A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

June 10, 2024

Primary Completion Date

March 26, 2026

Study Completion Date

April 28, 2028

Conditions
Atopic Dermatitis
Interventions
DRUG

Tralokinumab + TCS

The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.

DRUG

Placebo + TCS

The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.

Trial Locations (71)

1020

RECRUITING

Leo Pharma Investigational site, Brussels

3000

RECRUITING

Leo Pharma Investigational site, Leuven

4000

RECRUITING

Leo Pharma Investigational site, Liège

9000

RECRUITING

Leo Pharma Investigational site, Ghent

10000

RECRUITING

Leo Pharma Investigational site, Zagreb

15355

RECRUITING

Leo Pharma Investigational site, Ansan-si

21614

RECRUITING

Leo Pharma Investigational site, Buxtehude

23502

RECRUITING

Leo Pharma Investigational site, Norfolk

25123

RECRUITING

Leo Pharma Investigational site, Brescia

27420

RECRUITING

Leo Pharma Investigational site, Charleston

28046

RECRUITING

Leo Pharma Investigational site, Madrid

31217

RECRUITING

Leo Pharma Investigational site, Macon

32256

RECRUITING

Leo Pharma Investigational site, Jacksonville

33156

RECRUITING

Leo Pharma Investigational site, Miami

33613

RECRUITING

Leo Pharma Investigational site, Tampa

35128

RECRUITING

Leo Pharma Investigational site, Padua

35209

RECRUITING

Leo Pharma Investigational site, Birmingham

42283

RECRUITING

Leo Pharma Investigational site, Wuppertal

46014

RECRUITING

Leo Pharma Investigational site, Valencia

48328

RECRUITING

Leo Pharma Investigational site, Waterford

49074

RECRUITING

Leo Pharma Investigational site, Osnabrück

51000

RECRUITING

Leo Pharma Investigational site, Rijeka

55131

RECRUITING

Leo Pharma Investigational site, Mainz

60126

RECRUITING

Leo Pharma Investigational site, Ancona

61453

RECRUITING

Leo Pharma Investigational site, Gwangju

72076

RECRUITING

Leo Pharma Investigational site, Tübingen

72117

RECRUITING

Leo Pharma Investigational site, North Little Rock

74136

RECRUITING

Leo Pharma Investigational site, Tulsa

92108

RECRUITING

Leo Pharma Investigational site, San Diego

92123

RECRUITING

Leo Pharma Investigational site, San Diego

94304

RECRUITING

Leo Pharma Investigational site, Palo Alto

95816

RECRUITING

Leo Pharma Investigational site, Sacramento

97239

RECRUITING

Leo Pharma Investigational site, Portland

500091

RECRUITING

Leo Pharma Investigational site, Brasov

700259

RECRUITING

Leo Pharma Investigational site, Iași

L7L 6W6

RECRUITING

Leo Pharma Investigational site, Burlington

Calgary

RECRUITING

Leo Pharma Investigational site, Calgary

T2J 7E1

RECRUITING

Leo Pharma Investigational site, Calgary

T5J 3S9

RECRUITING

Leo Pharma Investigational site, Edmonton

T6G 1C3

RECRUITING

Leo Pharma Investigational site, Edmonton

L8S 1G5

RECRUITING

Leo Pharma Investigational site, Hamilton

L2H 1H5

RECRUITING

Leo Pharma Investigational site, Niagara Falls

S7K 2C1

RECRUITING

Leo Pharma Investigational site, Saskatoon

N8X2G1

RECRUITING

Leo Pharma Investigational site, Windsor

R3M 3Z4

RECRUITING

Leo Pharma Investigational site, Winnipeg

01307

RECRUITING

Leo Pharma Investigational site, Dresden

T12 DFK4

RECRUITING

Leo Pharma Investigational site, Cork

D12N512

RECRUITING

Leo Pharma Investigational site, Crumlin

00168

RECRUITING

Leo Pharma Investigational site, Roma

00165

RECRUITING

Leo Pharma Investigational site, Rome

3584 CW

RECRUITING

Leo Pharma Investigational site, Utrecht

80-546

RECRUITING

Leo Pharma Investigational site, Gdansk

30-002

RECRUITING

Leo Pharma Investigational site, Krakow

90-436

RECRUITING

Leo Pharma Investigational site, Lodz

27-400

RECRUITING

Leo Pharma Investigational site, Ostrowiec Świętokrzyski

35-055

RECRUITING

Leo Pharma Investigational site, Rzeszów

33-100

RECRUITING

Leo Pharma Investigational site, Tarnów

02-953

RECRUITING

Leo Pharma Investigational site, Warsaw

02-962

RECRUITING

Leo Pharma Investigational site, Warsaw

02447

RECRUITING

Leo Pharma Investigational site, Seoul

03080

RECRUITING

Leo Pharma Investigational site, Seoul

03722

RECRUITING

Leo Pharma Investigational site, Seoul

05030

RECRUITING

Leo Pharma Investigational site, Seoul

06273

RECRUITING

Leo Pharma Investigational site, Seoul

06591

RECRUITING

Leo Pharma Investigational site, Seoul

139-711

RECRUITING

Leo Pharma Investigational site, Seoul

03010

RECRUITING

Leo Pharma Investigational site, Alicante

LN2 5QY

RECRUITING

Leo Pharma Investigational site, Lincoln

WC1N 3JH

RECRUITING

Leo Pharma Investigational site, London

S10 2TH

RECRUITING

Leo Pharma Investigational site, Sheffield

SO16 6YD

RECRUITING

Leo Pharma Investigational site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LEO Pharma

INDUSTRY