Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

PHASE3CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 16, 2020

Primary Completion Date

August 30, 2021

Study Completion Date

November 22, 2021

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 (57)

833

Investigational Site Number :1580006, Kaohsiung City

4032

Investigational Site Number :3480004, Debrecen

5900

Investigational Site Number :3480002, Orosháza

6720

Investigational Site Number :3480003, Szeged

7632

Investigational Site Number :3480005, Pécs

10002

Investigational Site Number :1580001, Taipei

10449

Investigational Site Number :1580002, Taipei

14004

Investigational Site Number :7240004, Córdoba

14584

Investigational Site Number :4100003, Bucheon-si

20089

Investigational Site Number :3800001, Rozzano

20122

Investigational Site Number :3800002, Milan

21205

Investigational Site Number :8400003, Baltimore

21431

Investigational Site Number :4100007, Incheon

28034

Investigational Site Number :7240007, Madrid

29200

Investigational Site Number :2500001, Brest

30059

Investigational Site Number :1580005, Hsinchu

31059

Investigational Site Number :2500003, Toulouse

33028

Investigational Site Number :8400005, Pembroke Pines

33075

Investigational Site Number :2500007, Bordeaux

33619

Investigational Site Number :7240008, Santullano

36071

Investigational Site Number :7240001, Pontevedra

46026

Investigational Site Number :7240003, Valencia

46168

Investigational Site Number :8400002, Plainfield

49241

Investigational Site Number :4100002, Busan

50009

Investigational Site Number :7240002, Zaragoza

51100

Investigational Site Number :2500005, Reims

59037

Investigational Site Number :2500002, Lille

60032

Investigational Site Number :3800004, Ancona

69003

Investigational Site Number :2500006, Lyon

72037

Investigational Site Number :2500008, Le Mans

72916

Investigational Site Number :8400054, Fort Smith

75010

Investigational Site Number :2500004, Paris

77479

Investigational Site Number :8400001, Sugar Land

88100

Investigational Site Number :3800003, Catanzaro

95816

Investigational Site Number :8400008, Sacramento

5110683

Investigational Site Number :1520005, Valdivia

5311523

Investigational Site Number :1520006, Osorno

7580206

Investigational Site Number :1520003, Santiago

7640881

Investigational Site Number :1520001, Santiago

80004005

Investigational Site Number :1520004, Santiago

08520

Investigational Site Number :8400006, East Windsor

T2G 1B1

Investigational Site Number :1240002, Calgary

V3R 6A7

Investigational Site Number :1240006, Surrey

L3P 1X3

Investigational Site Number :1240007, Markham

L3Y 5G8

Investigational Site Number :1240008, Newmarket

M5A 3R6

Investigational Site Number :1240001, Toronto

S7K 0H6

Investigational Site Number :1240009, Saskatoon

Unknown

Investigational Site Number :1520002, Santiago

Investigational Site Number :1580008, Taichung

3000-075

Investigational Site Number :6200001, Coimbra

1998-018

Investigational Site Number :6200002, Lisbon

4099-001

Investigational Site Number :6200003, Porto

03722

Investigational Site Number :4100005, Seoul

06973

Investigational Site Number :4100001, Seoul

07441

Investigational Site Number :4100006, Seoul

08916

Investigational Site Number :7240009, Badalona

RH1 5RH

Investigational Site Number :8260001, Redhill

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY