Actively Recruiting
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Led by Immunovant Sciences GmbH · Updated on 2026-04-21
56
Participants Needed
86
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
CONDITIONS
Official Title
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
- Have a total CLASI-A score of 9 at Screening and Day 1. Participants with a CLASI-A score of 8 and <10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
- Have active CLE despite an adequate trial of conventional therapies.
- Are positive for at least one autoantibody at Screening.
You will not qualify if you...
- Have known or suspected drug-induced CLE, anti-phospholipid disease, or neuropsychiatric SLE.
- Have rapidly progressive nephritis.
- Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
- Other protocol defined Inclusion/Exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Site Number - 1010
Anniston, Alabama, United States, 36207-4780
Actively Recruiting
2
Site Number - 1020
Birmingham, Alabama, United States, 35203-4050
Actively Recruiting
3
Site Number - 1038
Phoenix, Arizona, United States, 85037
Actively Recruiting
4
Site Number - 1034
Scottsdale, Arizona, United States, 85260
Actively Recruiting
5
Site Number - 1022
Beverly Hills, California, United States, 90211
Actively Recruiting
6
Site Number - 1018
Chula Vista, California, United States, 91910
Actively Recruiting
7
Site Number - 1039
Corona, California, United States, 92882
Actively Recruiting
8
Site Number - 1005
Fremont, California, United States, 94538
Actively Recruiting
9
Site Number - 1023
Los Angeles, California, United States, 90045
Actively Recruiting
10
Site Number - 1000
Aurora, Colorado, United States, 80045-2541
Actively Recruiting
11
Site Number - 1033
Castle Rock, Colorado, United States, 80109-8034
Actively Recruiting
12
Site Number - 1021
Farmington, Connecticut, United States, 06030-2840
Actively Recruiting
13
Site Number - 1014
Hialeah, Florida, United States, 33012
Actively Recruiting
14
Site Number - 1017
Jacksonville, Florida, United States, 32256
Actively Recruiting
15
Site Number - 1028
Miami, Florida, United States, 33122
Actively Recruiting
16
Site Number - 1024
Miami, Florida, United States, 33133
Actively Recruiting
17
Site Number - 1027
Miami, Florida, United States, 33136
Actively Recruiting
18
Site Number - 1011
Miami Lakes, Florida, United States, 33014-5602
Actively Recruiting
19
Site Number - 1025
Orlando, Florida, United States, 32819
Actively Recruiting
20
Site Number - 1009
Buford, Georgia, United States, 30518-8721
Actively Recruiting
21
Site Number - 1030
Brighton, Massachusetts, United States, 02135
Actively Recruiting
22
Site Number - 1019
Auburn Hills, Michigan, United States, 48326-3396
Actively Recruiting
23
Site Number - 1003
Saint Clair Shores, Michigan, United States, 48081-1274
Actively Recruiting
24
Site Number - 1013
Troy, Michigan, United States, 48084 3536
Actively Recruiting
25
Site Number - 1004
Saint Joseph, Missouri, United States, 64506-2459
Actively Recruiting
26
Site Number - 1026
St Louis, Missouri, United States, 63104
Actively Recruiting
27
Site Number - 1007
Charlotte, North Carolina, United States, 28211-1064
Actively Recruiting
28
Site Number - 1008
Durham, North Carolina, United States, 27713-8505
Actively Recruiting
29
Site Number - 1006
Smithfield, North Carolina, United States, 27577-4664
Actively Recruiting
30
Site Number - 1002
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
31
Site Number - 1015
Philadelphia, Pennsylvania, United States, 19103-4708
Actively Recruiting
32
Site Number - 1035
Houston, Texas, United States, 77030
Actively Recruiting
33
Site Number - 1012
Irving, Texas, United States, 75061
Actively Recruiting
34
Site Number -5004
CABA, Argentina, 1406
Actively Recruiting
35
Site Number - 5000
CABA, Argentina, C1023AAB
Actively Recruiting
36
Site Number - 5001
CABA, Argentina, C1425DND
Actively Recruiting
37
Site Number - 5002
San Miguel de Tucumán, Argentina, T4000AXL
Actively Recruiting
38
Site Number - 5003
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
39
Site Number - 5601
Sofia, Bulgaria, 1257
Actively Recruiting
40
Site Number - 5603
Sofia, Bulgaria, 1431
Actively Recruiting
41
Site Number - 5600
Sofia, Bulgaria, 1606
Actively Recruiting
42
Site Number - 5605
Sofia, Bulgaria, 1618
Actively Recruiting
43
Site Number - 5606
Sofia, Bulgaria, 1680
Actively Recruiting
44
Site Number - 2000
Calgary, Alberta, Canada, T2W 4X9
Actively Recruiting
45
Site Number - 2002
Vancouver, British Columbia, Canada, V5Z 4E8
Actively Recruiting
46
Site Number - 2003
Sarnia, Ontario, Canada, N7T 5W4
Actively Recruiting
47
Site Number - 5702
Independencia, Chile, 8380000
Actively Recruiting
48
Site Number - 5704
Santiago, Chile, 7640881
Actively Recruiting
49
Site Number - 5703
Santiago, Chile, 8320000
Actively Recruiting
50
Site Number - 5701
Temuco, Chile, 4810345
Actively Recruiting
51
Site Number - 5700
Victoria, Chile, 4720638
Actively Recruiting
52
Site Number - 8002
Tbilisi, Georgia, 0112
Actively Recruiting
53
Site Number - 8000
Tbilisi, Georgia, 0160
Actively Recruiting
54
Site Number - 6502
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
55
Site Number - 6500
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
56
Site Number - 6501
Oldenburg, Lower Saxony, Germany, 26133
Actively Recruiting
57
Site Number - 6503
Bochum, North Rhine-Westphalia, Germany, 44791
Actively Recruiting
58
Site Number - 3902
Attiki, Athens, Greece, 104 31
Actively Recruiting
59
Site Number - 3901
Athens, Attica, Greece, 16121
Actively Recruiting
60
Site Number - 3903
Thessaloniki, Central Macedonia, Greece, 56403
Actively Recruiting
61
Site Number - 3905
Thessaloniki, Central Macedonia, Greece, 56403
Actively Recruiting
62
Site Number - 3906
Heraklion, Crete, Greece, 71110
Actively Recruiting
63
Site Number - 3900
Attiki, Greece, 12462
Actively Recruiting
64
Site Number - 3904
Larissa, Greece, 411 10
Actively Recruiting
65
Site Number - 3004
Poznan, Greater Poland Voivodeship, Poland, 60-702
Actively Recruiting
66
Site Number - 3005
Gorzów Wielkopolski, Lubusz Voivodeship, Poland, 66-400
Actively Recruiting
67
Site Number - 3000
Warsaw, Masovian Voivodeship, Poland, 00-716
Actively Recruiting
68
Site Number - 3001
Warsaw, Masovian Voivodeship, Poland, 00-874
Actively Recruiting
69
Site Number - 3006
Rzeszów, Pakistan, Poland, 35-055
Actively Recruiting
70
Site Number - 3002
Rzeszów, Podkarpackie Voivodeship, Poland, 35-309
Actively Recruiting
71
Site Number - 3003
Lodz, Poland, 90-436
Actively Recruiting
72
Site Number-1029
Caguas, Puerto Rico, 00725-2443
Actively Recruiting
73
Site Number - 1037
Ponce, Puerto Rico, 00716-0377
Actively Recruiting
74
Site Number - 1036
San Juan, Puerto Rico, 918
Actively Recruiting
75
Site Number - 9000
Belgrade, Serbia, 11000
Actively Recruiting
76
Site Number - 9001
Belgrade, Serbia, 11000
Actively Recruiting
77
Site Number - 9003
Novi Sad, Serbia, 21000
Actively Recruiting
78
Site Number - 7104
Badalona, Catalonia, Spain, 8916
Actively Recruiting
79
Site Number - 7105
Pamplona, Navarre, Spain, 31008
Actively Recruiting
80
Site Number - 7101
Burjassot, Valencia, Spain, 46100
Actively Recruiting
81
Site Number - 7100
Madrid, Spain, 28003
Actively Recruiting
82
Site Number - 7102
Madrid, Spain, 28041
Actively Recruiting
83
Site Number - 7103
Málaga, Spain, 29016
Actively Recruiting
84
Site Number - 7002
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Actively Recruiting
85
Site Number - 7003
London, United Kingdom, SE1 9RT
Actively Recruiting
86
Site Number - 7000
Manchester, United Kingdom, M15 6SE
Actively Recruiting
Research Team
C
Central Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here