Active Not Recruiting PHASE3 INTERVENTIONAL 3-arm NCT05648968

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

A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment

Sponsor: Novartis Pharmaceuticals

Conditions Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions Ianalumab Placebo

Updated 23 times since 2023 Last updated: Mar 5, 2026 Started: Dec 30, 2022 Primary completion: Feb 16, 2026 Completion: Dec 19, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Warm Autoimmune Hemolytic Anemia (wAIHA), this trial is ongoing. The trial is conducted by Novartis Pharmaceuticals and has accumulated 23 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

23 versions recorded

Mar 2026 — Present [monthly]

Active Not Recruiting PHASE3
Feb 2026 — Mar 2026 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE3
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE3
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE3

▶ Show 18 earlier versions

Oct 2025 — Nov 2025 [monthly]

Recruiting PHASE3
Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE3
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE3
May 2025 — Jun 2025 [monthly]

Recruiting PHASE3
Mar 2025 — May 2025 [monthly]

Recruiting PHASE3
Dec 2024 — Mar 2025 [monthly]

Recruiting PHASE3
Nov 2024 — Dec 2024 [monthly]

Recruiting PHASE3
Sep 2024 — Nov 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Apr 2024 — Jul 2024 [monthly]

Recruiting PHASE3
Mar 2024 — Apr 2024 [monthly]

Recruiting PHASE3
Jun 2023 — Mar 2024 [monthly]

Recruiting PHASE3
May 2023 — Jun 2023 [monthly]

Recruiting PHASE3
Apr 2023 — May 2023 [monthly]

Recruiting PHASE3
Feb 2023 — Apr 2023 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jan 2023 — Feb 2023 [monthly]

Not Yet Recruiting PHASE3

First recorded

Dec 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bangkok, Thailand , Barcelona, Spain , Bassano del Grappa, Italy , Birmingham, United Kingdom , CABA, Argentina , Caba, Argentina , Chiang Mai, Thailand , Créteil, France , Dalian, China , Debrecen, Hungary and 38 more locations