New combo therapy aims to tame rare blood vessel disease
NCT ID NCT05329090
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding rituximab to standard steroid treatment helps adults with IgA vasculitis (a disease causing inflamed blood vessels) achieve remission without needing steroids long-term. 75 participants with new or relapsing disease were randomly assigned to receive either rituximab or a placebo, alongside steroids. The goal was to see if more people could stop steroids entirely while staying in remission at 6 and 12 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 depletes certain immune cells) plus glucocorticoids (steroids)
- What this could lead to
- If it works, this could offer a more effective treatment for IgA vasculitis, reducing the need for long-term steroids and their side effects.
- What could go wrong
- This is a relatively small phase 3 trial (75 people), and rituximab may not prove better than steroids alone. It also carries risks like infusion reactions and increased 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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75 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Jan 2026
- 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: * Biopsy-proven diagnosis of IgAV according to Chapel Hill Consensus Conference definitions * Patient aged of 18 years or older * Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined by active manifestations attributable to IgAV * Patients with severe involvement of at least one organ * Patients within the first 21 days following initiation/increase of glucocorticoids at a dose \< 1 mg/kg/day * Has signed an informed consent form prior to any study related procedures * Affiliated to a national health insurance Exclusion Criteria: * Patients with ANCA-associated vasculitis, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, * Patients with IgAV in remission of the disease, * Patients with severe cardiac failure defined as class IV in New York Heart Association, * Patients with severe, uncontrolled cardiac disease, * Patients with acute infections or chronic active infections (including HIV, HBV or HCV), * Patients with active cancer or recent malignancy (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, * Pregnant women and breastfeeding. Patients with childbearing potential must use reliable contraceptive methods throughout the study and at least for 12 months after the last study drug administration, * Patients with IgAV who have already been treated with rituximab within the previous 12 months, * Patients treated with immunosuppressive therapy within the last 3 months, * Patients with hypersensitivity to human or chimeric monoclonal antibodies, * Patients with contraindication to use rituximab, * Patients treated with any concomitant drugs contraindicated for use with the rituximab according to its SmPC, * Patients with contraindication to use routine care treatments (Glucocorticoids, Angiotensin-converting-enzyme (ACEis) or angiotensin receptor blockers (ARBs), dexchlorphéniramine), * Patients in a severely immunocompromised state, * Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric disorders, that could interfere with his/her compliance to protocol requirements, * Patients currently participating in another clinical study or 3 months prior to randomization, * Patients suspected not to be observant to the proposed treatments, * Patients unable to give written informed consent prior to participation in the study * Being deprived of liberty or under guardianship.
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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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APHM de La Timone
Marseille, 13385, France
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CHRU Bretonneau
Tours, 37044, France
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CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
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CHU Clermont Ferrand
Clermont-Ferrand, 63003, France
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CHU Marseille
Marseille, 13005, France
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CHU Nantes
Nantes, 44093, France
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CHU Nîmes (Caremeau)
Nîmes, 30029, France
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CHU Strasbourg
Strasbourg, 67091, France
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CHU Toulouse
Toulouse, 31059, France
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Hopital La Cavale Blanche
Brest, 29200, France
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Hôpital André Grégoire
Montreuil, 93100, France
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Hôpital Cochin
Paris, 75679, France
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Hôpital Edouard Herriot
Lyon, 69003, France
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Hôpital Foch
Suresnes, 92150, France
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