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Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Primary Purpose

Chronic Spontaneous Urticaria

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ligelizumab

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Anti-IgE, chronic spontaneous urticaria, hives severity score, itch severity score, urticaria activity score, CSU

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Written informed consent
Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Male and female, adult and adolescent subjects ≥12 years of age
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule

Key Exclusion Criteria:

Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
Use of omalizumab within 16 weeks of Screening
History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
Diseases with possible symptoms of urticaria or angioedema
Subjects with evidence of helminthic parasitic infection
Documented history of anaphylaxis
Pregnant or nursing (lactating) women

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS

Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS

Arm Description

Participants received 72 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).

Participants received 120 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).

Outcomes

Primary Outcome Measures

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12

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 transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction.

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study

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 and the intensity of the pruritus 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 UAS7 was missing for that week. Missing data was considered as non-responder. The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies who achieved UAS7 ≤ 6 at week 12 in the core studies with UAS7≤ 6 at Week 12 of the extension study was estimated based on observed data.

Secondary Outcome Measures

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12

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 transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method.

Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

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 negative change score from extension study baseline indicates improvement. 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 absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method.

Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement. A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week. The absolute change from extension study baseline in the ISS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.

Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement. A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week. The absolute change from extension study baseline in the HSS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.

Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease. AAS7 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. The imputed AAS7 = 0 was used for the cumulative number of weeks that subjects achieved AAS7 = 0 response calculation

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12

The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life. The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies with DLQI = 0-1 at Week 12 was estimated using multiple imputation method.

Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration

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 data was considered as non-responder in the analysis. The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data.

Full Information

NCT ID

NCT04210843

First Posted

December 17, 2019

Last Updated

June 20, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04210843

Brief Title

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Official Title

A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU. This decision was not based on any safety concerns.

Study Start Date

April 8, 2020 (Actual)

Primary Completion Date

September 1, 2022 (Actual)

Study Completion Date

September 1, 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

Yes

5. Study Description

Brief Summary

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

Detailed Description

This was a Phase IIIb multi-center, double-blinded and open-label extension study to evaluate efficacy and safety of ligelizumab retreatment with H1-AHs background therapy with an option for ligelizumab monotherapy (i.e., discontinuation of background H1-AH) in adult and adolescent CSU participants who had completed one of the preceding studies, in the setting of retreatment and self-administration. Participants with weekly urticaria activity score (UAS7) < 16 during screening entered the first (investigational treatment-free) observation period (OBS1), with a duration up to 36 weeks. Participants with UAS7 ≥ 16 during screening or OBS1 were assigned to 1 of the 2 treatment arms and entered the treatment period (first half treatment period, referred to as TRT1). The first half treatment period (TRT1) was 52 weeks (from Week 0 to Week 52). Participants remained on the same H1-AH background medication they were taking in the preceding studies. TRT1 was divided into: The first 12 weeks in TRT1: i. participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg liquid in vial subcutaneously (s.c.) every 4 weeks (Q4W) were treated with the same dose regimen in a double-blind manner in this extension study; ii. all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg liquid in vial s.c., Q4W, in a double-blind manner in this extension study; iii. participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg liquid in vial s.c., Q4W in an open-label manner in this extension study. After the first 12 weeks in TRT1 (and up to Week 52), all participants were switched to ligelizumab 120 mg s.c. pre-filled syringe (PFS) Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab outside the clinic. The second half of the treatment period (TRT2) was 52 weeks (from Week 52 to Week 104). Participants with UAS7>6 and <16 or with UAS7 ≥ 16 for whom the benefit-risk was deemed as positive by the investigator at Week 52 of TRT1 were transitioned to the TRT2 (ligelizumab 120 mg s.c. Q4W PFS) unless a decision to stop treatment was made based on a risk-benefit assessment. They were not allowed to discontinue H1- AH background medication. Participants with UAS7 ≤ 6 at Week 52 of TRT1 entered the second (investigational treatment-free) observation period (OBS2) for up to 52 weeks and remained on the same H1-AH background medication they were taking in the preceding studies. Participants with UAS7 ≤ 6 at Week 52 of TRT1 who entered the second observation period (OBS2) and relapsed (UAS7 ≥ 16) were transitioned to the TRT2 and were also offered the opportunity to discontinue their H1-AH background medication (i.e. ligelizumab 120 mg s.c. q4w PFS monotherapy) after 12 weeks in TRT2. Participants who entered the OBS2 and did not relapse (UAS7<16) exited the study at the end of the OBS2 period. Finally, participants who were in TRT2 entered the post-treatment follow-up period after treatment discontinuation, with duration of 12 weeks (for participants who did not complete a continuous 104-week treatment) or 52 weeks (for participants who completed the full 104-week treatment period without interruption). Participants who decided to remain on H1-AH background medication continued to use H1-AH background medication. Participants who decided to go off H1- AH background medication continued to remain off.

6. Conditions and Keywords

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

Chronic Spontaneous Urticaria

Keywords

Anti-IgE, chronic spontaneous urticaria, hives severity score, itch severity score, urticaria activity score, CSU

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated in a double-blind manner for the first 12 weeks of treatment. Thereafter, they were treated in an open-label manner. No blinding was required for participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278)

Allocation

Non-Randomized

Enrollment

1033 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS

Arm Type

Experimental

Arm Description

Arm Title

Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ligelizumab

Other Intervention Name(s)

QGE031

Intervention Description

For the first 12 weeks of treatment: i) participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg LIVI s.c. Q4W were treated with the same dose regimen in a double-blind manner; ii) all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg LIVI s.c. Q4W in a double-blind manner; iii) participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg LIVI s.c. Q4W in an open-label manner. Thereafter, all participants were switched to ligelizumab 120 mg s.c. PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab. The longest possible treatment was 104 weeks, however this treatment might not be continuous and might span over a period of 156 weeks due to the possibility of entering the intervening observation period.

Primary Outcome Measure Information:

Title

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12

Description

Time Frame

Week 12 of the extension study

Title

Description

Time Frame

Week 12 of the extension study

Secondary Outcome Measure Information:

Title

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12

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 transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method.

Time Frame

Week 12 of the extension study

Title

Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

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 negative change score from extension study baseline indicates improvement. 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 absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method.

Time Frame

Extension study baseline (Week 0), Week 12 of the extension study

Title

Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

Description

Time Frame

Extension study baseline (Week 0), Week 12 of the extension study

Title

Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

Description

Time Frame

Extension study baseline (Week 0), Week 12 of the extension study

Title

Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies

Description

Time Frame

From extension study baseline (Week 0) up to Week 12 of the extension study

Title

Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12

Description

Time Frame

Week 12 of the extension study

Title

Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration

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 data was considered as non-responder in the analysis. The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data.

Time Frame

Week 24 of the extension study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Written informed consent Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878) Male and female, adult and adolescent subjects ≥12 years of age Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule Key Exclusion Criteria: Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment Use of omalizumab within 16 weeks of Screening History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356) or CQGE031C2202 (NCT03437278). Diseases with possible symptoms of urticaria or angioedema Subjects with evidence of helminthic parasitic infection Documented history of anaphylaxis Pregnant or nursing (lactating) women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Novartis Investigative Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Novartis Investigative Site

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Novartis Investigative Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

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

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Novartis Investigative Site

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Facility Name

Novartis Investigative Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Novartis Investigative Site

City

Greenacres City

State/Province

Florida

ZIP/Postal Code

33467

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Novartis Investigative Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Novartis Investigative Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

Facility Name

Novartis Investigative Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Novartis Investigative Site

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

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

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

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

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Novartis Investigative Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Novartis Investigative Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Novartis Investigative Site

City

Clackamas

State/Province

Oregon

ZIP/Postal Code

97015

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Novartis Investigative Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29420

Country

United States

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Novartis Investigative Site

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEA

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

Buenos Aires

State/Province

Nueve De Julio

ZIP/Postal Code

B6500BWQ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

State/Province

Rosario

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000BRH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000JKR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Bahia Blanca

ZIP/Postal Code

B8000JRB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425DKG

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

ZIP/Postal Code

1035

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

ZIP/Postal Code

C1023AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Novartis Investigative Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A 1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Jette

State/Province

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Loverval

ZIP/Postal Code

6280

Country

Belgium

Facility Name

Novartis Investigative Site

City

Salvador

State/Province

ZIP/Postal Code

40110-060

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21941-913

Country

Brazil

Facility Name

Novartis Investigative Site

City

Alphaville Barueri

State/Province

Sao Paulo

ZIP/Postal Code

06454010

Country

Brazil

Facility Name

Novartis Investigative Site

City

Santo Andre

State/Province

ZIP/Postal Code

09060 650

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15090 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Novartis Investigative Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B 3S6

Country

Canada

Facility Name

Novartis Investigative Site

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2V 2K1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1P3

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Novartis Investigative Site

City

Vitacura

State/Province

Santiago

ZIP/Postal Code

7640881

Country

Chile

Facility Name

Novartis Investigative Site

City

Osorno

ZIP/Postal Code

5311297

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Novartis Investigative Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

0050010

Country

Colombia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

CZE

ZIP/Postal Code

415 01

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

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Clermont Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Novartis Investigative Site

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31400

Country

France

Facility Name

Novartis Investigative Site

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44793

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06097

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Langenau

ZIP/Postal Code

89129

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Memmingen

ZIP/Postal Code

87700

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrueck

ZIP/Postal Code

49074

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

161 21

Country

Greece

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

1015

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Kecskemet

State/Province

Bacs Kiskun

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

State/Province

Csongrad

ZIP/Postal Code

6720

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

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560004

Country

India

Facility Name

Novartis Investigative Site

City

Belagavi

State/Province

Karnataka

ZIP/Postal Code

590010

Country

India

Facility Name

Novartis Investigative Site

City

Mangalore

State/Province

Karnataka

ZIP/Postal Code

575002

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422005

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422101

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novartis Investigative Site

City

Vijayawada

ZIP/Postal Code

520002

Country

India

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3339419

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09042

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50122

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

454-0012

Country

Japan

Facility Name

Novartis Investigative Site

City

Ichikawa

State/Province

Chiba

ZIP/Postal Code

272-0033

Country

Japan

Facility Name

Novartis Investigative Site

City

Chikushino

State/Province

Fukuoka

ZIP/Postal Code

818 0083

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

Kobe-shi

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Novartis Investigative Site

City

Nishinomiya-city

State/Province

Hyogo

ZIP/Postal Code

663-8186

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

211-0063

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

222-0033

Country

Japan

Facility Name

Novartis Investigative Site

City

Kamimashi-gun

State/Province

Kumamoto

ZIP/Postal Code

861-3106

Country

Japan

Facility Name

Novartis Investigative Site

City

Neyagawa

State/Province

Osaka

ZIP/Postal Code

572-0838

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakai

State/Province

Osaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Novartis Investigative Site

City

Izumo-city

State/Province

Shimane

ZIP/Postal Code

693 8501

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

Machida-city

State/Province

Tokyo

ZIP/Postal Code

194-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinagawa ku

State/Province

Tokyo

ZIP/Postal Code

141 8625

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

819 0167

Country

Japan

Facility Name

Novartis Investigative Site

City

Daegu

State/Province

Dalseo Gu

ZIP/Postal Code

42602

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon-Do

ZIP/Postal Code

26426

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Hwaseong si

State/Province

Gyeonggi Do

ZIP/Postal Code

18450

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Suwon si

State/Province

Gyeonggi Do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

405 760

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

150-950

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

166378

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Saida

ZIP/Postal Code

652

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Ipoh

State/Province

Perak

ZIP/Postal Code

30450

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Penang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Novartis Investigative Site

City

Villahermosa

State/Province

Tabasco

ZIP/Postal Code

86035

Country

Mexico

Facility Name

Novartis Investigative Site

City

Bergen op Zoom

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3584CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Muscat

ZIP/Postal Code

123

Country

Oman

Facility Name

Novartis Investigative Site

City

Miraflores

State/Province

Lima

ZIP/Postal Code

15074

Country

Peru

Facility Name

Novartis Investigative Site

City

San Borja

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Taguig City

State/Province

Metro Manila

ZIP/Postal Code

1634

Country

Philippines

Facility Name

Novartis Investigative Site

City

Pasig City

ZIP/Postal Code

1605

Country

Philippines

Facility Name

Novartis Investigative Site

City

Ksawerow

State/Province

POL

ZIP/Postal Code

95-054

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-530

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

02-507

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50 566

Country

Poland

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 2

ZIP/Postal Code

020762

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400162

Country

Romania

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov on Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390046

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

191123

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

191015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

193231

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

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308205

Country

Singapore

Facility Name

Novartis Investigative Site

City

Kezmarok

ZIP/Postal Code

060 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Komarno

ZIP/Postal Code

945 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nove Zamky

ZIP/Postal Code

940 34

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Povazska Bystrica

ZIP/Postal Code

017 26

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Svidnik

ZIP/Postal Code

08901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Topolcany

ZIP/Postal Code

95501

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cape Town

State/Province

Western Province

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

ZIP/Postal Code

3630

Country

South Africa

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Esplugues de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

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

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46015

Country

Spain

Facility Name

Novartis Investigative Site

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Tao Yuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

State/Province

Phayathai

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Sfax

State/Province

Tunusia

ZIP/Postal Code

3029

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Sousse

ZIP/Postal Code

4000

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Tunis

ZIP/Postal Code

1007

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

Pendik

ZIP/Postal Code

348999

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Aydin

ZIP/Postal Code

09100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Okmeydani

ZIP/Postal Code

34370

Country

Turkey

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

ZIP/Postal Code

7000

Country

Vietnam

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

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

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Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Chronic Spontaneous Urticaria

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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