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An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years At the Time of Study Inclusion with Active Moderate to Severe Hidradenitis Suppurativa

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Trial Profile

An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years At the Time of Study Inclusion with Active Moderate to Severe Hidradenitis Suppurativa

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

Latest Information Update: 17 Dec 2025

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At a glance

  • Drugs Sonelokimab (Primary)
  • Indications Hidradenitis suppurativa
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms VELA-TEEN
  • Sponsors MoonLake Immunotherapeutics

Most Recent Events

  • 05 Nov 2025 According to a MoonLake Immunotherapeutics media release, The Company confirmed a Type B meeting with the FDA, which is scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA).
  • 05 Aug 2025 According to a MoonLake Immunotherapeutic media release,Primary endpoint readout from this trial expected in H1 2026.
  • 12 May 2025 Status changed from recruiting to active, no longer recruiting.

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