NCT07039422 (VAY RE-HIT) is a Phase 2 clinical trial of Ianalumab in Primary Immune Thrombocytopenia, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT07039422?

NCT07039422 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT07039422?

Interventions in NCT07039422: Ianalumab.

What condition does NCT07039422 study?

NCT07039422 studies Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia.

Is NCT07039422 still recruiting?

NCT07039422 is currently recruiting now. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT07039422: VAY RE-HIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

Recruiting now Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Ianalumab in Primary Immune Thrombocytopenia in 60 participants. Currently enrolling.

Timeline

27 April 2026

Primary endpoint
30 August 2030

30 August 2030

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	27 April 2026
Primary completion	30 August 2030
Estimated completion	30 August 2030
Sites	14 locations across Italy, Malaysia, Belgium, United Kingdom, Germany, Hungary, China, Singapore

Drugs / interventions tested

Ianalumab — full drug profile →

Conditions studied

Primary Immune Thrombocytopenia — all drugs for Primary Immune Thrombocytopenia →
Warm Autoimmune Hemolytic Anemia — all drugs for Warm Autoimmune Hemolytic Anemia →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Primary Immune Thrombocytopenia or Warm Autoimmune Hemolytic Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ianalumab

Trials testing the same drug.

NCT06711887 — Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants · Phase 3 · recruiting
NCT06470048 — A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis · Phase 2 · recruiting
NCT06133972 — Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIR · Phase 3 · recruiting
NCT05885555 — A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Tw · Phase 2 · active not recruiting
NCT05639114 — Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus E · Phase 3 · active not recruiting

Other recruiting trials for Primary Immune Thrombocytopenia

Currently open trials in the same condition.

NCT06531018 — Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia. · Phase 1, PHASE2 · recruiting
NCT06686927 — Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP · Phase 2 · recruiting
NCT06594146 — Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP) · Phase 2 · active not recruiting
NCT06658834 — A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP · Phase 2 · recruiting
NCT05653219 — A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia · Phase 3 · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07039422 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 13 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/NCT07039422.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing