Actively Recruiting
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Led by Novartis Pharmaceuticals · Updated on 2026-03-11
555
Participants Needed
138
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 12 years of age or older at the time of informed consent
- Diagnosis of hidradenitis suppurativa based on clinical history and physical exam for at least 6 months before baseline
- Moderate to severe hidradenitis suppurativa defined by at least 5 abscesses and/or inflammatory nodules
- Inflammatory lesions affecting at least 2 distinct anatomic areas (e.g., left and right armpits)
You will not qualify if you...
- More than 20 fistulae or tunnels (draining or non-draining) at baseline
- Any active skin disease or condition interfering with hidradenitis suppurativa assessment
- Previous use of remibrutinib or other BTK inhibitors
- Use of other investigational drugs within 5 half-lives, 30 days, or until pharmacodynamics return to baseline prior to randomization
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding
- Need for anti-platelet (except low-dose aspirin or clopidogrel) or anti-coagulant medication
- History or current liver disease
- Major surgery within 8 weeks before screening or planned during the study
- History of hypersensitivity to any study drug components
- Known or suspected active, chronic, or recurrent infectious diseases (e.g., tuberculosis, HIV)
- History of live attenuated vaccine within 6 weeks before randomization or need for such vaccines during treatment
- Any clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, endocrine, metabolic, hematological, gastrointestinal, or immunodeficiency condition that could affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 138 locations
1
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
CTT Research
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Ctr Dermatology and Plastic Surgery
Scottsdale, Arizona, United States, 85260
Actively Recruiting
4
Ctr for Dermatology Clinical Res
Fremont, California, United States, 95438
Actively Recruiting
5
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Actively Recruiting
6
MedDerm Associates
San Diego, California, United States, 92103
Actively Recruiting
7
Driven Research
Coral Gables, Florida, United States, 33134
Actively Recruiting
8
Floridian Research Institute
Miami, Florida, United States, 33179
Actively Recruiting
9
Sarasota Arthritis Res Ctr
Sarasota, Florida, United States, 34239
Actively Recruiting
10
University Of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
11
Emory School of Med Dermatology
Atlanta, Georgia, United States, 30303
Actively Recruiting
12
Atlanta Biomedical Clin Res LLC
Atlanta, Georgia, United States, 30331
Actively Recruiting
13
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
14
Endeavor Health
Glenview, Illinois, United States, 60077
Actively Recruiting
15
Dundee Dermatology
West Dundee, Illinois, United States, 60118
Actively Recruiting
16
Southern IN Clinical Trials
New Albany, Indiana, United States, 47150
Actively Recruiting
17
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
Metro Boston Clinical Partners
Brighton, Massachusetts, United States, 02135
Actively Recruiting
19
Clinical Research Inst of MI
Chesterfield, Michigan, United States, 48047
Actively Recruiting
20
Deluxe Dermatology
St Louis, Missouri, United States, 63117
Actively Recruiting
21
Skin Specialists PC
Omaha, Nebraska, United States, 68144
Actively Recruiting
22
Vivida Dermatology
Las Vegas, Nevada, United States, 89119
Actively Recruiting
23
North Shore University Hospital
New Hyde Park, New York, United States, 11040
Actively Recruiting
24
Cameron Dermatology
New York, New York, United States, 10023
Actively Recruiting
25
Optima Research Boardman
Boardman, Ohio, United States, 44512
Actively Recruiting
26
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
27
Wright State University
Fairborn, Ohio, United States, 45324
Actively Recruiting
28
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
29
Clinical Research Ctr of Carolinas
Charleston, South Carolina, United States, 29407
Actively Recruiting
30
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States, 37072-2301
Actively Recruiting
31
Accurate Clinical Research
Humble, Texas, United States, 77346
Actively Recruiting
32
Austin Inst for Clinical Research
Pflugerville, Texas, United States, 78660
Actively Recruiting
33
Center for Clinical Studies-Lee
Webster, Texas, United States, 77598
Actively Recruiting
34
Care Access Alexandria
Arlington, Virginia, United States, 22206
Actively Recruiting
35
Complexions Dermatology
Danville, Virginia, United States, 24541
Actively Recruiting
36
Forefront Dermatology
Vienna, Virginia, United States, 22182
Actively Recruiting
37
Novartis Investigative Site
Berazategui, Buenos Aires, Argentina, B1837AVT
Actively Recruiting
38
Novartis Investigative Site
CABA, Argentina, C1012AAY
Actively Recruiting
39
Novartis Investigative Site
Caba, Argentina, C1205AAO
Actively Recruiting
40
Novartis Investigative Site
Córdoba, Argentina, B5000
Actively Recruiting
41
Novartis Investigative Site
Linz, Austria, 4020
Actively Recruiting
42
Novartis Investigative Site
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
43
Novartis Investigative Site
Woluwe-Saint-Lambert, Brussels Capital, Belgium, B 1200
Actively Recruiting
44
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
45
Novartis Investigative Site
Liège, Belgium, 4000
Actively Recruiting
46
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1C3
Active, Not Recruiting
47
Novartis Investigative Site
London, Ontario, Canada, N6H 5L5
Actively Recruiting
48
Novartis Investigative Site
Montreal, Quebec, Canada, H1Y 3L1
Actively Recruiting
49
Novartis Investigative Site
Québec, Quebec, Canada, G1V 4T3
Actively Recruiting
50
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1G 1X9
Actively Recruiting
51
Novartis Investigative Site
Medellín, Antioquia, Colombia, 050010
Actively Recruiting
52
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 110221
Actively Recruiting
53
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 111411
Actively Recruiting
54
Novartis Investigative Site
Medellín, Colombia, 050012
Actively Recruiting
55
Novartis Investigative Site
Karlovy Vary, Czechia, 360 01
Actively Recruiting
56
Novartis Investigative Site
Plzen Bolevec, Czechia, 32300
Actively Recruiting
57
Novartis Investigative Site
Prague, Czechia, 100 34
Actively Recruiting
58
Novartis Investigative Site
Prague, Czechia, 128 08
Actively Recruiting
59
Novartis Investigative Site
Prague, Czechia, 150 00
Actively Recruiting
60
Novartis Investigative Site
Prague, Czechia, 150 06
Actively Recruiting
61
Novartis Investigative Site
Prague, Czechia, 180 81
Actively Recruiting
62
Novartis Investigative Site
Brest, France, 29609
Actively Recruiting
63
Novartis Investigative Site
La Rochelle, France, 17019
Actively Recruiting
64
Novartis Investigative Site
Lyon, France, 69003
Actively Recruiting
65
Novartis Investigative Site
Nice, France, 06000
Actively Recruiting
66
Novartis Investigative Site
Reims, France, 51100
Actively Recruiting
67
Novartis Investigative Site
Rouen, France, 76031
Actively Recruiting
68
Novartis Investigative Site
Toulouse, France, 31400
Actively Recruiting
69
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
70
Novartis Investigative Site
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
71
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
72
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
73
Novartis Investigative Site
Merzig, Saarland, Germany, 66663
Actively Recruiting
74
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Actively Recruiting
75
Novartis Investigative Site
Bad Bentheim, Germany, 48455
Actively Recruiting
76
Novartis Investigative Site
Berlin, Germany, 13595
Actively Recruiting
77
Novartis Investigative Site
Dessau, Germany, 06847
Actively Recruiting
78
Novartis Investigative Site
Dortmund, Germany, 44137
Actively Recruiting
79
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
80
Novartis Investigative Site
Hamburg, Germany, 20246
Actively Recruiting
81
Novartis Investigative Site
Lübeck, Germany, 23538
Actively Recruiting
82
Novartis Investigative Site
Minden, Germany, 32429
Actively Recruiting
83
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
84
Novartis Investigative Site
Tübingen, Germany, 72076
Actively Recruiting
85
Novartis Investigative Site
Athens, Greece, 161 21
Actively Recruiting
86
Novartis Investigative Site
Chaïdári, Greece, 124 62
Actively Recruiting
87
Novartis Investigative Site
Thessaloniki, Greece, 564 03
Actively Recruiting
88
Novartis Investigative Site
Pécs, Baranya, Hungary, 7623
Actively Recruiting
89
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
90
Novartis Investigative Site
Debrecen, Hajdú-Bihar, Hungary, 4031
Actively Recruiting
91
Novartis Investigative Site
Budapest, Hungary, 1036
Actively Recruiting
92
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
93
Novartis Investigative Site
Kecskemét, Hungary, 6001
Actively Recruiting
94
Novartis Investigative Site
Szeged, Hungary, 6725
Actively Recruiting
95
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
Actively Recruiting
96
Novartis Investigative Site
Ipoh, Perak, Malaysia, 30450
Actively Recruiting
97
Novartis Investigative Site
Kota Kinabalu, Sabah, Malaysia, 88586
Actively Recruiting
98
Novartis Investigative Site
Johor Bahru, Malaysia, 80100
Actively Recruiting
99
Novartis Investigative Site
Selangor Darul Ehsan, Malaysia, 68100
Actively Recruiting
100
Novartis Investigative Site
Wilayah Persekutuan, Malaysia, 62502
Actively Recruiting
101
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
102
Novartis Investigative Site
Culiacán, Sinaloa, Mexico, 80020
Actively Recruiting
103
Novartis Investigative Site
Durango, Mexico, 34000
Actively Recruiting
104
Novartis Investigative Site
Warsaw, Masovian Voivodeship, Poland, 02-953
Actively Recruiting
105
Novartis Investigative Site
Warsaw, Poland, 02-507
Actively Recruiting
106
Novartis Investigative Site
Warsaw, Poland, 02-962
Actively Recruiting
107
Alma Cruz-Santana Private Practice
Carolina, Puerto Rico, 00985
Actively Recruiting
108
Novartis Investigative Site
Bucharest, District 2, Romania, 020125
Actively Recruiting
109
Novartis Investigative Site
Bucharest, District 2, Romania, 020762
Actively Recruiting
110
Novartis Investigative Site
Bucharest, Romania, 010825
Actively Recruiting
111
Novartis Investigative Site
Timișoara, Romania, 300188
Actively Recruiting
112
Novartis Investigative Site
Granada, Andalusia, Spain, 18014
Actively Recruiting
113
Novartis Investigative Site
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
114
Novartis Investigative Site
Barcelona, Spain, 08041
Actively Recruiting
115
Novartis Investigative Site
Granollers, Spain, 08402
Actively Recruiting
116
Novartis Investigative Site
Las Palmas GC, Spain, 35010
Actively Recruiting
117
Novartis Investigative Site
Madrid, Spain, 28002
Actively Recruiting
118
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
119
Novartis Investigative Site
Pontevedra, Spain, 36003
Actively Recruiting
120
Novartis Investigative Site
Seville, Spain, 41009
Actively Recruiting
121
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
122
Novartis Investigative Site
Izmir, Balcova, Turkey (Türkiye), 35340
Actively Recruiting
123
Novartis Investigative Site
Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800
Actively Recruiting
124
Novartis Investigative Site
Izmir, Buca, Turkey (Türkiye), 35390
Actively Recruiting
125
Novartis Investigative Site
Aydin, Efeler, Turkey (Türkiye), 09100
Actively Recruiting
126
Novartis Investigative Site
Denizli, Kinikli, Turkey (Türkiye), 20070
Actively Recruiting
127
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
Actively Recruiting
128
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Actively Recruiting
129
Novartis Investigative Site
Mersin, Yenisehir, Turkey (Türkiye), 33110
Actively Recruiting
130
Novartis Investigative Site
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
131
Novartis Investigative Site
Kecioren Ankara, Turkey (Türkiye), 06010
Actively Recruiting
132
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Actively Recruiting
133
Novartis Investigative Site
Bristol, United Kingdom, BS1 3NU
Actively Recruiting
134
Novartis Investigative Site
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
135
Novartis Investigative Site
London, United Kingdom, E1 2AT
Actively Recruiting
136
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Actively Recruiting
137
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Actively Recruiting
138
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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