Phase 2b Study to Evaluate Tulisokibart for Hidradenitis Suppurativa

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderate to Severe Hidradenitis Suppurativa

• IRAS ID

  1011486

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06956235

• Research summary

  Researchers are looking for new ways to treat people with moderate to severe hidradenitis suppurativa (HS). Researchers designed a trial medicine called tulisokibart (MK-7240) to treat HS. The main trial goal is to learn how many people who receive tulisokibart have better improvement in HS after joining the trial compared to those who receive placebo. A placebo looks like the trial medicine but has no trial medicine in it.

  About 147 participants with moderate to severe HS will be in the trial. People can take part if they:
  • Are 18 to 75 years old
  • Have had HS symptoms for at least 6 months
  • Have not gotten better after treatment with antibiotics for HS
  • Have not had recent procedures or surgeries for their HS lesions in the last 6 months
  • Do not have certain, other skin conditions

  Participants will receive one or both treatments every 2 or 4 weeks as an injection (shot) under their skin:
  • Tulisokibart, the trial medicine, at different dose levels (amounts)
  • Placebo

  Participants will receive treatment in 2 parts of the trial.
  In Part 1, participants will receive treatment for 4 months. Participants will be assigned by chance to one group:
  • Group 1: High dose level of tulisokibart
  • Group 2: Medium dose level of tulisokibart
  • Group 3: Low dose level of tulisokibart
  • Group 4: Placebo

  In Part 2, participants may receive treatment for up to 2 more years. Participants who received:
  • Tulisokibart in Part 1 will stay on the same dose level of tulisokibart during Part 2
  • Placebo in Part 1 will be assigned by equal chance to receive either the high or medium dose level of tulisokibart in Part 2

  A participant may be in the trial for up to about 2 and a half years.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  25/LO/0248

• Date of REC Opinion

  13 Jun 2025

• REC opinion

  Further Information Favourable Opinion