24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 11, 2023

Primary Completion Date

April 2, 2026

Study Completion Date

March 30, 2032

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

LOU064 (blinded)

LOU064 (blinded) active treatment

DRUG

placebo

matching active drug

Trial Locations (63)

2000

RECRUITING

Novartis Investigative Site, Rosario

3584

RECRUITING

Novartis Investigative Site, Utrecht

7405

RECRUITING

Novartis Investigative Site, Cape Town

10330

RECRUITING

Novartis Investigative Site, Bangkok

10700

RECRUITING

Novartis Investigative Site, Bangkok

13353

RECRUITING

Novartis Investigative Site, Berlin

15241

RECRUITING

Allergy and Clinical Immunology Associates, Pittsburgh

27100

RECRUITING

Novartis Investigative Site, Pavia

33134

RECRUITING

Pediatric Dermatology of Miami at the Pediatric CoE, Coral Gables

34093

RECRUITING

Novartis Investigative Site, Istanbul

34137

RECRUITING

Novartis Investigative Site, Trieste

42301

RECRUITING

Allergy and Asthma Specialist P S C, Owensboro

43126

RECRUITING

Novartis Investigative Site, Parma

43617

RECRUITING

Toledo Institute of Clinical Research, Toledo

46014

RECRUITING

Novartis Investigative Site, Valencia

48149

RECRUITING

Novartis Investigative Site, Münster

50139

RECRUITING

Novartis Investigative Site, Florence

53100

RECRUITING

Novartis Investigative Site, Siena

55131

RECRUITING

Novartis Investigative Site, Mainz

60077

RECRUITING

Endeavor Health, Glenview

60590

RECRUITING

Novartis Investigative Site, Frankfurt am Main

70126

RECRUITING

Novartis Investigative Site, Bari

72076

RECRUITING

Novartis Investigative Site, Tübingen

73120

RECRUITING

Allergy Asthma and Clinical Research, Oklahoma City

78213

RECRUITING

RFSA Dermatology, San Antonio

80138

RECRUITING

Novartis Investigative Site, Napoli

83706

RECRUITING

Treasure Valley Medical Research, Boise

84093

RECRUITING

Allergy Associates of Utah, Sandy City

90110

RECRUITING

Novartis Investigative Site, Songkhla

92123

RECRUITING

Allergy and Asthma Medical Group and Research Center, San Diego

93301

RECRUITING

Kern Research, Bakersfield

93586

RECRUITING

Novartis Investigative Site, Kuching

98115

WITHDRAWN

Seattle Allergy and Asthma Rsch, Seattle

100050

RECRUITING

Novartis Investigative Site, Beijing

100069

RECRUITING

Novartis Investigative Site, Beijing

119074

RECRUITING

Novartis Investigative Site, Singapore

229899

RECRUITING

Novartis Investigative Site, Singapore

510091

RECRUITING

Novartis Investigative Site, Guangdong

610041

RECRUITING

Novartis Investigative Site, Chengdu

999077

RECRUITING

Novartis Investigative Site, Hong Kong

RECRUITING

Novartis Investigative Site, Pokfulam

8420383

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Santiago

C1181ACH

RECRUITING

Novartis Investigative Site, CABA

C1414AIF

RECRUITING

Novartis Investigative Site, CABA

C1425BEN

RECRUITING

Novartis Investigative Site, CABA

H4A 3J1

RECRUITING

Novartis Investigative Site, Montreal

807-8556

RECRUITING

Novartis Investigative Site, Kitakyushu

861-3106

RECRUITING

Novartis Investigative Site, Kamimashi-gun

593-8324

RECRUITING

Novartis Investigative Site, Sakai

693 8501

RECRUITING

Novartis Investigative Site, Izumo

173-8610

RECRUITING

Novartis Investigative Site, Itabashi-ku

7416 SE

RECRUITING

Novartis Investigative Site, Deventer

90-436

RECRUITING

Novartis Investigative Site, Lodz

10-045

RECRUITING

Novartis Investigative Site, Olsztyn

02-962

RECRUITING

Novartis Investigative Site, Warsaw

0009

RECRUITING

Novartis Investigative Site, Pretoria

08950

RECRUITING

Novartis Investigative Site, Esplugues de Llobregat

08035

RECRUITING

Novartis Investigative Site, Barcelona

01050

RECRUITING

Novartis Investigative Site, Adana

06230

RECRUITING

Novartis Investigative Site, Ankara

PE3 9GZ

RECRUITING

Novartis Investigative Site, Peterborough

M13 9WL

RECRUITING

Novartis Investigative Site, Manchester

SO16 6YD

RECRUITING

Novartis Investigative Site, Southampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY