Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

December 12, 2019

Primary Completion Date

November 12, 2021

Study Completion Date

February 3, 2022

Conditions
Neurodermatitis
Interventions
DRUG

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

Moisturizers

"Pharmaceutical form:~Route of administration: Topical"

DRUG

Low to medium potent topical corticosteroids

"Pharmaceutical form:~Route of administration: Topical"

DRUG

Topical calcineurin inhibitors

"Pharmaceutical form:~Route of administration: Topical"

Trial Locations (63)

13620

Investigational Site Number :4100007, Seongnam-si

19104

Investigational Site Number :8400010, Philadelphia

21431

Investigational Site Number :4100005, Incheon

21565

Investigational Site Number :4100001, Incheon

23502

Investigational Site Number :8400005, Norfolk

29414

Investigational Site Number :8400015, Charleston

30263

Investigational Site Number :8400003, Newnan

30328

Investigational Site Number :8400017, Sandy Springs

31904

Investigational Site Number :8400004, Columbus

33136

Investigational Site Number :8400014, Miami

43016

Investigational Site Number :8400001, Dublin

44100

Investigational Site Number :4840002, Guadalajara

44210

Investigational Site Number :4840006, Guadalajara

45701

Investigational Site Number :8400009, Athens

46250

Investigational Site Number :8400016, Indianapolis

48346

Investigational Site Number :8400018, Clarkston

51100

Investigational Site Number :2500005, Reims

63110

Investigational Site Number :8400013, St Louis

64460

Investigational Site Number :4840001, Monterrey

64718

Investigational Site Number :4840005, Monterrey

72916

Investigational Site Number :8400022, Fort Smith

74136

Investigational Site Number :8400007, Tulsa

77058

Investigational Site Number :8400025, Houston

77401

Investigational Site Number :8400006, Bellaire

78249

Investigational Site Number :8400019, San Antonio

78660

Investigational Site Number :8400002, Pflugerville

85234

Investigational Site Number :8400011, Gilbert

91910

Investigational Site Number :4840003, Veracruz

95816

Investigational Site Number :8400026, Sacramento

100050

Investigational Site Number :1560004, Beijing

107076

Investigational Site Number :6430005, Moscow

115522

Investigational Site Number :6430010, Moscow

125993

Investigational Site Number :6430006, Moscow

197022

Investigational Site Number :6430002, Saint Petersburg

214002

Investigational Site Number :1560003, Wuxi

310006

Investigational Site Number :1560002, Hangzhou

350020

Investigational Site Number :6430007, Krasnodar

355030

Investigational Site Number :6430001, Stavropol

410026

Investigational Site Number :6430009, Saratov

454048

Investigational Site Number :6430008, Chelyabinsk

610041

Investigational Site Number :1560001, Chengdu

08520

Investigational Site Number :8400024, East Windsor

C1023AAB

Investigational Site Number :0320008, CABA

C1055AAO

Investigational Site Number :0320005, CABA

C1425BEN

Investigational Site Number :0320002, CABA

C1425BEA

Investigational Site Number :0320004, CABA

C1431EKK

Investigational Site Number :0320007, CABA

T4000AXL

Investigational Site Number :0320003, San Miguel de Tucumán

C1121ABE

Investigational Site Number :0320001, Buenos Aires

1425DES

Investigational Site Number :0320006, Caba

M5500

Investigational Site Number :0320009, Mendoza

236-0004

Investigational Site Number :3920009, Yokohama

606-8507

Investigational Site Number :3920005, Kyoto

852-8501

Investigational Site Number :3920007, Nagasaki

359-8513

Investigational Site Number :3920003, Tokorozawa-shi

693-8501

Investigational Site Number :3920010, Izumo-shi

113-8519

Investigational Site Number :3920004, Bunkyo-ku

173-8610

Investigational Site Number :3920006, Itabashi-ku

141-8625

Investigational Site Number :3920001, Shinagawa-Ku

454-8509

Investigational Site Number :3920002, Nagoya

03080

Investigational Site Number :4100002, Seoul

03722

Investigational Site Number :4100003, Seoul

07441

Investigational Site Number :4100004, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT04183335 - Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME) | Biotech Hunter | Biotech Hunter