NCT05329090: RIGA

Evaluation of Glucocorticoids Plus Rituximab in Patients with Newly-Diagnosed or Relapsing IgA Vasculitis

Active, enrolled Phase 3 Last updated 13 March 2025

What this trial tests

Phase 3 trial testing Rituximab Injection in IgA Vasculitis in 75 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 March 2022

Primary endpoint
16 July 2025

16 January 2026

Quick facts

Lead sponsor	Hopital Foch
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	75
Start date	11 March 2022
Primary completion	16 July 2025
Estimated completion	16 January 2026
Sites	14 locations across France

Drugs / interventions tested

• Rituximab Injection — full drug profile →
• placebo

Conditions studied

• IgA Vasculitis — all drugs for IgA Vasculitis →

Sponsor

Hopital Foch — full company profile →

Who can join

18 and older, any sex, with IgA Vasculitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Systemic vasculitis are inflammatory diseases of the blood vessels, responsible for systemic manifestations. Among the systemic vasculitis affecting small blood vessels, IgA vasculitis (IgAV) is one of the most common forms and mainly affects the skin, joints, kidneys and gastrointestinal tract. Kidney and gastrointestinal damage can be serious, causing complications and life-threatening sequelae, especially in adults. The treatment of adult-onset IgAV is still a matter of debate. Glucocorticoids have been the standard of care for inducing remission for years in severe forms of IgAV. However, not all patients achieve remission and may experience disease flares associated with increased morbidity and mortality. In addition, the cumulative side effects of glucocorticoids are also major causes of long-term adverse events and death.Rituximab (RTX), an anti-CD20 monoclonal antibody, has been shown to be spectacularly effective in inducing remission in d 'other small vascular vessels, in particular ANCA-associated vasculitis and cryoglobulinemic vasculitis, with an acceptable safety profile.

Recently, a multicenter observational study suggested that RTX was an effective and safe therapeutic option for treating relapsed and / or refractory adult IgAV.

Overall, RTX may be an effective and safe therapeutic approach in adult IgAVs, justifying the need for a prospective randomized controlled trial evaluating Rituximab as an induction of remission for adult IgAV.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP).
   Williams CEC, Lamond M, Marro J, Chetwynd AJ, et al · · 2023 · cited 17× · PMID 37755547 · DOI 10.1007/s10067-023-06781-8
2. A case series on recurrent and persisting IgA vasculitis (Henoch Schonlein purpura) in children.
   Marro J, Williams C, Pain CE, Oni L. · · 2023 · cited 11× · PMID 37580746 · DOI 10.1186/s12969-023-00872-1
3. A case series on recurrent and persisting IgA vasculitis (Henoch Schonlein purpura) in children
   Marro J, Williams CE, Pain CE, Oni L. · · 2023 · DOI 10.21203/rs.3.rs-2831178/v1