Adults 18 to 65, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR)Primary· Baseline, Week 16
sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts
Group
Value
95% CI
Cohort A - CFZ533 600 mg
17
Cohort B - LYS006 20 mg
8
Cohort C - MAS825 300 mg
15
Pooled Placebo (Cohorts A, B and C)
14
Cohort D - LOU064 25 mg
24
Cohort D - LOU064 100 mg
16
Pooled Placebo (Cohorts A, B, C and D)
17
Cohort E - VAY736 300 mg
16
Pooled Placebo (Cohorts A, B, C, D and E)
23
Adverse events — posted to ClinicalTrials.gov
Time frame: Cohorts A, B and C: 28 weeks including 12 weeks follow up period. Cohort D: 20 weeks including 4 weeks follow up period. Cohort E (ongoing): up to 116 weeks including 100 weeks follow up period..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04129528 — Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects
· Phase 2
· completed
NCT03781414 — Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibo
· Phase 2
· terminated
NCT03905525 — Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
· Phase 2
· completed
NCT03656562 — Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
· Phase 2
· completed
NCT03610516 — Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
· Phase 2
· completed
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Currently open trials in the same condition.
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· recruiting
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 4
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 6 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03827798.