A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

August 28, 2023

Primary Completion Date

May 5, 2025

Study Completion Date

September 22, 2025

Conditions
Atopic DermatitisAtopic Hand Eczema
Interventions
DRUG

Tralokinumab

After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants are administered a dose of 300 mg every two weeks for 32 weeks

DRUG

Placebo

After a loading dose under the skin (s.c.) at baseline, trial participants are administered a placebo dose every two weeks for 16 weeks

Trial Locations (69)

1200

LEO Pharma Investigational Site, Brussels

2650

LEO Pharma Investigational Site, Edegem

4564

LEO Pharma Investigational Site, Seoul

9000

LEO Pharma Investigational site, Ghent

10075

LEO Pharma Investigational Site, New York

13045

LEO Pharma Investigational Site, Cortland

15355

LEO Pharma Investigational Site, Ansan-si

18016

LEO Pharma Investigational site, Granada

26426

LEO Pharma Investigational Site, Wŏnju

33012

LEO Pharma Investigational Site, Hialeah

35209

LEO Pharma Investigational Site, Birmingham

37211

LEO Pharma Investigational Site, Nashville

40217

LEO Pharma Investigational Site, Louisville

41944

LEO Pharma Investigational Site, Daegu

42283

LEO Pharma Investigational Site, Wuppertal

44093

LEO Pharma Investigational Site, Nantes

46168

LEO Pharma Investigational Site, Plainfield

48202

LEO Pharma Investigational Site, Detroit

49074

LEO Pharma Investigational Site, Osnabrück

49316

LEO Pharma Investigational Site, Caledonia

55128

LEO Investigational Site, Bretzenheim

60590

LEO Pharma Investigational Site, Frankfurt am Main

69495

LEO Pharma Investigational Site, Pierre-Bénite

70115

LEO Pharma Investigational Site, New Orleans

72076

LEO Pharma Investigational Site, Tübingen

72916

LEO Pharma Investigational Site, Fort Smith

75034

LEO Pharma Investigational Site, Frisco

75225

LEO Pharma Investigational Site, Dallas

76031

LEO Pharma Investigational Site, Rouen

77598

LEO Pharma Investigational Site, Webster

78213

LEO Pharma Investigational Site, San Antonio

90025

LEO Pharma Investigational Site, Los Angeles

92708

LEO Pharma Investigational Site, Fountain Valley

95816

LEO Pharma Investigational Site, Sacramento

97201

LEO Pharma Investigational Site, Portland

97210

LEO Pharma Investigational Site, Portland

97437

LEO Pharma Investigational Site, Haßfurt

06032

LEO Pharma Investigational Site, Farmington

04401

LEO Pharma Investigational Site, Bangor

03801

LEO Pharma Investigational Site, Portsmouth

T3E 0B2

LEO Pharma Investigational Site, Calgary

T5J 3S9

LEO Pharma Investigational Site, Edmonton

T6X 0N9

LEO Pharma Investigational Site, Edmonton

T4P 1K4

LEO Pharma Investigational Site, Red Deer

V3R 6A7

LEO Pharma Investigational Site, Surrey

E3B 1G9

LEO Pharma Investigational Site, Fredericton

L8L 3C3

LEO Pharma Investigational Site, Hamilton

L4B 1A5

LEO Pharma Investigational Site, Richmond Hill

M2N 3A6

LEO Pharma Investigational Site, Toronto

N8T 1E6

LEO Pharma Investigational Site, Windsor

J7Z 7E2

LEO Pharma Investigational Site, Saint-Jérôme

G1V 4X7

LEO Pharma Investigational Site, Québec

G1W 4R4

LEO Pharma Investigational Site, Québec

1105 AZ

LEO Pharma Investigational Site, Amsterdam

9713 GZ

LEO Pharma Investigational Site, Groningen

80-462

LEO Pharma Investigational Site, Gdansk

30-033

LEO Pharma Investigational Site, Krakow

31-011

LEO Pharma Investigational Site, Krakow

05278

LEO Pharma Investigational Site, Yangsan

LEO Pharma Investigational Site, Seoul

03080

LEO Pharma Investigational Site, Seoul

04763

LEO Pharma Investigational Site, Seoul

05030

LEO Pharma Investigational Site, Seoul

08916

LEO Pharma Investigational Site, Badalona

LEO Pharma Investigational site, Barcelona

03010

LEO Pharma Investigational site, Alicante

M6 8HD

LEO Pharma Investigational Site, Salford

TS4 3BW

LEO Pharma Investigational Site, Middlesbrough

SE1 7EH

LEO Pharma Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LEO Pharma

INDUSTRY

NCT05958407 - A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy | Biotech Hunter | Biotech Hunter