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 (RECHARGE 1)
Led by Novartis Pharmaceuticals · Updated on 2026-03-12
555
Participants Needed
145
Research Sites
154 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 (RECHARGE 1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 12 years or older
- Diagnosis of hidradenitis suppurativa for at least 6 months before baseline
- Moderate to severe hidradenitis suppurativa with at least 5 abscesses and/or inflammatory nodules
- Inflammatory lesions affecting at least 2 different body areas
You will not qualify if you...
- More than 20 fistulae or tunnels at baseline
- Any active skin disease that may affect hidradenitis suppurativa assessment
- Previous use of remibrutinib or other BTK inhibitors
- Use of other investigational drugs within 5 half-lives or 30 days before randomization
- Significant bleeding risks or blood clotting disorders
- History of gastrointestinal bleeding
- Need for anti-platelet or anti-coagulant drugs except certain low-dose medications
- History or current liver disease
- Serious cardiovascular, neurological, psychiatric, lung, kidney, liver, endocrine, metabolic, blood, gastrointestinal, or immune disorders that affect safety or study participation
- Known allergy to study drug ingredients
- Active, chronic, or recurring infections including HIV or certain opportunistic infections
- Live vaccine within 6 weeks before randomization or planned during study
- Major surgery within 8 weeks before screening or planned during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 145 locations
1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Actively Recruiting
3
Arkansas Research Trials
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
4
Cheryl Effron MD Inc
Anaheim, California, United States, 92807
Actively Recruiting
5
Physioseq
Sacramento, California, United States, 95826
Actively Recruiting
6
Olive View UCLA Medical Center
Sylmar, California, United States, 91342
Actively Recruiting
7
Clinical Trials Research Institute
Thousand Oaks, California, United States, 91320
Actively Recruiting
8
Howard University College of Medicine
Washington D.C., District of Columbia, United States, 20060
Actively Recruiting
9
Florida Academic Centers Research and Education LLC
Coral Gables, Florida, United States, 33134
Actively Recruiting
10
University of MiamiHealth System
Miami, Florida, United States, 33125
Actively Recruiting
11
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Actively Recruiting
12
Revival Research Institute LLC
Evans, Georgia, United States, 30809
Actively Recruiting
13
Gwinnett Clinical Research Center
Snellville, Georgia, United States, 30078
Actively Recruiting
14
Immunology-Rheumatology Research
Suwanee, Georgia, United States, 30024
Actively Recruiting
15
Illinois Dermatology Institute
Chicago, Illinois, United States, 60602
Actively Recruiting
16
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States, 46256
Actively Recruiting
17
Equity Medical LLC
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
18
Dermat. and Adv. Aesthetics
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
19
Michigan Center for Rsrch Company
Clarkston, Michigan, United States, 48346
Actively Recruiting
20
Henry Ford Hospital
Detroit, Michigan, United States, 48202-2689
Actively Recruiting
21
Revival Research Institute
Troy, Michigan, United States, 48084
Actively Recruiting
22
University of Mississippi Med Ctr
Jackson, Mississippi, United States, 39216
Actively Recruiting
23
Care Access Hoboken
Hoboken, New Jersey, United States, 07030
Actively Recruiting
24
Forest Hills Dermatology Group
New York, New York, United States, 10003
Actively Recruiting
25
Icahn School Of Med At Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
26
Skinsearch of Rochester Inc
Rochester, New York, United States, 14623
Actively Recruiting
27
OnSite Clinical Solutions LLC
Huntersville, North Carolina, United States, 28078
Actively Recruiting
28
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104
Actively Recruiting
29
Unity Clinical Research
Oklahoma City, Oklahoma, United States, 73118
Actively Recruiting
30
Essential Medical Research
Tulsa, Oklahoma, United States, 74137
Actively Recruiting
31
UP Medical Center H System
Pittsburgh, Pennsylvania, United States, 15213-3403
Actively Recruiting
32
Medical University of South Carolina MUSC
Charleston, South Carolina, United States, 29425
Actively Recruiting
33
Advanced Research Experts
Nashville, Tennessee, United States, 37211
Actively Recruiting
34
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
Actively Recruiting
35
RFSA Dermatology
San Antonio, Texas, United States, 78213
Actively Recruiting
36
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
Actively Recruiting
37
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1119ACN
Actively Recruiting
38
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425BEA
Actively Recruiting
39
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
40
Novartis Investigative Site
CABA, Argentina, C1428DZF
Actively Recruiting
41
Novartis Investigative Site
Phillip, Australian Capital Territory, Australia, 2606
Actively Recruiting
42
Novartis Investigative Site
Sydney, New South Wales, Australia, 2010
Actively Recruiting
43
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Actively Recruiting
44
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
45
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Actively Recruiting
46
Novartis Investigative Site
Pleven, Bulgaria, 5800
Actively Recruiting
47
Novartis Investigative Site
Sofia, Bulgaria, 1407
Actively Recruiting
48
Novartis Investigative Site
Stara Zagora, Bulgaria, 6000
Actively Recruiting
49
Novartis Investigative Site
Surrey, British Columbia, Canada, V3V 0C6
Actively Recruiting
50
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1E 1V4
Actively Recruiting
51
Novartis Investigative Site
Hamilton, Ontario, Canada, L8L 3C3
Actively Recruiting
52
Novartis Investigative Site
Richmond Hill, Ontario, Canada, L4C 9M7
Actively Recruiting
53
Novartis Investigative Site
Québec, Quebec, Canada, G1W 4R4
Actively Recruiting
54
Novartis Investigative Site
Saint-Jérôme, Quebec, Canada, J7Z 7E2
Actively Recruiting
55
Novartis Investigative Site
Fuzhou, Fujian, China, 350025
Actively Recruiting
56
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
Actively Recruiting
57
Novartis Investigative Site
Wuhan, Hubei, China, 430022
Actively Recruiting
58
Novartis Investigative Site
Changsha, Hunan, China, 410008
Actively Recruiting
59
Novartis Investigative Site
Changchun, Jilin, China, 130021
Active, Not Recruiting
60
Novartis Investigative Site
Shenyang, Liaoning, China, 110011
Actively Recruiting
61
Novartis Investigative Site
Xian, Shanxi, China, 710004
Actively Recruiting
62
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
63
Novartis Investigative Site
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
64
Novartis Investigative Site
Ningbo, Zhejiang, China, 315016
Actively Recruiting
65
Novartis Investigative Site
Beijing, China, 100144
Actively Recruiting
66
Novartis Investigative Site
Jinan, China, 250012
Actively Recruiting
67
Novartis Investigative Site
Barranquilla, Atlántico, Colombia, 080002
Actively Recruiting
68
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 110221
Actively Recruiting
69
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
70
Novartis Investigative Site
Medellín, Colombia, 050034
Actively Recruiting
71
Novartis Investigative Site
Kobenhavn N V, Denmark, 2400
Actively Recruiting
72
Novartis Investigative Site
Roskilde, Denmark, 4000
Actively Recruiting
73
Novartis Investigative Site
Langenau, Baden-Wurttemberg, Germany, 89129
Actively Recruiting
74
Novartis Investigative Site
Darmstadt, Hesse, Germany, 64283
Actively Recruiting
75
Novartis Investigative Site
Stade, Lower Saxony, Germany, 21682
Actively Recruiting
76
Novartis Investigative Site
Dresden, Saxony, Germany, 01307
Actively Recruiting
77
Novartis Investigative Site
Halle, Saxony-Anhalt, Germany, 06108
Actively Recruiting
78
Novartis Investigative Site
Aachen, Germany, 52074
Actively Recruiting
79
Novartis Investigative Site
Berlin, Germany, 10789
Actively Recruiting
80
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
81
Novartis Investigative Site
Bochum, Germany, 44791
Actively Recruiting
82
Novartis Investigative Site
Bonn, Germany, 53105
Actively Recruiting
83
Novartis Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
84
Novartis Investigative Site
Hamburg, Germany, 20095
Actively Recruiting
85
Novartis Investigative Site
Hanover, Germany, 30159
Actively Recruiting
86
Novartis Investigative Site
Kiel, Germany, 24105
Actively Recruiting
87
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
88
Novartis Investigative Site
Memmingen, Germany, 87700
Actively Recruiting
89
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
90
Novartis Investigative Site
Chaïdári, Greece, 124 62
Actively Recruiting
91
Novartis Investigative Site
Heraklion Crete., Greece, 715 00
Actively Recruiting
92
Novartis Investigative Site
Thessaloniki, Greece, 546 43
Actively Recruiting
93
Novartis Investigative Site
Ancona, AN, Italy, 60126
Actively Recruiting
94
Novartis Investigative Site
Brescia, BS, Italy, 25123
Actively Recruiting
95
Novartis Investigative Site
Catania, CT, Italy, 95123
Actively Recruiting
96
Novartis Investigative Site
Cona, FE, Italy, 44124
Actively Recruiting
97
Novartis Investigative Site
Florence, FI, Italy, 50122
Actively Recruiting
98
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
99
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
100
Novartis Investigative Site
Modena, MO, Italy, 41124
Actively Recruiting
101
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
102
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
103
Novartis Investigative Site
Torino, TO, Italy, 10126
Actively Recruiting
104
Novartis Investigative Site
Muar town, Johor, Malaysia, 84000
Actively Recruiting
105
Novartis Investigative Site
Kota Bharu, Kelantan, Malaysia, 15586
Actively Recruiting
106
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia, 10450
Actively Recruiting
107
Novartis Investigative Site
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
108
Novartis Investigative Site
Kuala Terengganu, Terengganu, Malaysia, 20400
Actively Recruiting
109
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
110
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44340
Actively Recruiting
111
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44650
Actively Recruiting
112
Novartis Investigative Site
Cuauhtémoc, Mexico City, Mexico, 06100
Actively Recruiting
113
Novartis Investigative Site
Chihuahua City, Mexico, 31203
Actively Recruiting
114
Novartis Investigative Site
Bydgoszcz, Poland, 85-094
Actively Recruiting
115
Novartis Investigative Site
Gdansk, Poland, 80-214
Actively Recruiting
116
Novartis Investigative Site
Lodz, Poland, 90-436
Actively Recruiting
117
Novartis Investigative Site
Almada, Portugal, 2805-267
Actively Recruiting
118
Novartis Investigative Site
Braga, Portugal, 4710243
Actively Recruiting
119
Novartis Investigative Site
Coimbra, Portugal, 3004-561
Actively Recruiting
120
Novartis Investigative Site
Lisbon, Portugal, 1169-050
Actively Recruiting
121
Novartis Investigative Site
Lisbon, Portugal, 1998-018
Actively Recruiting
122
Novartis Investigative Site
Porto, Portugal, 4099-001
Actively Recruiting
123
Novartis Investigative Site
Bratislava, Slovakia, 811 09
Actively Recruiting
124
Novartis Investigative Site
Bratislava, Slovakia, 813 69
Actively Recruiting
125
Novartis Investigative Site
Prešov, Slovakia, 080 01
Actively Recruiting
126
Novartis Investigative Site
Trnava, Slovakia, 917 02
Actively Recruiting
127
Novartis Investigative Site
Raslouw Centurion, Gauteng, South Africa, 0157
Actively Recruiting
128
Novartis Investigative Site
Soweto, Gauteng, South Africa, 2013
Actively Recruiting
129
Novartis Investigative Site
Cape Town, South Africa, 7505
Actively Recruiting
130
Novartis Investigative Site
Durban, South Africa, 4058
Actively Recruiting
131
Novartis Investigative Site
Cadiz, Andalusia, Spain, 11009
Actively Recruiting
132
Novartis Investigative Site
Badalona, Barcelona, Spain, 08916
Actively Recruiting
133
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
134
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
135
Novartis Investigative Site
Manises, Valencia, Spain, 46940
Actively Recruiting
136
Novartis Investigative Site
Valencia, Valencia, Spain, 46017
Actively Recruiting
137
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
138
Novartis Investigative Site
Madrid, Spain, 28046
Actively Recruiting
139
Novartis Investigative Site
Valencia, Spain, 46014
Actively Recruiting
140
Novartis Investigative Site
Basel, Switzerland, 4031
Actively Recruiting
141
Novartis Investigative Site
Bern, Switzerland, 3010
Actively Recruiting
142
Novartis Investigative Site
Zurich, Switzerland, 8091
Actively Recruiting
143
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
144
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
145
Novartis Investigative Site
Taoyuan, Taiwan, 33305
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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