Clinical trial NCT06840392: 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: 2025-02-21
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: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center PC
state: Alabama
city: Gilbert
country: United States
facility: CTT Research
state: Arizona
city: Scottsdale
country: United States
facility: Ctr Dermatology and Plastic Surgery
state: Arizona
city: Fremont
country: United States
facility: Ctr for Dermatology Clinical Res
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: Coral Gables
country: United States
facility: Driven Research
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory School of Med Dermatology
state: Georgia
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: New Albany
country: United States
facility: Southern IN Clinical Trials
state: Indiana
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Inst of MI
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: New Hyde Park
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Cameron Dermatology
state: New York
city: Boardman
country: United States
facility: Optima Research Boardman
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Fairborn
country: United States
facility: Wright State University
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center LLC
state: Ohio
city: Charleston
country: United States
facility: Clinical Research Ctr of Carolinas
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology and Skin Care Center
state: Tennessee
city: Humble
country: United States
facility: Accurate Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Inst for Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies-Lee
state: Texas
city: Arlington
country: United States
facility: Care Access Alexandria
state: Virginia
city: Danville
country: United States
facility: Complexions Dermatology
state: Virginia
city: Vienna
country: United States
facility: Forefront Dermatology
state: Virginia
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Ipoh
country: Malaysia
facility: Novartis Investigative Site
state: Perak
city: Kota Kinabalu
country: Malaysia
facility: Novartis Investigative Site
state: Sabah
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: Wilayah Persekutuan
city: Selangor Darul Ehsan
country: Malaysia
facility: Novartis Investigative Site
city: Wilayah Persekutuan
country: Malaysia
facility: Novartis Investigative Site
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: