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An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Primary Purpose

Chronic Spontaneous Urticaria

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LOU064

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Chronic spontaneous urticaria, BTK Inhibitor, Long term safety, Urticaria activity score

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
Subjects rolling over from CLOU064A2201 must have completed the Week 12 visit (end of treatment period) or the Week 16 visit (end of the follow-up period) and will be allocated to the treatment period or the observational period of CLOU064A2201E1 based on the UAS7 score (of the 7 days prior to the respective visit) as follows:
- Subjects rolling over at Week 12 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period (note: subjects with UAS7<16 at Week 12 are not eligible to roll-over into CLOU064A2201E1 but need to enter the follow-up period of CLOU064A2201).
- Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period.
- Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7<16 will be allocated to the Observational period.

Exclusion Criteria:

Subjects having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticarial
Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticarial
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.
History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study such as:
- Concomitant clinically significant cardiac arrhythmias, eg sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Pointes
- Resting heart rate (physical exam or 12 lead ECG) < 60 bpm
- Resting QTcF ≥450 msec (male) or ≥460 msec (female) at day 1 of the treatment period or inability to determine the QTcF interval
- Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
Significant bleeding risk or coagulation disorders
Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C

Other protocol defined inclusion exclusion criteria may apply

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

Participants with UAS7<16 at Week 16 of CLOU064A2201 were followed up to 12 weeks without receiving treatment (observational period). If participants relapsed (UAS7≥16 at least once), they were transitioned to the treatment period. Otherwise, they were discontinued from the study. Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered 100 mg of LOU064 b.i.d. open-label for up to 52 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (AEs)

An AE refers to any undesirable medical occurrence, such as an unintended sign (including abnormal laboratory findings), symptom, or disease, experienced by a participant. Serious AEs (SAEs) is defined as any AE that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or any other medically significant condition. Treatment-emergent AEs were defined as AEs that either begin on the same day or after the first dose of study medication during the treatment period in the extension study or worsen on the same day or after the first dose of study medication in the extension study and within the minimum of either 28 days post last dose or the end of the study visit. The number of participants with treatment-emergent AEs was summarized.

Secondary Outcome Measures

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 of the Treatment Period

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The change from baseline in UAS7 at Week 4 of the treatment period was calculated. A negative change score from baseline indicates improvement. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.

Percentage of Participants With Well-controlled Disease (UAS7≤6) at Week 4 of the Treatment Period

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing values were imputed by non-responder imputation method regardless of the reason for missingness. The percentage of subjects with UAS7≤ 6 at Week 4 of the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction.

Percentage of Participants With Complete Response (UAS7=0) at Week 4 of the Treatment Period

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing values were imputed by non-responder imputation method regardless of the reason for missingness. The percentage of subjects with UAS7= 0 at Week 4 of the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction.

Percentage of Participants With Well-controlled Disease (UAS7≤ 6) Overtime

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The percentage of subjects with UAS7≤ 6 during the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.

Change From Baseline in UAS7 Overtime

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The change from baseline in UAS7 during the treatment period was calculated. A negative change score from baseline indicates improvement. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.

Full Information

NCT ID

NCT04109313

First Posted

September 27, 2019

Last Updated

September 5, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04109313

Brief Title

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Official Title

An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

October 24, 2019 (Actual)

Primary Completion Date

September 9, 2022 (Actual)

Study Completion Date

September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)

Detailed Description

This was an open-label, single-arm, multicenter, long-term safety and tolerability extension study for CSU patients rolling over from study CLOU064A2201 (NCT03926611). Subjects rolling over from CLOU064A2201 with a weekly Urticaria Activity Score (UAS7)<16 after the follow-up period at Week 16 were further followed up without receiving LOU064 for up to 12 weeks (observational period). If there was a relapse (UAS7≥16 at least once), the 12-week observational period was terminated, and subjects entered the treatment period. Subjects who never relapsed within 12 weeks completed the study after the observational period without treatment. Subjects who rolled over from CLOU064A2201 with a UAS7≥16 at Week 12 or Week 16, as well as those subjects who relapsed during the 12-week observational period, were treated with 100 mg LOU064 twice a day (b.i.d.) open-label for 52 weeks. No background medication with a second-generation H1-antihistamine was permitted up to Week 4 of the treatment period. Subjects who completed the treatment period or who discontinued treatment early were followed-up for a minimum duration of 4 weeks. Subjects who had a UAS7≤6 at Week 52 of the treatment period had their follow-up period extended until relapse (UAS7≥16) for up to a total of 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Spontaneous Urticaria

Keywords

Chronic spontaneous urticaria, BTK Inhibitor, Long term safety, Urticaria activity score

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

229 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All participants

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

LOU064

Intervention Description

Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period.

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events (AEs)

Description

Time Frame

From first dose of treatment up to 28 days after last dose, assessed up to 56 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 of the Treatment Period

Description

Time Frame

Baseline, Week 4 of treatment period

Title

Percentage of Participants With Well-controlled Disease (UAS7≤6) at Week 4 of the Treatment Period

Description

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing values were imputed by non-responder imputation method regardless of the reason for missingness. The percentage of subjects with UAS7≤ 6 at Week 4 of the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction.

Time Frame

Week 4 of the treatment period

Title

Percentage of Participants With Complete Response (UAS7=0) at Week 4 of the Treatment Period

Description

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing values were imputed by non-responder imputation method regardless of the reason for missingness. The percentage of subjects with UAS7= 0 at Week 4 of the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction.

Time Frame

Week 4 of the treatment period

Title

Percentage of Participants With Well-controlled Disease (UAS7≤ 6) Overtime

Description

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The percentage of subjects with UAS7≤ 6 during the treatment period was calculated. The 90% confidence interval was derived based on the score method with continuity correction. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.

Time Frame

From baseline until Week 52 of the treatment period

Title

Change From Baseline in UAS7 Overtime

Description

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The change from baseline in UAS7 during the treatment period was calculated. A negative change score from baseline indicates improvement. The UAS7 at baseline was considered as the UAS7 derived over the last 7 days before day 1 of the treatment period.

Time Frame

From baseline until Week 52 of the treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Participants must provide written informed consent prior to any assessments. Participants must be willing and able to complete a daily symptom eDiary throughout the study and adhere to the study visit schedules. Participants transitioning from the CLOU064A2201 trial must have completed either the Week 12 visit (end of treatment period) or the Week 16 visit (end of follow-up period). They will be assigned to either the treatment period or the observational period based on their UAS7 score (average score from the 7 days prior to the respective visit) as follows: Participants transitioning at Week 12 of CLOU064A2201 with a UAS7 score of ≥16 will be allocated to the treatment period. Participants transitioning at Week 16 of CLOU064A2201 with a UAS7 score of ≥16 will be allocated to the treatment period. Participants transitioning at Week 16 of CLOU064A2201 with a UAS7 score of <16 will be allocated to the observational period. Key Exclusion Criteria: Participants with a clearly defined predominant or sole trigger for their chronic urticaria, such as chronic inducible urticaria (including symptomatic dermographism, cold-induced, heat-induced, solar-induced, pressure-induced, delayed pressure-induced, aquagenic-induced, cholinergic-induced, or contact-induced urticaria). Participants with other diseases presenting with urticaria or angioedema symptoms, including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria. Participants with any other skin disease associated with chronic itching that, in the opinion of the investigator, could affect the study evaluations and results, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. Participants with a history or current diagnosis of ECG abnormalities that indicate a significant safety risk for their participation in the study, including: Concomitant clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia) and clinically significant second or third-degree AV block without a pacemaker. History of familiar long QT syndrome or a known family history of Torsades de Pointes. Resting heart rate (as determined by physical exam or 12-lead ECG) below 50 bpm. Resting QTcF interval ≥450 msec (in males) or ≥460 msec (in females) at day 1 of the treatment period or inability to determine the QTcF interval. Use of agents known to prolong the QT interval, unless they can be permanently discontinued for the duration of the study. Participants with a significant risk of bleeding or coagulation disorders. Participants with a known or suspected history of an ongoing, chronic, or recurrent infectious disease, including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis, or aspergillosis), HIV, or Hepatitis B/C.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceutical

Organizational Affiliation

Novartis Pharmaceutical

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Novartis Investigative Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Novartis Investigative Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Novartis Investigative Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novartis Investigative Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Novartis Investigative Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Facility Name

Novartis Investigative Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Grove City

State/Province

Ohio

ZIP/Postal Code

43123

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1902COS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad de Mendoza

State/Province

Mendoza

ZIP/Postal Code

M5500AWD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

ZIP/Postal Code

1035

Country

Argentina

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6H 5L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Niagara Falls

State/Province

Ontario

ZIP/Postal Code

L2H 1H5

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Novartis Investigative Site

City

Verdun

State/Province

Quebec

ZIP/Postal Code

H4G 3E7

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Novartis Investigative Site

City

Prague 8

State/Province

Czech Republic

ZIP/Postal Code

180 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague

State/Province

Prague 1

ZIP/Postal Code

11000

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tabor

ZIP/Postal Code

390 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Arhus C

ZIP/Postal Code

DK 8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Oroshaza

State/Province

Bekes

ZIP/Postal Code

5900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Ichinomiya

State/Province

Aichi

ZIP/Postal Code

491-0041

Country

Japan

Facility Name

Novartis Investigative Site

City

Funabashi

State/Province

Chiba

ZIP/Postal Code

273-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima City

State/Province

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro

State/Province

Hokkaido

ZIP/Postal Code

080 0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

220-6208

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

221-0825

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

240-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Takaoka

State/Province

Toyama

ZIP/Postal Code

933-0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 803

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Novartis Investigative Site

City

Rzeszow

ZIP/Postal Code

35 055

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 777

Country

Poland

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.-Petersburg

ZIP/Postal Code

195112

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

040 15

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nove Zamky

ZIP/Postal Code

940 34

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Svidnik

ZIP/Postal Code

08901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

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An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Chronic Spontaneous Urticaria

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial