Actively Recruiting

Phase 2
Age: 18Years - 74Years
All Genders
NCT06979531

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

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Actively Recruiting

25

Site Number - 1024

Grapevine, Texas, United States, 76034

Actively Recruiting

26

Site Number - 1011

Houston, Texas, United States, 77030

Actively Recruiting

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

Actively Recruiting

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

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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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