Clinical Trials List
Protocol NumberCLOU064J12301
NCT Number(ClinicalTrials.gov Identfier)NCT06799000
Active
2025-03-01 - 2028-09-01
Phase III
Recruiting3
ICD-10L73.2
Hidradenitis suppurativa
ICD-9705.83
Hidradenitis
A randomized, double-blind, double-dummy, placebo-controlled, multicenter phase 3 trial was conducted in adult and adolescent patients with moderate to severe hidradenitis suppurativa to evaluate the efficacy, safety, and tolerability of two doses of remibrutinib for 68 weeks (RECHARGE-1).
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/26
Investigators and Locations
Co-Principal Investigator
- 沈宜萱 無
- TSEN-FANG TSAI 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Hung Lee 無
- 林尚宏 無
- 鄭裕文 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wen-Hung Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
suppurative hidradenitis
Objectives
The aim of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) 10 mg twice daily and 25 mg twice daily compared with placebo in participants with moderate to severe hidradenitis suppurativa (HS).
Test Drug
LOU064
Active Ingredient
LOU064
Dosage Form
Freeze-dried injection
Dosage
10mg, 25mg
Endpoints
The HiSCR50 response was achieved at week 16. The HiSCR50 response was defined as a reduction of at least 50% in the number of abscesses and inflammatory nodules (ANs) compared to the baseline, with no increase in the number of abscesses or fistulas with leakage.
Inclution Criteria
Key Inclusion Criteria:
1. Male and female participants aged ≥ 18 years at the time of inclusion.
2. Diagnosed with hidradenitis suppurativa (HS) based on a clinical history and physical examination at least 6 months prior to the baseline return visit.
3. Participants with moderate to severe hidradenitis suppurativa were defined as:
• A total of at least 5 AN lesions (abscesses and/or inflammatory nodules)
and
• Inflammatory lesions affecting at least 2 distinct anatomical regions (e.g., left and right axillae).
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1. Male and female participants aged ≥ 18 years at the time of inclusion.
2. Diagnosed with hidradenitis suppurativa (HS) based on a clinical history and physical examination at least 6 months prior to the baseline return visit.
3. Participants with moderate to severe hidradenitis suppurativa were defined as:
• A total of at least 5 AN lesions (abscesses and/or inflammatory nodules)
and
• Inflammatory lesions affecting at least 2 distinct anatomical regions (e.g., left and right axillae).
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Exclusion Criteria
Important exclusion criteria:
1. More than 20 fistulas at the baseline (regardless of leakage).
2. Active skin disease or problem that may affect the assessment of hidradenitis suppurativa.
3. Previous use of remibrutinib or other BTK inhibitors.
4. Use of other investigational drugs prior to randomization within 5 half-lives or 30 days (small molecule drugs), or pharmacodynamic effects not yet returned to the baseline (biologics), whichever is longer.
5. Significant bleeding risk or coagulation disorders.
6. History of gastrointestinal bleeding.
7. Requirement for antiplatelet therapy (except for acetylsalicylic acid up to 100 mg daily or clopidogrel up to 75 mg daily) or anticoagulants.
8. Past or current liver disease.
9. Evidence indicates clinically significant cardiovascular disease, neurological disease, mental illness, lung, kidney, liver, endocrine, metabolic, hematological disease, gastrointestinal disease, or immunodeficiency, which the trial administrator deems may impair participant safety, interfere with the interpretation of trial results, or affect participation in the trial or adherence to the trial protocol.
10. History of allergy to any component of the investigational drug.
11. Known or suspected active, chronic, or relapsing infectious disease that, according to the trial administrator's assessment, may preclude participation in the trial. The aforementioned infectious diseases include, but are not limited to, opportunistic infections (e.g., tuberculosis, atypical mycobacterial infections, listeriosis, or aspergillosis) and/or known or suspected human immunodeficiency virus (HIV) infection. HIV testing may be performed to confirm eligibility if required by local regulations and/or deemed appropriate by the trial administrator.
12. Received a live attenuated vaccine within 6 weeks prior to randomization, or is required to receive a live attenuated vaccine during the trial treatment.
13. Underwent major surgery within 8 weeks prior to screening, or have scheduled surgery during the trial.
1. More than 20 fistulas at the baseline (regardless of leakage).
2. Active skin disease or problem that may affect the assessment of hidradenitis suppurativa.
3. Previous use of remibrutinib or other BTK inhibitors.
4. Use of other investigational drugs prior to randomization within 5 half-lives or 30 days (small molecule drugs), or pharmacodynamic effects not yet returned to the baseline (biologics), whichever is longer.
5. Significant bleeding risk or coagulation disorders.
6. History of gastrointestinal bleeding.
7. Requirement for antiplatelet therapy (except for acetylsalicylic acid up to 100 mg daily or clopidogrel up to 75 mg daily) or anticoagulants.
8. Past or current liver disease.
9. Evidence indicates clinically significant cardiovascular disease, neurological disease, mental illness, lung, kidney, liver, endocrine, metabolic, hematological disease, gastrointestinal disease, or immunodeficiency, which the trial administrator deems may impair participant safety, interfere with the interpretation of trial results, or affect participation in the trial or adherence to the trial protocol.
10. History of allergy to any component of the investigational drug.
11. Known or suspected active, chronic, or relapsing infectious disease that, according to the trial administrator's assessment, may preclude participation in the trial. The aforementioned infectious diseases include, but are not limited to, opportunistic infections (e.g., tuberculosis, atypical mycobacterial infections, listeriosis, or aspergillosis) and/or known or suspected human immunodeficiency virus (HIV) infection. HIV testing may be performed to confirm eligibility if required by local regulations and/or deemed appropriate by the trial administrator.
12. Received a live attenuated vaccine within 6 weeks prior to randomization, or is required to receive a live attenuated vaccine during the trial treatment.
13. Underwent major surgery within 8 weeks prior to screening, or have scheduled surgery during the trial.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
555 participants
