biomedical research with experimental drug or medical device

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

Chu Besancon
Besançon, 25030
Chu Dijon
Dijon, 21079
AP-HM Hôpital NORD
Marseille, 13015
Chu Rennes
Rennes, 35033
CHRU Tours
Tours, 37044

Other trials in France

About this study

Official title: Evaluation of Efficacy and Safety of Rituximab in Association With Mycophenolate Mofetil Versus Mycophenolate Mofetil Alone in Patients With Interstitial Lung Diseases (ILD) Non-responders to a First-line Immunosuppressive Treatment

Conditions: Lung Disease, Interstitial
Being tested: Rituximab, Placebo of Rituximab, Mycophenolate Mofetil
Keywords: Non specific intertitial pneumonia, interstitial pneumonia with autoimmune feature, connective tissue disease, rituximab, Mycophenolate Mofetil, pulmonary fibrosis
Medical subject headings: Lung Diseases, Interstitial, Connective Tissue Diseases, Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RituximabDrug
Rituximab 500mg concentrate for solution for infusion. One course of IV rituximab consisting of a first infusion of 1000 mg (500 ml solution) rituximab (day 1 infusion), and a second infusion of 1000 mg (500 ml solution) rituximab two weeks later (day 15 infusion)
Placebo of RituximabDrug
500 ml of saline (0.9% sodium chloride) for infusion One course of intravenous placebo of rituximab consisting of a first infusion of 500 ml of saline (0.9% sodium chloride) infusion (day 1 infusion), and a second infusion of 500 ml of saline infusion two weeks later (day 15 infusion)
Mycophenolate MofetilDrug
Mycophenolate Mofetil 500mg film-coated tablets
1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months.

Study groups in NCT02990286
Study group	Role	What they receive
Rituximab with Mycophenolate Mofetil	Experimental	Not described Receives: Drug: Rituximab; Drug: Mycophenolate Mofetil
Placebo of rituximab with Mycophenolate Mofetil	Placebo comparator	Not described Receives: Drug: Placebo of Rituximab; Drug: Mycophenolate Mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in FVC in % of predicted
Change in FVC (in % of predicted) since declines in FVC correlates with increased risk of subsequent mortality in ILD patients and FVC is one of the core set of outcomes defined in interstitial lung diseases. Data obtained from the two groups of patients (rituximab and placebo) will be compared to each other. FVC will be performed in each study center in a standardized manner according to the ATS/ERS recommendations and ECCS reference equations
Measured: From baseline to 6 months

Secondary outcomes (16)

Progression Free Survival (PFS).
PFS is defined as the time 1) to the first acute exacerbation, or 2) to an absolute decline of 10 % points in the percentage of the predicted FVC, or 3) to the necessity to withdraw the MMF with/without a new immunosuppressive treatment (except corticoids), or 4) to death or 5) registration to a lung transplantation list. An acute exacerbation is defined by (1) progressive dyspnea over 1 month or less; (2) new pulmonary infiltrates on chest radiography or computed tomography, and (3) the absence of an overt underlying cause of rapid deterioration
Measured: PFS measured at 3, 6 and 12 months
Changes in the quality of life score
The quality of life score as measured by the SF-36 v1.3 questionnaire, version developed and validated in interstitial lung disease (ILD) patients.
Measured: Changes from baseline to 6 months in the quality of life score, and, changes from baseline to 6 months in the visual analogic scales of dyspnea and cough
Changes in the visual analogic scales of dyspnea
Changes in the visual analogic scales of dyspnea (EVA test)
Measured: Changes from baseline to 6 months in the quality of life score, and, changes from baseline to 6 months in the visual analogic scales of dyspnea and cough
Cough evaluation
Changes in cough evaluation
Measured: Changes from baseline to 6 months in cough evaluation
Cumulative doses of corticoids for the 2 groups
Cumulative doses of corticoids for the 2 groups
Measured: Cumulative doses of corticoids at 6 months
Changes in the FVC expressed as % of predicted
Changes in the FVC expressed as % of predicted
Measured: Changes from baseline to 3 and 6 months in the FVC expressed as % of predicted
Changes in DLCO
Changes in DLCO
Measured: Changes from baseline to 6 months in DLCO
Changes in the 6-minutes-walk test
Changes in the 6-minutes-walk test
Measured: Changes from baseline to 6 months in the 6-minutes-walk test
Changes in autoantibodies concentration
Changes in autoantibodies concentration
Measured: Changes from baseline to 6 months in autoantibodies concentration
Changes in biological markers related to lymphocyte B depletion: CD19 lymphocytes
Changes in biological markers related to lymphocyte B depletion: CD19 lymphocytes
Measured: Changes from baseline to 6 months in lymphocytes B CD19
Changes in gammaglobulins
Changes in gammaglobulins
Measured: Changes from baseline to 6 months in gammaglobulins
Changes in HRCT of the chest images
Changes in HRCT of the chest images
Measured: Changes from baseline to 6 months in HRCT of the chest images
Adverse events related to treatment
In particular infectious adverse events and biological blood disorders during the 6 months of study period will be collected
Measured: Adverse events during the 6 months of study period
Rituximab PK parameters : distribution volume
Rituximab PK parameters : distribution volume
Measured: Points at Day1, Day15, 3 and 6 months
Rituximab clearance
Rituximab clearance
Measured: Points at Day1, Day15, 3 and 6 months
Half-life of rituximab in blood
Half-life of rituximab in blood
Measured: Points at Day1, Day15, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 201717 Feb 2020

First posted13 Dec 2016 (estimated)
Study start20 Jan 2017
Primary completion24 Jul 2019
Study completion17 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lung Disease, InterstitialStudies of the same condition, open and under way.
More trials run by University Hospital, ToursThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02990286
Sponsor's protocol ID: PHRN15-SMA/EvER-ILD
Acronym: EvER-ILD
Status last verified: Dec 2025
First submitted: 25 Nov 2016
Last updated: 30 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mankikian J, Caille A, Reynaud-Gaubert M, Agier MS, Bermudez J, Bonniaud P, Borie R, Brillet PY, Cadranel J, Court-Fortune I, Crestani B, Debray MP, Gomez E, Gondouin A, Hirschi-Santelmo S, Israel-Biet D, Jouneau S, Juvin K, Leger J, Kerjouan M, Marquette CH, Naccache JM, Nunes H, Plantier L, Prevot G, Quetant S, Traclet J, Valentin V, Uzunhan Y, Wemeau-Stervinou L, Bejan-Angoulvant T, Cottin V, Marchand-Adam S; EVER-ILD investigators and the OrphaLung network. Rituximab and mycophenolate mofetil combination in patients with interstitial lung disease (EVER-ILD): a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2023 Jun 8;61(6):2202071. doi: 10.1183/13993003.02071-2022. Print 2023 Jun.
PubMed 37230499
Bejan-Angoulvant T, Naccache JM, Caille A, Borie R, Nunes H, Ferreira M, Cadranel J, Crestani B, Cottin V, Marchand-Adam S; OrphaLung. Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial. Respir Med Res. 2020 Nov;78:100770. doi: 10.1016/j.resmer.2020.100770. Epub 2020 May 23.
PubMed 32777737

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Efficacy and Safety of Rituximab in Association With Mycophenolate Mofetil Versus Mycophenolate Mofetil Alone in Patients With Interstitial Lung Diseases (ILD) Non-responders to a First-line Immunosuppressive Treatment
ClinicalTrials.gov ID: NCT02990286
Acronym / sponsor ID: EvER-ILD / PHRN15-SMA/EvER-ILD
Conditions: Lung Disease, Interstitial
Keywords: Non specific intertitial pneumonia, interstitial pneumonia with autoimmune feature, connective tissue disease, rituximab, Mycophenolate Mofetil, pulmonary fibrosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: University Hospital, ToursUniversity, hospital or other
Study start: 20 Jan 2017 (actual)
Primary completion: 24 Jul 2019 (actual)
Study completion: 17 Feb 2020 (actual)
First posted: 13 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Rituximab with Mycophenolate Mofetil	Experimental	Drug: Rituximab, Drug: Mycophenolate Mofetil
Placebo of rituximab with Mycophenolate Mofetil	Placebo comparator	Drug: Placebo of Rituximab, Drug: Mycophenolate Mofetil

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age ≥ 18 years
A diagnosis of ILD:
A diagnosis of NSIP based on:
Patients who did not respond or relapsed or were not able to continue at least one first-line immunosuppressive treatment of ILD: corticosteroids, azathioprine, cyclophosphamide or other immunosuppressants. For the assessment of clinical response, the absence of response was defined as: either a decrease or an increase, but <10% in % predicted FVC.
Subjects covered by or having the rights to French social security (including CMU),

Key exclusion criteria (17 listed)

Known diagnosis of significant respiratory disorders (asthma, tuberculosis, sarcoidosis, aspergillosis, or cystic fibrosis) other than CTD-NSIP, IPAF-NSIP and iNSIP
Evidence of any clinically significant, severe or unstable, acute or chronically progressive cardiac (severe heart failure New York Heart Association Class IV or severe uncontrolled cardiac disease), other medical disease (other than NSIP) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator.
HRCT pattern of typical usual interstitial pneumonia (UIP)
For patients with idiopathic ILD, HRCT pattern of possible UIP (no evocative of NSIP)
Histological pattern other than pattern of NSIP

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RituximabRituximab 500mg concentrate for solution for infusion. One course of IV rituximab consisting of a first infusion of 1000 mg (500 ml solution) rituximab (day 1 infusion), and a second infusion of 1000 mg (500 ml solution) rituximab two weeks later (day 15 infusion)	Drug	Rituximab with Mycophenolate Mofetil
Placebo of Rituximab500 ml of saline (0.9% sodium chloride) for infusion One course of intravenous placebo of rituximab consisting of a first infusion of 500 ml of saline (0.9% sodium chloride) infusion (day 1 infusion), and a second infusion of 500 ml of saline infusion two weeks later (day 15 infusion)	Drug	Placebo of rituximab with Mycophenolate Mofetil
Mycophenolate MofetilMycophenolate Mofetil 500mg film-coated tablets 1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months.	Drug	Placebo of rituximab with Mycophenolate Mofetil, Rituximab with Mycophenolate Mofetil

Primary outcome

Change in FVC in % of predicted
Time frame: From baseline to 6 months
Change in FVC (in % of predicted) since declines in FVC correlates with increased risk of subsequent mortality in ILD patients and FVC is one of the core set of outcomes defined in interstitial lung diseases. Data obtained from the two groups of patients (rituximab and placebo) will be compared to each other. FVC will be performed in each study center in a standardized manner according to the ATS/ERS recommendations and ECCS reference equations

16 secondary outcomes

Progression Free Survival (PFS).
Time frame: PFS measured at 3, 6 and 12 months
Changes in the quality of life score
Time frame: Changes from baseline to 6 months in the quality of life score, and, changes from baseline to 6 months in the visual analogic scales of dyspnea and cough
Changes in the visual analogic scales of dyspnea
Time frame: Changes from baseline to 6 months in the quality of life score, and, changes from baseline to 6 months in the visual analogic scales of dyspnea and cough
Cough evaluation
Time frame: Changes from baseline to 6 months in cough evaluation
Cumulative doses of corticoids for the 2 groups
Time frame: Cumulative doses of corticoids at 6 months
Changes in the FVC expressed as % of predicted
Time frame: Changes from baseline to 3 and 6 months in the FVC expressed as % of predicted
Changes in DLCO
Time frame: Changes from baseline to 6 months in DLCO
Changes in the 6-minutes-walk test
Time frame: Changes from baseline to 6 months in the 6-minutes-walk test
Changes in autoantibodies concentration
Time frame: Changes from baseline to 6 months in autoantibodies concentration
Changes in biological markers related to lymphocyte B depletion: CD19 lymphocytes
Time frame: Changes from baseline to 6 months in lymphocytes B CD19
Changes in gammaglobulins
Time frame: Changes from baseline to 6 months in gammaglobulins
Changes in HRCT of the chest images
Time frame: Changes from baseline to 6 months in HRCT of the chest images
Adverse events related to treatment
Time frame: Adverse events during the 6 months of study period
Rituximab PK parameters : distribution volume
Time frame: Points at Day1, Day15, 3 and 6 months
Rituximab clearance
Time frame: Points at Day1, Day15, 3 and 6 months
Half-life of rituximab in blood
Time frame: Points at Day1, Day15, 3 and 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Results publication: PubMed 37230499Mankikian J, Caille A, Reynaud-Gaubert M, Agier MS, Bermudez J, Bonniaud P, Borie R, Brillet PY, Cadranel J, Court-Fortune I, Crestani B, Debray MP, Gomez E, Gondouin A, Hirschi-Santelmo S, Israel-Biet D, Jouneau S, Juvin K, Leger J, Kerjouan M, Marquette CH, Naccache JM, Nunes H, Plantier L, Prevot G, Quetant S, Traclet J, Valentin V, Uzunhan Y, Wemeau-Stervinou L, Bejan-Angoulvant T, Cottin V, Marchand-Adam S; EVER-ILD investigators and the OrphaLung network. Rituximab and mycophenolate mofetil combination in patients with interstitial lung disease (EVER-ILD): a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2023 Jun 8;61(6):2202071. doi: 10.1183/13993003.02071-2022. Print 2023 Jun.
Derived from this study: PubMed 32777737Bejan-Angoulvant T, Naccache JM, Caille A, Borie R, Nunes H, Ferreira M, Cadranel J, Crestani B, Cottin V, Marchand-Adam S; OrphaLung. Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial. Respir Med Res. 2020 Nov;78:100770. doi: 10.1016/j.resmer.2020.100770. Epub 2020 May 23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

TRACLET Julie principal investigator

HC LYON

NUNES Hilario principal investigator

AP-HP - Hôpital Avicenne

CRESTANI Bruno principal investigator

AP-HP - Hôpital Bichat

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Mycophenolate Mofetil in people with Lung Disease, Interstitial, run by University Hospital, Tours at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FVC in % of predicted (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02990286, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.