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Step-Up HSNCT05889182

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

StatusActive, Not Recruiting
PhasePhase 3
SponsorAbbVie
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later.

See at-risk trials from AbbVie

Track this trial

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Record History

The 50 most recent of 174 versions: 42 with changes below, 8 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 11 words Show 4 more changesShow less
    • Primary completion pushed from Mar 2028 to Aug 2028
    • Study completion date: Sep 2028 to Aug 2028
    • Secondary endpoints: 9 to 8
    • Study sites revised (285)
  2. Enrollment closed, study ongoing
    • Site details revised at 285 of 285 sites
    v172
  3. Study sites revised (285)v170
  4. Site details revised at 1 of 285 sitesv169
  5. Study sites revised (285)v168
  6. Study completion pushed from Mar 2028 to Sep 2028
    • Site details revised at 139 of 285 sites
    v167
  7. Site details revised at 8 of 285 sitesv166
  8. Study completion date: Mar 2028 to Sep 2028
    • Study sites revised (285)
    v165
  9. Study sites revised (285)v164
  10. Study sites revised (285)v163
  11. Site details revised at 1 of 285 sitesv162
  12. Study sites: 284 to 285v160
  13. Study sites: 283 to 284v159
  14. Study sites: 277 to 283v158
  15. Study sites: 276 to 277v157
  16. Study sites revised (276)v156
  17. Study sites: 275 to 276v155
  18. Study sites revised (275)v154
  19. Study sites: 273 to 275v152
  20. Site details revised at 1 of 273 sitesv151
  21. Study sites: 272 to 273v150
  22. Study sites: 270 to 272v149
  23. Study sites: 269 to 270v148
  24. Study sites: 268 to 269v147
  25. Study sites: 267 to 268v145
  26. Study sites revised (267)v143
  27. Study sites revised (267)v142
  28. Study sites: 266 to 267v141
  29. Site details revised at 1 of 266 sitesv140
  30. Study sites: 265 to 266v139
  31. Study sites: 264 to 265v138
  32. Study sites: 263 to 264v137
  33. Study sites: 262 to 263v136
  34. Study sites: 260 to 262v135
  35. Study sites revised (260)v134
  36. Study sites: 259 to 260v133
  37. Study sites: 258 to 259v132
  38. Primary and study completion dates pushed to Mar 2028v129 Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Primary endpoints: 1 to 2
    • Study sites: 254 to 258
    • Secondary endpoints: 8 to 9
  39. Site details revised at 1 of 254 sitesv128
  40. Study sites: 253 to 254v127
  41. Study sites: 252 to 253v126
  42. Study sites: 250 to 252v125
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
Timeframe: Baseline to Week 16
Number of Participants with Adverse Events (AEs)
Timeframe: Up to Approximately Week 108

Secondary (8)

Change from Baseline in Draining Fistula Count
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline
Percentage of Participants Achieving NRS3 at Week 4 Among Participants with NRS ≥ 3 at Baseline
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
Show 3 moreShow less
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥16 Years Old and Older
Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1

Arms and interventions

Period 1: Upadacitinib Dose AExperimental

Participants will receive Upadicitinib Dose A once daily for 16 weeks.

Period 1: PlaceboPlacebo comparator

Participants will receive Placebo once daily for 16 weeks.

Period 2: Group 1 - Upadacitinib Dose AExperimental

Participants who were randomized to placebo in Period 1 who did not achieve HiSCR 50 (clinical non-responder, CNR) at Week 16 will receive Upadacitinib Dose A once daily for 20 weeks.

Period 2: Group 2 - PlaceboPlacebo comparator

Participants who were randomized to placebo in Period 1 who achieve HiSCR 50 (clinical responder, CR) at Week 16 will continue to receive placebo once daily for 20 weeks.

Period 2: Group 3 - Upadacitinib Dose AExperimental

Participants who were randomized to upadacitinib Dose A in Period 1 who did not achieve HiSCR 50 (CNR) at Week 16 will continue to receive upadacitinib Dose A once daily for 20 weeks.

Period 2: Group 4 - Upadacitinib Dose AExperimental

Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose A once daily for 20 weeks.

Period 2: Group 5 - Upadacitinib Dose BExperimental

Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose B once daily for 20 weeks.

Period 2: Group 6 - PlaceboExperimental

Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive placebo once daily for 20 weeks.

Period 3: Long-Term ExtensionExperimental

Eligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.

Drugs: Upadacitinib, Placebo

Sites

285 sites in 37 countries

United States 87, Canada 20, Germany 15, Japan 10, Hungary 9, Italy 9, Spain 8, Argentina 7, Belgium 7, Brazil 7, Croatia 7, United Kingdom 7, France 6, Turkey (Türkiye) 6, Australia 5, Greece 5, Ireland 5, Israel 5, Slovakia 5, South Korea 5, Bulgaria 4, Chile 4, Colombia 4, Portugal 4, Saudi Arabia 4, Taiwan 4, Austria 3, Czechia 3, Mexico 3, Switzerland 3, Finland 2, Lithuania 2, Netherlands 2, New Zealand 2, Puerto Rico 2, Singapore 2, Sweden 2