A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

Last updated: April 20, 2026
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Systemic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Lupus

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT06980805
IMVT-1402-2701
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with orwithout systemic LE manifestations.

  • Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with aCLASI-A score of ≥8 and <10 are eligible if the score does not include alopeciaand/or mucous membrane lesions.

  • Have active CLE despite an adequate trial of conventional therapies.

  • Are positive for at least one autoantibody at Screening.

Exclusion

Exclusion Criteria:

  • Have known or suspected drug-induced CLE anti-phospholipid disease, orneuropsychiatric SLE.

  • Have rapidly progressive nephritis.

  • Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion ofthe Investigator, could interfere with the inflammatory skin assessments or confoundthe disease activity assessments.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 19, 2025
Estimated Completion Date:
April 30, 2027

Study Description

The total study duration per participant is approximately 61 weeks.

Connect with a study center

  • Site Number - 5000

    CABA, C1023AAB
    Argentina

    Active - Recruiting

  • Site Number - 5001

    CABA, C1425DND
    Argentina

    Active - Recruiting

  • Site Number -5004

    CABA, 1406
    Argentina

    Active - Recruiting

  • Site Number - 5002

    San Miguel de Tucumán, T4000AXL
    Argentina

    Active - Recruiting

  • Site Number - 5003

    San Miguel de Tucumán, T4000IHE
    Argentina

    Active - Recruiting

  • Site Number - 5002

    San Miguel de Tucumán 3836873, T4000AXL
    Argentina

    Site Not Available

  • Site Number - 5003

    San Miguel de Tucumán 3836873, T4000IHE
    Argentina

    Active - Recruiting

  • Site Number - 5600

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • Site Number - 5601

    Sofia, 1257
    Bulgaria

    Active - Recruiting

  • Site Number - 5603

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • Site Number - 5605

    Sofia, 1618
    Bulgaria

    Active - Recruiting

  • Site Number - 5606

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • Site Number - 5600

    Sofia 727011, 1606
    Bulgaria

    Active - Recruiting

  • Site Number - 5601

    Sofia 727011, 1257
    Bulgaria

    Active - Recruiting

  • Site Number - 5603

    Sofia 727011, 1431
    Bulgaria

    Site Not Available

  • Site Number - 5605

    Sofia 727011, 1618
    Bulgaria

    Active - Recruiting

  • Site Number - 5606

    Sofia 727011, 1680
    Bulgaria

    Active - Recruiting

  • Site Number - 2000

    Calgary, Alberta T2W 4X9
    Canada

    Active - Recruiting

  • Site Number - 2002

    Vancouver, British Columbia V5Z 4E8
    Canada

    Active - Recruiting

  • Site Number - 2003

    Sarnia, Ontario N7T 5W4
    Canada

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  • Site Number - 2003

    Sarnia 6141190, Ontario 6093943 N7T 5W4
    Canada

    Site Not Available

  • Site Number - 5702

    Independencia, 8380000
    Chile

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  • Site Number - 5702

    Independencia 7114107, 8380000
    Chile

    Site Not Available

  • Site Number - 5703

    Santiago, 8320000
    Chile

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  • Site Number - 5704

    Santiago, 7640881
    Chile

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  • Site Number - 5703

    Santiago 3871336, 8320000
    Chile

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  • Site Number - 5704

    Santiago 3871336, 7640881
    Chile

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    Temuco, 4810345
    Chile

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  • Site Number - 5701

    Temuco 3870011, 4810345
    Chile

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  • Site Number - 5700

    Victoria, 4720638
    Chile

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  • Site Number - 5700

    Victoria 3868326, 4720638
    Chile

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  • Site Number - 8000

    Tbilisi, 0160
    Georgia

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  • Site Number - 8002

    Tbilisi, 0112
    Georgia

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  • Site Number - 8000

    Tbilisi 611717, 0160
    Georgia

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    Tbilisi 611717, 0112
    Georgia

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  • Site Number - 6502

    Tübingen, Baden-Wurttemberg 72076
    Germany

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  • Site Number - 6502

    Tübingen 2820860, Baden-Wurttemberg 2953481 72076
    Germany

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  • Site Number - 6500

    Erlangen, Bavaria 91054
    Germany

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  • Site Number - 6500

    Erlangen 2929567, Bavaria 2951839 91054
    Germany

    Site Not Available

  • Site Number - 6501

    Oldenburg, Lower Saxony 26133
    Germany

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  • Site Number - 6501

    Oldenburg 2857458, Lower Saxony 2862926 26133
    Germany

    Site Not Available

  • Site Number - 6503

    Bochum, North Rhine-Westphalia 44791
    Germany

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  • Site Number - 6503

    Bochum 2947416, North Rhine-Westphalia 2861876 44791
    Germany

    Site Not Available

  • Site Number - 3902

    Attiki, Athens 104 31
    Greece

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  • Site Number - 3902

    Attiki 264354, Athens 104 31
    Greece

    Site Not Available

  • Site Number - 3901

    Athens, Attica 16121
    Greece

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  • Site Number - 3901

    Athens 264371, Attica 6692632 16121
    Greece

    Site Not Available

  • Site Number - 3903

    Thessaloniki, Central Macedonia 56403
    Greece

    Active - Recruiting

  • Site Number - 3905

    Thessaloniki, Central Macedonia 56403
    Greece

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  • Site Number - 3903

    Thessaloniki 734077, Central Macedonia 6697801 56403
    Greece

    Site Not Available

  • Site Number - 3905

    Thessaloniki 734077, Central Macedonia 6697801 56403
    Greece

    Active - Recruiting

  • Site Number - 3906

    Heraklion, Crete 71110
    Greece

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  • Site Number - 3906

    Heraklion 261745, Crete 6697802 71110
    Greece

    Site Not Available

  • Site Number - 3900

    Attiki, 12462
    Greece

    Active - Recruiting

  • Site Number - 3900

    Attiki 264354, 12462
    Greece

    Active - Recruiting

  • Site Number - 3904

    Larissa, 411 10
    Greece

    Active - Recruiting

  • Site Number - 3904

    Larissa 258576, 411 10
    Greece

    Site Not Available

  • Site Number - 3004

    Poznan, Greater Poland Voivodeship 60-702
    Poland

    Active - Recruiting

  • Site Number - 3004

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-702
    Poland

    Site Not Available

  • Site Number - 3005

    Gorzów Wielkopolski, Lubusz Voivodeship 66-400
    Poland

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  • Site Number - 3005

    Gorzów Wielkopolski 3098722, Lubusz Voivodeship 3337494 66-400
    Poland

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  • Site Number - 3000

    Warsaw, Masovian Voivodeship 00-716
    Poland

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  • Site Number - 3001

    Warsaw, Masovian Voivodeship 00-874
    Poland

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  • Site Number - 3000

    Warsaw 756135, Masovian Voivodeship 858787 00-716
    Poland

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  • Site Number - 3001

    Warsaw 756135, Masovian Voivodeship 858787 00-874
    Poland

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    Rzeszów, Pakistan 35-055
    Poland

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  • Site Number - 3006

    Rzeszów 759734, Pakistan 35-055
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  • Site Number - 3002

    Rzeszów, Podkarpackie Voivodeship 35-309
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  • Site Number - 3002

    Rzeszów 759734, Podkarpackie Voivodeship 858788 35-309
    Poland

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    Lodz, 90-436
    Poland

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  • Site Number - 3003

    Lodz 3093133, 90-436
    Poland

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  • Site Number-1029

    Caguas, 00725-2443
    Puerto Rico

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  • Site Number-1029

    Caguas 4563008, 00725-2443
    Puerto Rico

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  • Site Number - 1037

    Ponce, 00716-0377
    Puerto Rico

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  • Site Number - 1037

    Ponce 4566880, 00716-0377
    Puerto Rico

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    San Juan, 918
    Puerto Rico

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  • Site Number - 1036

    San Juan 4568127, 918
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  • Site Number - 9000

    Belgrade, 11000
    Serbia

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  • Site Number - 9001

    Belgrade, 11000
    Serbia

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  • Site Number - 9000

    Belgrade 792680, 11000
    Serbia

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  • Site Number - 9001

    Belgrade 792680, 11000
    Serbia

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  • Site Number - 9003

    Novi Sad, 21000
    Serbia

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  • Site Number - 9003

    Novi Sad 3194360, 21000
    Serbia

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  • Site Number - 7104

    Badalona, Catalonia 8916
    Spain

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  • Site Number - 7104

    Badalona 3129028, Catalonia 3336901 8916
    Spain

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  • Site Number - 7105

    Pamplona, Navarre 31008
    Spain

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  • Site Number - 7105

    Pamplona 3114472, Navarre 3115609 31008
    Spain

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  • Site Number - 7101

    Burjassot, Valencia 46100
    Spain

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  • Site Number - 7101

    Burjassot 2520712, Valencia 2593113 46100
    Spain

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  • Site Number - 7100

    Madrid, 28003
    Spain

    Active - Recruiting

  • Site Number - 7102

    Madrid, 28041
    Spain

    Active - Recruiting

  • Site Number - 7100

    Madrid 3117735, 28003
    Spain

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  • Site Number - 7102

    Madrid 3117735, 28041
    Spain

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  • Site Number - 7103

    Málaga, 29016
    Spain

    Active - Recruiting

  • Site Number - 7103

    Málaga 2514256, 29016
    Spain

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  • Site Number - 7000

    Liverpool 2644210, Merseyside L22 0LG
    United Kingdom

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  • Site Number - 7002

    Leeds, West Yorkshire LS7 4SA
    United Kingdom

    Active - Recruiting

  • Site Number - 7002

    Leeds 2644688, West Yorkshire LS7 4SA
    United Kingdom

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    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Site Number - 7003

    London 2643743, SE1 9RT
    United Kingdom

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  • Site Number - 7000

    Manchester, M15 6SE
    United Kingdom

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  • Site Number - 7000

    Manchester 2643123, M15 6SE
    United Kingdom

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  • Site Number - 1010

    Anniston, Alabama 36207-4780
    United States

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  • Site Number - 1020

    Birmingham, Alabama 35203-4050
    United States

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  • Site Number - 1010

    Anniston 4830198, Alabama 4829764 36207-4780
    United States

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  • Site Number - 1020

    Birmingham 4049979, Alabama 4829764 35203-4050
    United States

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  • Site Number - 1038

    Phoenix, Arizona 85037
    United States

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  • Site Number - 1034

    Scottsdale, Arizona 85260
    United States

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  • Site Number - 1038

    Phoenix 5308655, Arizona 5551752 85037
    United States

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  • Site Number - 1034

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Site Not Available

  • Site Number - 1022

    Beverly Hills, California 90211
    United States

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  • Site Number - 1018

    Chula Vista, California 91910
    United States

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  • Site Number - 1039

    Corona, California 92882
    United States

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  • Site Number - 1005

    Fremont, California 94538
    United States

    Active - Recruiting

  • Site Number - 1023

    Los Angeles, California 90045
    United States

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  • Site Number - 1018

    San Diego, California 92108
    United States

    Site Not Available

  • Site Number - 1022

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Site Number - 1018

    Chula Vista 5336899, California 5332921 91910
    United States

    Site Not Available

  • Site Number - 1039

    Corona 5339631, California 5332921 92882
    United States

    Site Not Available

  • Site Number - 1005

    Fremont 5350734, California 5332921 94538
    United States

    Site Not Available

  • Site Number - 1023

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Site Number - 1000

    Aurora, Colorado 80045-2541
    United States

    Active - Recruiting

  • Site Number - 1033

    Castle Rock, Colorado 80109-8034
    United States

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  • Site Number - 1000

    Aurora 5412347, Colorado 5417618 80045-2541
    United States

    Site Not Available

  • Site Number - 1033

    Castle Rock 5416329, Colorado 5417618 80109-8034
    United States

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  • Site Number - 1021

    Farmington, Connecticut 06030-2840
    United States

    Active - Recruiting

  • Site Number - 1021

    Farmington 4834272, Connecticut 4831725 06030-2840
    United States

    Site Not Available

  • Site Number - 1014

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Site Number - 1017

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Site Number - 1024

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Site Number - 1027

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Site Number - 1028

    Miami, Florida 33122
    United States

    Active - Recruiting

  • Site Number - 1011

    Miami Lakes, Florida 33014-5602
    United States

    Active - Recruiting

  • Site Number - 1025

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Site Number - 1014

    Hialeah 4158476, Florida 4155751 33012
    United States

    Site Not Available

  • Site Number - 1017

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Site Number - 1024

    Miami 4164138, Florida 4155751 33133
    United States

    Active - Recruiting

  • Site Number - 1027

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Site Number - 1028

    Miami 4164138, Florida 4155751 33122
    United States

    Active - Recruiting

  • Site Number - 1011

    Miami Lakes 4164186, Florida 4155751 33014-5602
    United States

    Site Not Available

  • Site Number - 1025

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Site Number - 1009

    Buford, Georgia 30518-8721
    United States

    Active - Recruiting

  • Site Number - 1009

    Sugar Hill, Georgia 30518
    United States

    Site Not Available

  • Site Number - 1009

    Buford 4185110, Georgia 4197000 30518-8721
    United States

    Site Not Available

  • Site Number - 1030

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • Site Number - 1030

    Brighton 4931353, Massachusetts 6254926 02135
    United States

    Site Not Available

  • Site Number - 1019

    Auburn Hills, Michigan 48326-3396
    United States

    Active - Recruiting

  • Site Number - 1003

    Saint Clair Shores, Michigan 48081-1274
    United States

    Active - Recruiting

  • Site Number - 1013

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Site Number - 1013

    Troy, Michigan 48084 3536
    United States

    Active - Recruiting

  • Site Number - 1019

    Auburn Hills 4984565, Michigan 5001836 48326-3396
    United States

    Site Not Available

  • Site Number - 1003

    Saint Clair Shores 5010978, Michigan 5001836 48081-1274
    United States

    Site Not Available

  • Site Number - 1013

    Troy 5012639, Michigan 5001836 48084 3536
    United States

    Site Not Available

  • Site Number - 1004

    Saint Joseph, Missouri 64506-2459
    United States

    Active - Recruiting

  • Site Number - 1026

    St Louis, Missouri 63104
    United States

    Active - Recruiting

  • Site Number - 1004

    Saint Joseph 4407010, Missouri 4398678 64506-2459
    United States

    Site Not Available

  • Site Number - 1026

    St Louis 4407066, Missouri 4398678 63104
    United States

    Site Not Available

  • Site Number - 1007

    Charlotte, North Carolina 28211-1064
    United States

    Active - Recruiting

  • Site Number - 1008

    Durham, North Carolina 27713-8505
    United States

    Active - Recruiting

  • Site Number - 1006

    Smithfield, North Carolina 27577-4664
    United States

    Active - Recruiting

  • Site Number - 1007

    Charlotte 4460243, North Carolina 4482348 28211-1064
    United States

    Site Not Available

  • Site Number - 1008

    Durham 4464368, North Carolina 4482348 27713-8505
    United States

    Site Not Available

  • Site Number - 1006

    Smithfield 4492168, North Carolina 4482348 27577-4664
    United States

    Site Not Available

  • Site Number - 1002

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Site Number - 1015

    Philadelphia, Pennsylvania 19103-4708
    United States

    Active - Recruiting

  • Site Number - 1002

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • Site Number - 1015

    Philadelphia 4560349, Pennsylvania 6254927 19103-4708
    United States

    Site Not Available

  • Site Number - 1012

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Site Number - 1035

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Site Number - 1012

    Irving, Texas 75061
    United States

    Active - Recruiting

  • Site Number - 1035

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Site Number - 1012

    Irving 4700168, Texas 4736286 75061
    United States

    Site Not Available

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