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Trial · NCT07228390

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
Difference in proportion of responders based on Hidradenitis Suppurativa Clinical Response achieving at least 50% reduction from baseline (Hidradenitis Suppurativa Clinical Response HiSCR50) in patients with HS treated with ritlecitinib versus placebo.
Week 16The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo.
SecondaryProportion of participants achieving HiSCR50 responseat Weeks 1, 2, 4, 6, 8 and Week 12.The difference in proportion of responders based on HiSCR50 response at Weeks 1, 2, 4, 6, 8 and 12 in patients with HS treated with ritlecitinib versus placebo
SecondaryProportion of participants achieving HiSCR75 responseat Weeks 1, 2, 4, 6, 8, 12 and Week 16.The difference in proportion of responders based on HISCR75 response at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib versus placebo
SecondaryProportion of participants achieving HiSCR90 responseat Weeks 1, 2, 4, 6, 8, 12 and Week 16The difference in proportion of responders based on HiSCR90 response at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib versus placebo
SecondaryResponse based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1Week 16The difference in proportion of responders based on a total AN count of 0 or 1 at Week 16 in patients with HS treated with ritlecitinib and placebo
SecondaryResponse based on a total AN count of 0, 1, or 2At week 16The difference in proportion of responders based on a total AN count of 0, 1 or 2 at Week 16 in patients with HS treated with ritlecitinib and placebo.
SecondaryPercent change from Baseline(CFB) in total AN countWeeks 1, 2, 4, 6, 8, 12 and 16.The difference in mean percent CFB in total AN count at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo
SecondaryAbsolute score in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)at Weeks 1, 2, 4, 6, 8, 12 and 16The difference in mean absolute score in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo
SecondaryCFB in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)at Weeks 1, 2, 4, 6, 8, 12 and 16Mean CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo
SecondaryProportion of participants achieving a HS-IGA=0 or 1Weeks 1, 2, 4, 6, 8, 12 and 16The difference in proportion of responders based on HS-IGA=0 or 1 at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo
SecondaryParticipants who experience an HS flare, defined as at least a 25% increase in total AN count with a minimum increase of 2 relative to BaselineWeeks 4, 8, 12 and 16.The difference in proportion of HS flare at Weeks 4, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo
SecondaryCFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD)Weeks 1, 2, 4, 6, 8, 12 and 16
SecondarySkin pain NRS30 (numeric rating scale) response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3Weeks 1, 2, 4, 6, 8, 12, and 16
SecondaryPercent CFB in skin pain NRS, at worst and on average, respectively, in participants with baseline skin pain NRS ≥3Weeks 1, 2, 4, 6, 8, 12, and 16
SecondaryCFB in skin pain NRS, at worst and on average, respectivelyat Weeks 1, 2, 4, 6, 8, 12, and 16
SecondarySkin pain NRS50 response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3.at Weeks 1, 2, 4, 6, 8, 12, and 16
SecondarySkin pain NRS70 response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3at Weeks 1, 2, 4, 6, 8, 12, and 16,
SecondaryIncidence of treatment emergent adverse events (TEAE), adverse events (AE) and serious adverse events (SAE) leading to discontinuationup to 24 Weeks
SecondaryIncidence of clinically significant laboratory abnormalities over timeup to 24 Weeks
SecondaryAbsolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL)at Weeks 1, 2, 4, 6, 8, 12 and 16.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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