Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Dec 11, 2026 to Sep 11, 2026
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 6 of 36 sites
  2. Results first posted: Feb 6, 2026v47
  3. Primary endpoint revised
    • Study description expanded, about 125 words
    • Study sites revised (36)
    v46
  4. Study completion date: Dec 10, 2026 to Dec 11, 2026
    • Site details revised at 2 of 36 sites
    v45
  5. Site details revised at 2 of 36 sitesv44
Show 42 earlier versionsHide 42 earlier versions
  1. Site details revised at 1 of 36 sitesv43
  2. Re-verified, no change to tracked fieldsv42
  3. Primary completion date changed from estimate of Dec 16, 2024 to Dec 4, 2024
    • Study completion date: Nov 23, 2026 to Dec 10, 2026
    • Study sites revised (36)
    v41
  4. Trial status: Recruiting to Active, Not Recruitingv40 Show 4 more changesShow less
    • Enrollment target: estimated 245 to confirmed 248
    • Study sites: 44 to 36
    • Primary completion date: Nov 22, 2024 to Dec 16, 2024
    • Study completion date: Oct 23, 2026 to Nov 23, 2026
  5. Site details revised at 1 of 44 sitesv39
  6. Site details revised at 6 of 44 sitesv38
  7. Primary completion date: Oct 23, 2026 to Nov 22, 2024
    • Primary endpoint revised
    • Study sites revised (44)
    v37
  8. Site details revised at 1 of 44 sitesv36
  9. Site details revised at 1 of 44 sitesv35
  10. Site details revised at 1 of 44 sitesv34
  11. Site details revised at 2 of 44 sitesv33
  12. Site details revised at 2 of 44 sitesv32
  13. Primary and study completion dates: Sep 30, 2026 to Oct 23, 2026v31
  14. Enrollment target: 200 to 245v30 Show 4 more changesShow less
    • Study sites: 43 to 44
    • Primary and study completion dates: Jul 20, 2026 to Sep 30, 2026
    • Interventions: CFZ533 (Drug), LOU064 100mg (Drug), LOU064 25mg (Drug), LYS006 (Drug), MAS825 (Drug), Placebo to CFZ533 (Drug), Placebo to LOU064 (Drug)… to CFZ533 (Drug), LOU064 100mg (Drug), LOU064 25mg (Drug), LYS006 (Drug), MAS825 (Drug), Placebo to CFZ533 (Drug), Placebo to LOU064 (Drug)…
    • Study arms: 9 to 11
  15. Primary and study completion dates: May 19, 2023 to Jul 20, 2026v29
  16. Primary and study completion dates: Aug 18, 2023 to May 19, 2023
    • Site details revised at 2 of 43 sites
    v28
  17. Re-verified, no change to tracked fieldsv27
  18. Site details revised at 1 of 43 sitesv26
  19. Study sites: 40 to 43
    • Primary and study completion dates: Jun 16, 2023 to Aug 18, 2023
    v25
  20. Primary completion date: Aug 22, 2022 to Jun 16, 2023v24
  21. Site details revised at 1 of 40 sitesv23
  22. Study sites: 38 to 40v22
  23. Study sites: 35 to 38v21
  24. Re-verified, no change to tracked fieldsv20
  25. Interventions: CFZ533 (Drug), LYS006 (Drug), MAS825 (Drug), Placebo to CFZ533 (Drug), Placebo to LYS006 (Drug), Placebo to MAS825 (Drug) to CFZ533 (Drug), LOU064 100mg (Drug), LOU064 25mg (Drug), LYS006 (Drug), MAS825 (Drug), Placebo to CFZ533 (Drug), Placebo to LOU064 (Drug)…
    • Site details revised at 2 of 35 sites
    • Study arms: 6 to 9
    v19
  26. Study sites: 34 to 35v18
  27. Study sites: 33 to 34v17
  28. Site details revised at 1 of 33 sitesv16
  29. Re-verified, no change to tracked fieldsv15
  30. Enrollment target: 130 to 200v14
  31. Interventions: CFZ533 (Drug), LYS006 (Drug), Placebo to CFZ533 (Drug), Placebo to LYS006 (Drug) to CFZ533 (Drug), LYS006 (Drug), MAS825 (Drug), Placebo to CFZ533 (Drug), Placebo to LYS006 (Drug), Placebo to MAS825 (Drug)
    • Site details revised at 1 of 33 sites
    • Study arms: 4 to 6
    v13
  32. Study sites: 32 to 33
    • Primary completion date: May 12, 2022 to Aug 22, 2022
    • Study completion date: Jul 15, 2022 to Jun 16, 2023
    v12
  33. Study sites: 30 to 32
    • Primary completion date: Sep 22, 2022 to May 12, 2022
    • Study completion date: Dec 28, 2022 to Jul 15, 2022
    v11
  34. Study sites: 28 to 30v10
  35. Enrollment target: 90 to 130
    • Study sites: 25 to 28
    v9
  36. Primary completion date: Jun 17, 2020 to Sep 22, 2022
    • Study sites: 22 to 25
    • Study completion date: May 17, 2021 to Dec 28, 2022
    v8
  37. Study sites: 10 to 22v7
  38. Study sites: 9 to 10v6
  39. Study sites: 7 to 9
    • Study completion date: May 10, 2021 to May 17, 2021
    v5
  40. Study sites: 3 to 7v4
  41. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Study completion date: Apr 28, 2021 to May 10, 2021
    • Start date changed from estimate of Feb 14, 2019 to Feb 27, 2019
    v3
  42. Study completion date: May 4, 2021 to Apr 28, 2021
    • Start date: Feb 20, 2019 to Feb 14, 2019
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
Trial Details
NCT Number NCT03827798
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Hidradenitis Suppurativa
Related terms Hidradenitis Suppurativa
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov