STOP-HS LTE INCB 54707-312

• Research type

  Research Study

• Full title

  Selective Treatment of Oral Povorcitinib in Hidradenitis Suppurativa Long-Term Extension Study (STOP-HS LTE) A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

• IRAS ID

  1009457

• Contact name

  Guillaume BEAUGÉ

• Contact email

  gbeauge@incyte.com

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2023-507204-31

• Clinicaltrials.gov Identifier

  NCT06212999

• Research summary

  The study drug INCB054707 (or povorcitinib) is an investigational drug that is being studied by Incyte Corporation (“Sponsor”) for use in the treatment of Hidradenitis Suppurativa (HS). HS is a skin condition that causes painful lumps under the skin in places like the armpits, groin, and buttocks. This is a Long-Term Extension (LTE) Study for participants with moderate to severe HS who completed the 54-weeks of study treatment in the originating Phase 3 parent studies INCB 54707-301 and INCB 54707-302.
  Approximately 960 participants (18 years and older) from the parent studies will be eligible to participate in this LTE study. The LTE study has two periods: a 52-week double-blind treatment period and a 30-day safety follow-up period.
  Participants will be allocated to one of 3 Cohorts: Cohort A, Cohort B or Cohort C. Allocation to each of the cohorts will be based on how the participant has responded to the treatment in the parent study and on the participants dose during the extension period of the parent study.
  Cohort A: responders who received povorcitinib 75mg daily (QD) during the extension period of the parent study will be re-randomised in a 1:1 ratio to receive povorcitinib 45mg or 75mg QD.
  Cohort B: responders who povorcitinib 45 mg QD during the extension study of the parent study will be re-randomised to receive povorcitinib 45mg QD.
  Cohort C: non-responders from the parent studies or participants originally assigned to Cohort A or B who afterwards have met the loss of response criteria will receive povorcitinib 75 mg QD.
  Cohorts A and B will be double blinded which means the participant and their Study Doctor will not know which dose of povorcitinib the participant is receiving. Cohort C is open label.
  Over the 56 week of this Study (about 13 months), participants will be expected to make about 10 visits to the study site.

• REC name

  Wales REC 5

• REC reference

  24/WA/0062

• Date of REC Opinion

  15 May 2024

• REC opinion

  Further Information Favourable Opinion