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New combo therapy aims to improve lung function in stubborn lung disease

NCT ID NCT02990286

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding rituximab (a drug that calms certain immune cells) to standard mycophenolate mofetil treatment helps people with interstitial lung disease whose lungs are not responding to initial therapy. 122 adults with various ILD types received either rituximab infusions plus MMF or placebo infusions plus MMF. The main goal was to see if lung function (measured by FVC) improved after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab (a drug that targets certain immune cells) given as two intravenous infusions two weeks apart, plus mycophenolate mofetil (an immunosuppressant taken daily).
What this could lead to
If successful, this combination could offer a new treatment option for people with interstitial lung disease whose lungs are not improving with standard therapy.
What could go wrong
This is a completed Phase 3 trial with 122 participants, so results are available but may not apply to all ILD types. Rituximab can cause infusion reactions and increase infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

122 people

The number who actually took part.

Started

Jan 2017

Finished

Feb 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. A diagnosis of ILD: * ILD associated with differentiated CTD or IPAF (based on internationally accepted criteria) * OR idiopathic ILD 3. A diagnosis of NSIP based on: * a histological pattern of NSIP * 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 4. 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. 5. Subjects covered by or having the rights to French social security (including CMU), 6. 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. 7. Ability for subject to comply with the requirements of the study Exclusion Criteria: 1. Known diagnosis of significant respiratory disorders (asthma, tuberculosis, sarcoidosis, aspergillosis, or cystic fibrosis) other than CTD-NSIP, IPAF-NSIP and iNSIP 2. 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. 3. HRCT pattern of typical usual interstitial pneumonia (UIP) 4. For patients with idiopathic ILD, HRCT pattern of possible UIP (no evocative of NSIP) 5. Histological pattern other than pattern of NSIP 6. A first line treatment with MMF or rituximab 7. Known hypersensitivity to MMF or rituximab or sulfonamide antibiotics 8. 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 9. Patients registered on a pulmonary transplantation list 10. Patients with known hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) hereditary deficiency (such as Lesch-Nyhan and Kelley-Seegmiller syndrome) 11. 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. 12. 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 13. Current history of substance and/or alcohol abuse 14. Deprivation of liberty, under judicial protection 15. Participation in another biomedical research with experimental drug or medical device

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AP-HM Hôpital NORD

    Marseille, 13015, France

  • CHRU Tours

    Tours, 37044, France

  • Chu Besancon

    Besançon, 25030, France

  • Chu Dijon

    Dijon, 21079, France

  • Chu Rennes

    Rennes, 35033, France

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