New combo therapy aims to improve lung function in stubborn lung disease
NCT ID NCT02990286
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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122 people
The number who actually took part.
- Started
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Jan 2017
- Finished
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Feb 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AP-HM Hôpital NORD
Marseille, 13015, France
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CHRU Tours
Tours, 37044, France
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Chu Besancon
Besançon, 25030, France
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Chu Dijon
Dijon, 21079, France
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Chu Rennes
Rennes, 35033, France
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