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A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

NCT06840392 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2026-03-11

No results posted yet for this study

Summary

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

Conditions

Interventions

DRUG

Remibrutinib Dose A

Remibrutinib Dose A (oral)

DRUG

Remibrutinib Dose B

Remibrutinib Dose B (oral)

DRUG

Placebo 1

Placebo matching to remibrutinib Dose A (oral)

DRUG

Placebo 2

Placebo matching to remibrutinib Dose B (oral)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2027-10-29
Completion
2028-02-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Malaysia
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840392 on ClinicalTrials.gov