NCT05648968 (VAYHIA) is a Phase 3 clinical trial of Ianalumab in Warm Autoimmune Hemolytic Anemia (wAIHA), sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT05648968?

NCT05648968 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT05648968?

Interventions in NCT05648968: Ianalumab, Placebo.

What condition does NCT05648968 study?

NCT05648968 studies Warm Autoimmune Hemolytic Anemia (wAIHA).

Is NCT05648968 still recruiting?

NCT05648968 is currently active, enrolled. Last updated 19 March 2026.

Last reviewed 2026-03-19 · How we verify

NCT05648968: VAYHIA

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

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

Active, enrolled Phase 3 Last updated 19 March 2026

What this trial tests

Phase 3 trial testing Ianalumab in Warm Autoimmune Hemolytic Anemia (wAIHA) in 90 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 December 2022

Primary endpoint
20 February 2026

19 December 2028

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	30 December 2022
Primary completion	20 February 2026
Estimated completion	19 December 2028
Sites	53 locations across France, Italy, Japan, Malaysia, United Kingdom, Germany, Hungary, Israel

Drugs / interventions tested

Ianalumab — full drug profile →
Placebo

Conditions studied

Warm Autoimmune Hemolytic Anemia (wAIHA) — all drugs for Warm Autoimmune Hemolytic Anemia (wAIHA) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Warm Autoimmune Hemolytic Anemia (wAIHA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.

Publications & conference data

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

Autoimmune Hemolytic Anemias: Challenges in Diagnosis and Therapy.
Barcellini W, Fattizzo B. · · 2024 · cited 10× · PMID 39371250 · DOI 10.1159/000540475
Anti-B-Cell-Activating Factor (BAFF) Therapy: A Novel Addition to Autoimmune Disease Management and Potential for Immunomodulatory Therapy in Warm Autoimmune Hemolytic Anemia.
Cheekati M, Murakhovskaya I. · · 2024 · cited 5× · PMID 39062171 · DOI 10.3390/biomedicines12071597
[The treatment strategies of autoimmune hemolytic anemia].
Yue WR, Wu T, Wang XQ. · · 2024 · cited 1× · PMID 39134500 · DOI 10.3760/cma.j.cn121090-20231027-00236
Antibodies to watch in 2026.
Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669
PB2552: VAYHIA: A RANDOMIZED, DOUBLE-BLIND, PHASE III TRIAL TO ASSESS THE EFFICACY AND SAFETY OF IANALUMAB VS PLACEBO IN PATIENTS WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA THAT FAILED ≥1 LINE OF TREATMENT
Barcellini W, Michel M, Cuker A, Cooper N, et al · · 2023

Verify or expand the search:

Other trials of Ianalumab

Trials testing the same drug.

NCT07039422 — Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (w · Phase 2 · recruiting
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

Other recruiting trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

Currently open trials in the same condition.

NCT05002777 — Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) · Phase 2 · 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 NCT05648968 (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 Novartis Pharmaceuticals
Last refreshed: 19 March 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/NCT05648968.

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