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A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Primary Purpose

Chronic Spontaneous Urticaria

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ligelizumab

Omalizumab

Placebo

About this trial

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

Eligibility Criteria

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

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Male and female subjects ≥ 12 years of age at the time of screening.
CSU diagnosis for ≥ 6 months.
Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Key Exclusion Criteria:

History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
Prior exposure to ligelizumab or omalizumab.
H1-AH used as background medication at greater than locally label-approved doses after visit 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Ligelizumab 120 mg

Ligelizumab 72 mg

Omalizumab 300 mg

Placebo

Arm Description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48

Outcomes

Primary Outcome Measures

Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects

The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement

Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)

Secondary Outcome Measures

Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)

The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. No Statistical analysis was planned for adolescent group.

Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)

Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.

Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)

Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)

Assessed as percentage of subjects achieving DLQI = 0-1, meaning, no impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). No statistical anaylsis was planned for adolescent group.

Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)

Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.

Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)

Full Information

NCT ID

NCT03580369

First Posted

June 26, 2018

Last Updated

July 20, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03580369

Brief Title

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Official Title

A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 17, 2018 (Actual)

Primary Completion Date

July 16, 2021 (Actual)

Study Completion Date

June 14, 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 study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Detailed Description

This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods: Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility. Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks. Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.

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, CSU, chronic spontaneous urticaria, hives severity score, itch severity score, urticaria activity score

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This was a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Patients, investigator staff and personnel performing the study assessments remained blinded to the identity of the treatment from the time of randomization until final database lock. The study drug was prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator was involved in any assessments.

Allocation

Randomized

Enrollment

1072 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ligelizumab 120 mg

Arm Type

Experimental

Arm Description

Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm Title

Ligelizumab 72 mg

Arm Type

Experimental

Arm Description

Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Arm Title

Omalizumab 300 mg

Arm Type

Active Comparator

Arm Description

Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Ligelizumab

Intervention Description

Liquid in vial

Intervention Type

Biological

Intervention Name(s)

Omalizumab

Intervention Description

Lyophilized powder for solution in vial

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Liquid in vial

Primary Outcome Measure Information:

Title

Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects

Description

Time Frame

Baseline, Week 12

Title

Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)

Description

Time Frame

Week 12

Title

Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)

Description

Time Frame

Baseline, Week 12

Title

Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)

Description

Time Frame

Baseline, Week 12

Title

Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)

Description

Time Frame

Baseline, Week 12

Title

Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)

Description

Time Frame

Baseline, Week 12

Title

Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)

Description

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit. Male and female subjects ≥ 12 years of age at the time of screening. CSU diagnosis for ≥ 6 months. Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following: The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1) Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14) Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. Key Exclusion Criteria: History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies). Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria. Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency). Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen. Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.). Prior exposure to ligelizumab or omalizumab. H1-AH used as background medication at greater than locally label-approved doses after visit 1

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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

7623

Country

Hungary

Facility Name

Novartis Investigative Site

City

Belagavi

State/Province

Karnataka

ZIP/Postal Code

590010

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422 101

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422005

Country

India

Facility Name

Novartis Investigative Site

City

Navi Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 706

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

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

Bundang Gu

State/Province

Gyeonggi Do

ZIP/Postal Code

13620

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

05505

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

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

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

Ksawerow

State/Province

POL

ZIP/Postal Code

95-054

Country

Poland

Facility Name

Novartis Investigative Site

City

Kielce

ZIP/Postal Code

25-155

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-530

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-080

Country

Poland

Facility Name

Novartis Investigative Site

City

Rzeszow

ZIP/Postal Code

35 055

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

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

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

193231

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

229899

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308205

Country

Singapore

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

Malaga

State/Province

Andalucia

ZIP/Postal Code

29009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

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

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Malmo

ZIP/Postal Code

SE-205 02

Country

Sweden

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

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

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

Gaziantep

ZIP/Postal Code

27310

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1511

Description

A Plain Language Trial Summary is available on novctrd.com.

Learn more about this trial

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

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A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Chronic Spontaneous Urticaria

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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