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A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis

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Trial Profile

A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2025

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At a glance

  • Drugs Rapcabtagene autoleucel (Primary) ; Rituximab
  • Indications Sclerosis
  • Focus Therapeutic Use
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 01 Oct 2025 Planned End Date changed from 13 Oct 2032 to 30 Aug 2032.
  • 01 Oct 2025 Planned primary completion date changed from 15 Dec 2028 to 30 Nov 2028.
  • 13 May 2025 Planned End Date changed from 17 Dec 2030 to 13 Oct 2032.

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