Actively Recruiting
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
Led by Immunovant Sciences GmbH · Updated on 2026-05-08
180
Participants Needed
121
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
CONDITIONS
Official Title
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary Sjogren's disease for at least 12 months before screening
- Meet 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjogren's syndrome at screening
- Moderate to severe systemic disease activity with clinESSDAI score of 5 or higher at screening
- Seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at screening
- Residual salivary flow with stimulated whole salivary flow rate of 0.01 mL/min or higher at screening
You will not qualify if you...
- Diagnosis of secondary Sjogren's disease
- Untreated or inadequately treated fibromyalgia
- Other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune diseases that may interfere with assessment
- History of clinically significant monoclonal gammopathy or related conditions
- Active cancer or history of cancer within 5 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 121 locations
1
Site Number - 1027
Covina, California, United States, 91722
Actively Recruiting
2
Site Number - 1007
El Cajon, California, United States, 91910
Actively Recruiting
3
Site Number - 1016
Menifee, California, United States, 92586
Actively Recruiting
4
Site Number - 1029
Thousand Oaks, California, United States, 91360
Actively Recruiting
5
Site Number - 1026
Upland, California, United States, 91786
Actively Recruiting
6
Site Number - 1014
Fort Collins, Colorado, United States, 80528
Actively Recruiting
7
Site Number - 1018
Hollywood, Florida, United States, 33024
Actively Recruiting
8
Site Number - 1021
Jupiter, Florida, United States, 33458
Actively Recruiting
9
Site Number - 1002
Miami, Florida, United States, 33143
Actively Recruiting
10
Site Number - 1004
Tamarac, Florida, United States, 33321
Actively Recruiting
11
Site Number - 1025
Tampa, Florida, United States, 33606
Actively Recruiting
12
Site Number - 1012
Chicago, Illinois, United States, 60607
Actively Recruiting
13
Site Number - 1033
Orland Park, Illinois, United States, 60467
Actively Recruiting
14
Site Number - 1030
Lake Charles, Louisiana, United States, 77469
Actively Recruiting
15
Site Number - 1028
New Orleans, Louisiana, United States, 70112
Actively Recruiting
16
Site Number - 1032
Canton, New York, United States, 13675
Actively Recruiting
17
Site Number - 1006
Mineola, New York, United States, 11501
Actively Recruiting
18
Site Number - 1013
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Site Number - 1015
Jackson, Tennessee, United States, 38305
Actively Recruiting
20
Site Number - 1000
Memphis, Tennessee, United States, 38119
Actively Recruiting
21
Site Number - 1001
Allen, Texas, United States, 75013
Actively Recruiting
22
Site Number - 1020
Amarillo, Texas, United States, 79124
Actively Recruiting
23
Site Number - 1022
Arlington, Texas, United States, 75231
Actively Recruiting
24
Site Number - 1019
Austin, Texas, United States, 78745
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25
Site Number - 1024
Grapevine, Texas, United States, 76034
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26
Site Number - 1011
Houston, Texas, United States, 77030
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27
Site Number - 1010
Houston, Texas, United States, 77407
Actively Recruiting
28
Site Number - 1023
Katy, Texas, United States, 77494
Actively Recruiting
29
Site Number - 1031
San Antonio, Texas, United States, 78215
Actively Recruiting
30
Site number - 5005
Azcuénaga, Buenos Aires, Argentina, C1128AAF
Actively Recruiting
31
Site Number - 5007
Capital Federal, Buenos Aires, Argentina, C1055AAF
Actively Recruiting
32
Site Number - 5008
San Isidro, Buenos Aires, Argentina, B1643CRO
Not Yet Recruiting
33
Site Number - 5004
San Miguel de Tucumán, Tucumán Province, Argentina, T4000
Actively Recruiting
34
Site Number - 5000
Buenos Aires, Argentina, B1646GHP
Actively Recruiting
35
Site Number - 5002
Buenos Aires, Argentina, B1878DVB
Not Yet Recruiting
36
Site Number - 5003
Buenos Aires, Argentina, C1111AAJ
Actively Recruiting
37
Site Number - 5001
Buenos Aires, Argentina, C1417EYH
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38
Site number - 5006
Buenos Aires, Argentina, C1427CCL
Actively Recruiting
39
Site Number - 5506
Vitória, Espírito Santo, Brazil, 01409-900
Not Yet Recruiting
40
Site Number - 5504
Salvador, Estado de Bahia, Brazil, 40150-150
Not Yet Recruiting
41
Site Number - 5500
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Not Yet Recruiting
42
Site Number - 5501
Curitiba, Paraná, Brazil, 80030-110
Not Yet Recruiting
43
Site Number - 5503
Porto Alegre, Rio Gtande Do Sul, Brazil, 90480-003
Not Yet Recruiting
44
Site Number - 5505
Porto Alegre, Rio Gtande Do Sul, Brazil, 90560-030
Not Yet Recruiting
45
Site Number - 2001
Sherbrooke, Quebec, Canada, J1L 0H8
Actively Recruiting
46
Site Number - 2000
Trois-Rivières, Quebec, Canada, G8Z 1Y2
Actively Recruiting
47
Site Number - 5700
Santiago, Santiago de Chile, Chile, 7500571
Not Yet Recruiting
48
Site Number - 5702
Santiago, Santiago de Chile, Chile, 7500571
Not Yet Recruiting
49
Site Number - 5703
Santiago, Santiago de Chile, Chile, 7500587
Not Yet Recruiting
50
Site Number - 5701
Santiago, Santiago de Chile, Chile, 7510047
Not Yet Recruiting
51
Site Number - 5704
Santiago, Santiago de Chile, Chile, 8331143
Not Yet Recruiting
52
Site Number - 5706
Viña del Mar, Valparaiso, Chile, 2520000
Not Yet Recruiting
53
Site Number - 5705
Osorno, Chile, 8380456
Not Yet Recruiting
54
Site Number - 5707
Valdivia, Chile, 5110683
Not Yet Recruiting
55
Site Number - 5800
Medellín, Antioquia, Colombia, 050034
Not Yet Recruiting
56
Site Number - 5804
Barranquilla, Atlántico, Colombia, 080002
Not Yet Recruiting
57
Site Number - 5803
Bogotá, Cundinamarca, Colombia, 110221
Not Yet Recruiting
58
Site Number - 5802
Chía, Cundinamarca, Colombia, 250008
Not Yet Recruiting
59
Site Number - 5801
Bucaramanga, Santander Department, Colombia, 680006
Not Yet Recruiting
60
Site Number - 6504
Bad Doberan, Germany, 18209
Actively Recruiting
61
Site Number - 6506
Cologne, Germany, 50937
Not Yet Recruiting
62
Site Number - 6500
Hamburg, Germany, 20095
Actively Recruiting
63
Site Number - 6501
Hanover, Germany, 30625
Actively Recruiting
64
Site Number - 6503
Heidelberg, Germany, 69120
Actively Recruiting
65
Site number - 6502
Munich, Germany, 80336
Actively Recruiting
66
Site Number - 6505
Munich, Germany, 81667
Actively Recruiting
67
Site Number - 3901
Athens, Greece, 11521
Actively Recruiting
68
Site Number - 3900
Athens, Greece, 11527
Actively Recruiting
69
Site Number - 7550
Budapest, Hungary, 1027
Actively Recruiting
70
Site Number - 7552
Hódmezővásárhely, Hungary, 6800
Actively Recruiting
71
Site Number - 7551
Kalocsa, Hungary, 6300
Actively Recruiting
72
Site Number - 7553
Székesfehérvár, Hungary, 8000
Actively Recruiting
73
Site Number - 6000
Catania, Italy, 95121
Actively Recruiting
74
Site Number - 6001
Milan, Italy, 20132
Not Yet Recruiting
75
Site Number - 6006
Naples, Italy, 80131
Not Yet Recruiting
76
Site Number - 6002
Palermo, Italy, 90129
Actively Recruiting
77
Site Number - 6005
Perugia, Italy, 06132
Not Yet Recruiting
78
Site Number - 6003
Rome, Italy, 00128
Actively Recruiting
79
Site Number - 6007
Salerno, Italy, 84131
Withdrawn
80
Site Number - 2602
Guadalajara, Jalisco, Mexico, 44931
Not Yet Recruiting
81
Site Number - 2604
Cuautitlán Izcalli, State of Mexico, Mexico, 54750
Not Yet Recruiting
82
Site Number - 2605
Toluca, State of Mexico, Mexico, 50090
Not Yet Recruiting
83
Site Number - 2607
Mérida, Yucatán, Mexico, 97070
Not Yet Recruiting
84
Site Number - 2601
Chihuahua City, Mexico, 31020
Not Yet Recruiting
85
Site Number - 2600
Mexico City, Mexico, 06700
Not Yet Recruiting
86
Site Number - 2606
Mexico City, Mexico, 07369
Not Yet Recruiting
87
Site Number - 2603
Mexico City, Mexico, 07760
Not Yet Recruiting
88
Site Number - 2400
Cayma, Arequipa, Peru, 04017
Withdrawn
89
Site Number - 2401
Santiago de Surco, Lima region, Peru, 15023
Not Yet Recruiting
90
Site Number - 2403
Lima, Peru, 15076
Not Yet Recruiting
91
Site Number - 2402
Lima, Peru, 15811
Not Yet Recruiting
92
Site Number - 3008
Bydgoszcz, Poland, 85-065
Actively Recruiting
93
Site Number - 3010
Krakow, Poland, 30-363
Actively Recruiting
94
Site Number - 3014
Lodz, Poland, 31-426
Actively Recruiting
95
Site Number - 3004
Lodz, Poland, 91-363
Actively Recruiting
96
Site Number - 3015
Lublin, Poland, 20-412
Actively Recruiting
97
Site Number - 3005
Lublin, Poland, 20-607
Actively Recruiting
98
Site Number - 3007
Poznan, Poland, 60-693
Actively Recruiting
99
Site Number - 3000
Poznan, Poland, 61-397
Actively Recruiting
100
Site Number - 3011
Siedlce, Poland, 08-110
Actively Recruiting
101
Site Number - 3006
Warsaw, Poland, 00-874
Actively Recruiting
102
Site Number - 3001
Warsaw, Poland, 02-637
Actively Recruiting
103
Site Number - 3003
Warsaw, Poland, 02-665
Actively Recruiting
104
Site Number - 3009
Warsaw, Poland, 02-677
Actively Recruiting
105
Site Number - 3012
Wołomin, Poland, 05-200
Actively Recruiting
106
Site Number - 3002
Wroclaw, Poland, 50-556
Actively Recruiting
107
Site Number - 3013
Wroclaw, Poland, 52-416
Actively Recruiting
108
Site Number - 7502
Brasov, Romania, 500283
Actively Recruiting
109
Site Number - 7500
Bucharest, Romania, 011172
Actively Recruiting
110
Site Number - 7501
Cluj-Napoca, Romania, 400000
Actively Recruiting
111
Site Number - 7103
Bilbao, Spain, 48013
Actively Recruiting
112
Site Number - 7106
Cadiz, Spain, 11139
Actively Recruiting
113
Site Number - 7101
Córdoba, Spain, 14004
Actively Recruiting
114
Site Number - 7102
Mérida, Spain, 06800
Actively Recruiting
115
Site Number - 7100
Santa Cruz de Tenerife, Spain, 38001
Withdrawn
116
Site Number - 7104
Valencia, Spain, 46010
Actively Recruiting
117
Site Number - 7004
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
118
Site Number - 7003
Liverpool, United Kingdom, L9 7AL
Actively Recruiting
119
Site Number - 7002
London, United Kingdom, NW3 2QG
Actively Recruiting
120
Site Number - 7000
Swindon, United Kingdom, SN3 6BB
Actively Recruiting
121
Site Number - 7001
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
Research Team
C
Central Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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