Should sarcoidosis patients stay on infliximab? new trial aims to find out
NCT ID NCT05689879
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial looks at whether people with severe sarcoidosis who are in remission should stop or continue taking infliximab. 32 adults who have been on infliximab for at least 6 months and are stable on low-dose steroids will be randomly assigned to stop or continue the drug. The goal is to see which strategy better prevents major relapses over the next year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- infliximab (a TNF-alpha inhibitor)
- What this could lead to
- If successful, this could show that continuing infliximab longer helps prevent relapses in people with severe sarcoidosis.
- What could go wrong
- This is a small, early-stage trial with only 32 participants, so results may not apply to everyone. There is also a risk of side effects from continued infliximab use.
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
-
32 people
The number who actually took part.
- Started
-
Mar 2023
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- 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 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: * Age superior or equal to 18 years * Clinical and radiological presentation consistent with sarcoidosis * Presence of non-caseating granulomas in at least one organ * Exclusion or other causes of granulomas * Infliximab treatment for at least 6 months * Steroid dosage \< or equal to 10 mg/day for at least 6 months * No activity of the disease (ePOST score 0) for at least 6 months * Normal ACE (angiotensin converting enzyme) and serum calcemia level * Signed informed consent * Affiliated to the National French social security system * As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity. Exclusion Criteria: * Pregnancy or breast-feeding * Positive IGRA (Interferon Gamma Release Assays) test without previous antituberculous antibiotherapy * Active infection * Patients with moderate to severe heart failure (NYHA class III/ IV) * Severe liver function disorders * Alcoholism * Severe kidney function disorders * Pre-existing blood dyscrasias * History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers) * Concurrent vaccination with live vaccines during therapy * Inability to understand information about protocol * Adult subject under legal protection or unable ton consent * Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation * Concomitant participation to another biomedical research (only Category 1 trial according to the french law)
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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
-
Hôpital de la Pitié-Salpêtrière
Paris, 75013, France
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