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A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients

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Trial Profile

A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Apr 2026

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At a glance

  • Drugs Soquelitinib (Primary)
  • Indications Autoimmune Lymphoproliferative Syndrome
  • Focus Therapeutic Use

Most Recent Events

  • 20 Mar 2026 Planned primary completion date changed from 1 Mar 2026 to 1 Dec 2026.
  • 12 Mar 2025 According to a Corvus Pharmaceuticals media release, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), whose lead investigator is V. Koneti Rao, MD, FRCPA, Senior Research Physician, Primary Immune Deficiency Clinic (ALPS Clinic) at NIH Clinical Center.
  • 07 Mar 2025 Planned initiation date (estimated date of first participant enrollment) changed from 5 Mar 2025 to 12 Mar 2025.

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