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NCT07007962: LUNA 4
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Phase 3 trial testing rilzabrutinib in Immune Thrombocytopenia in 60 participants. Currently enrolling.
5 November 2027
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 24 October 2025 |
| Primary completion | 5 November 2027 |
| Estimated completion | 30 December 2028 |
| Sites | 20 locations across Italy, France, Austria, Hungary, Poland, United States, Spain |
Drugs / interventions tested
- rilzabrutinib (RILZABRUTINIB) — full drug profile →
Conditions studied
- Immune Thrombocytopenia — all drugs for Immune Thrombocytopenia →
Sponsor
Sanofi — full company profile →
Who can join
18 and older, any sex, with Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Translational immunothrombosis in autoimmune Heparin-Induced thrombocytopenia: targeting the FcγRIIa-Syk-BTK and complement pathways.
Ahmadinia M, Askarzade A, Afsharara H, Gholizadeh Niari B, et al · · 2026 · PMID 41689663 · DOI 10.1007/s10238-026-02048-z
Verify or expand the search:
- PubMed search for NCT07007962
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of rilzabrutinib
Trials testing the same drug.
- NCT07216079 — Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan · Phase 3 · active not recruiting
- NCT07086976 — A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Partici · Phase 3 · recruiting
- NCT06500702 — A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Ye · Phase 2 · recruiting
- NCT05002777 — Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) · Phase 2 · active not recruiting
- NCT05107115 — Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H · Phase 2 · completed
Other recruiting trials for Immune Thrombocytopenia
Currently open trials in the same condition.
- NCT07104565 — Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Diso · Phase 2 · recruiting
- NCT07216079 — Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan · Phase 3 · active not recruiting
- NCT06776510 — A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia · Phase 1, PHASE2 · recruiting
- NCT06715215 — Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia · NA · recruiting
- NCT06727669 — Longitudinal Cohort of Thrombosis and Hemostasis Diseases · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07007962 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07007962.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing