Clinical trial NCT06799000: A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult Patients With Moderate to Severe Hidradenitis Suppurativa
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Bruton's tyrosine kinase (BTK) inhibitor
Hidradenitis Suppurativa
HS
Hidradenitis Suppurativa clinical response
HiSCR
remibrutinib
LOU064
Hidradenitides, Suppurativa
Hidradenitis, Suppurativa
Suppurativa Hidradenitides
Suppurativa Hidradenitis
Acne inversa,
Verneuil disease
Inflammatory skin disease
Chronic skin condition
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks).

Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Eligibility criteria: Key Inclusion Criteria:

1. Male and female participants ≥ 18 years of age at the time of signing of the informed consent.
2. Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
3. Participants with moderate to severe HS defined as:

   * A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND
   * Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)

Key Exclusion Criteria:

1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
2. Any active skin disease or conditions that may interfere with the assessment of HS.
3. Previous exposure to remibrutinib or other BTK inhibitors.
4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
5. Significant bleeding risk or coagulation disorders.
6. History of gastrointestinal bleeding.
7. Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.
8. History or current hepatic disease.
9. Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
10. History of hypersensitivity to any of the study drug constituents.
11. Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.
12. History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.
13. Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of participants with Abscesses and inflammatory nodules 50 (AN50) response at Week 16
timeFrame: Week 16
measure: Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
timeFrame: From baseline up to Week 16
measure: Proportion of participants with HiSCR75 response at Week 16
timeFrame: Week 16
measure: Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16
timeFrame: Up to Week 16
measure: Proportion of participants with HiSCR50 response at Week 8
timeFrame: Week 8
measure: Proportion of participants with HiSCR90 response at Week 16
timeFrame: Week 16
measure: Proportion of participants with clinical response in HS related skin pain (NRS 30), at worst at Week 16
timeFrame: Week 16
measure: Incidence of treatment emergent adverse events and serious adverse events during the study
timeFrame: From randomization to end of study, assessed up to 72 weeks.
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Anaheim
country: United States
facility: Cheryl Effron MD Inc
state: California
city: Sacramento
country: United States
facility: Physioseq
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education LLC
state: Florida
city: Miami
country: United States
facility: University of MiamiHealth System
state: Florida
city: North Miami Beach
country: United States
facility: Ziaderm Research LLC
state: Florida
city: Evans
country: United States
facility: Revival Research Institute LLC
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Rea Group
state: Indiana
city: Clarkston
country: United States
facility: Michigan Center for Rsrch Company
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute
state: Michigan
city: Hoboken
country: United States
facility: Care Access Hoboken
state: New Jersey
city: New York
country: United States
facility: Icahn School Of Med At Mount Sinai
state: New York
city: Rochester
country: United States
facility: Skinsearch of Rochester Inc
state: New York
city: Huntersville
country: United States
facility: OnSite Clinical Solutions LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: UP Medical Center H System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina MUSC
state: South Carolina
city: Nashville
country: United States
facility: Advanced Research Experts
state: Tennessee
city: San Antonio
country: United States
facility: RFSA Dermatology
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
state: Rosario
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Phillip
country: Australia
facility: Novartis Investigative Site
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Surrey
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Muar
country: Malaysia
facility: Novartis Investigative Site
state: Johor
city: Kota Bharu
country: Malaysia
facility: Novartis Investigative Site
state: Kelantan
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kuala Terengganu
country: Malaysia
facility: Novartis Investigative Site
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Pulau Pinang
country: Malaysia
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: