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A Phase 3 registrational trial in patients with Primary Sclerosing Cholangitis

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Trial Profile

A Phase 3 registrational trial in patients with Primary Sclerosing Cholangitis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 Dec 2025

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At a glance

  • Drugs Nebokitug (Primary)
  • Indications Primary sclerosing cholangitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Chemomab Therapeutics

Most Recent Events

  • 20 Nov 2025 According to a Chemomab Therapeutics media release, company continuing productive discussions with the FDA and EMA, and report that we have support from both agencies that a single Phase 3 registration trial would be sufficient for approval. In view of the general alignment of the two regulatory agencies and the advanced status of the Phase 3 design, we expect to launch the trial as soon as feasible.
  • 30 Jun 2025 According to a Chemomab Therapeutics media release, rececent findings from this Phase 2 SPRING trial suggest that nebokitug may have disease-modifying potential in PSC and support advancement to a Phase 3 registration trial.
  • 11 Jun 2025 According to a Chemomab Therapeutics media release, the FDA agreed that this toxicology testing may be conducted in parallel with the nebokitug Phase 3 clinical trial and be submitted as part of the planned Biologics Licensing Application (BLA) and preparations for the Nebokitug PSC Phase 3 Clinical Trial Advance as Discussions with Potential Strategic Partners Continue.

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