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A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

Trial Profile

A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 14 May 2025

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At a glance

  • Drugs Bempikibart (Primary)
  • Indications Alopecia areata
  • Focus Proof of concept; Therapeutic Use
  • Acronyms SIGNAL-AA
  • Sponsors Q32 Bio

Most Recent Events

  • 08 May 2025 According to a Q32 Bio media release, topline data readout on-track for the first half of 2026.
  • 30 Apr 2025 According to a Q32 Bio media release, company announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to Q32 Bios bempikibart (ADX-914) for the treatment of Alopecia Areata.
  • 20 Apr 2025 Planned number of patients changed from 44 to 75.

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