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This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Primary Purpose

Chronic Spontaneous Urticaria

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LOU064 Arm 1

LOU064 Arm 2

LOU064 Arm 3

LOU064 Arm 4

LOU064 Arm 5

LOU064 Arm 6

Placebo arm

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring BTK inhibitor, Urticaria Activity Score, Angioedema Activity Score, CSU

Eligibility Criteria

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

Inclusion Criteria:

Male and female subjects aged ≥18 years of age
CSU diagnosis for ≥ 6 months prior to screening
Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period
UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1)
Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study

Exclusion Criteria:

Hypersensitivity to any of the study treatments
Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
Other diseases with symptoms of urticaria or angioedema
Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results,
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.
Pregnant or nursing (lactating) women
Women of child-bearing potential not using highly effective methods of contraception

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Arm Label

LOU064 Arm 1

LOU064 Arm 2

LOU064 Arm 3

LOU064 Arm 4

LOU064 Arm 5

LOU064 Arm 6

Placebo Arm

Arm Description

10 mg LOU064 qd capsule once daily

35 mg capsule qd LOU064 once daily

100 mg capsule qd LOU064 once daily

10 mg capsule LOU064 bid

25 mg capsule LOU064 bid

100 mg capsule LOU064 bid

Participants took matching placebo twice daily

Outcomes

Primary Outcome Measures

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4

UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) 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. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.

Secondary Outcome Measures

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

UAS7 score change (LS mean Change) from baseline at Week 12 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)

Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6)

UAS7=0 and UAS7<=6 response rate over time by treatment group (non-responder imputation) 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. The maximum UAS7 value is 42. A higher score indicates more severe disease. A negative change score (week 4 score minus Baseline score) indicates improvement.

Cumulative Number of Weeks With an AAS7=0 Response

The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reports the occurrence of angioedema ("opening question") with "no", AAS score for this day is 0. If "yes" is the answer to the opening question, the subject will continue to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105. Higher score means more severe disease.

Percentage of Participants With DLQI Score of 0 or 1

Percentage of subjects with DLQI 0/1 response by treatment group and visit (non-responder imputation) The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate 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 is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.

Mean Change From Baseline in DLQI Score

Summary of DLQI score and change from baseline The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate 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 is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL).

Area Under the Blood Concentration-time Curve (AUC) of LOU064

Assessment of the area under the blood concentration-time curve (AUC) up to four hours following oral administration at Week 4 and Week 12 .

Observed Maximum Blood Concentration (Cmax) of LOU064

Assessment of the observed maximum blood concentration (Cmax) of LOU064 following drug administration at Week 4 and Week 12 .

Time to Reach the Maximum Concentration (Tmax) of LOU064

Assessment of the time to reach the maximum concentration (Tmax) of LOU064 following drug administration at Weeks 4 and 12

Full Information

NCT ID

NCT03926611

First Posted

April 12, 2019

Last Updated

April 27, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03926611

Brief Title

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Official Title

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

June 6, 2019 (Actual)

Primary Completion Date

January 14, 2021 (Actual)

Study Completion Date

April 15, 2021 (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

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Detailed Description

This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebo-controlled study investigating the efficacy, safety and tolerability of six dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10 mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d., LOU064 100 mg b.i.d. and placebo.

6. Conditions and Keywords

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

Chronic Spontaneous Urticaria

Keywords

BTK inhibitor, Urticaria Activity Score, Angioedema Activity Score, CSU

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebocontrolled study investigating the efficacy, safety and tolerability of 6 dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. Study duration was 18 weeks (2 weeks of screening period; 12 weeks of treatment period and a 4 weeks follow-up period). Study had 7 arms: 10 mg LOU064 q.d.; 35 mg LOU064 q.d.; 100 mg LOU064 q.d.; 10 mg LOU064 b.i.d.; 25 mg LOU064 b.i.d.; 100 mg LOU064 b.i.d.; and Placebo Throughout study, subjects were treated with a 2nd generation H1-antihistamine at a locally approved licensed posology ("background medication"). Subjects could take an additional second generation H1-antihistamine that was eliminated primarily via renal excretion (e.g. cetirizine, levocetirizine or bilastine) as rescue medication. Eligible subjects could roll over to extension at Wk 12 or Wk 16

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

311 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LOU064 Arm 1

Arm Type

Experimental

Arm Description

10 mg LOU064 qd capsule once daily

Arm Title

LOU064 Arm 2

Arm Type

Experimental

Arm Description

35 mg capsule qd LOU064 once daily

Arm Title

LOU064 Arm 3

Arm Type

Experimental

Arm Description

100 mg capsule qd LOU064 once daily

Arm Title

LOU064 Arm 4

Arm Type

Experimental

Arm Description

10 mg capsule LOU064 bid

Arm Title

LOU064 Arm 5

Arm Type

Experimental

Arm Description

25 mg capsule LOU064 bid

Arm Title

LOU064 Arm 6

Arm Type

Experimental

Arm Description

100 mg capsule LOU064 bid

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

Participants took matching placebo twice daily

Intervention Type

Drug

Intervention Name(s)

LOU064 Arm 1

Intervention Description

10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

Intervention Type

Drug

Intervention Name(s)

LOU064 Arm 2

Intervention Description

35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

Intervention Type

Drug

Intervention Name(s)

LOU064 Arm 3

Intervention Description

100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

Intervention Type

Drug

Intervention Name(s)

LOU064 Arm 4

Intervention Description

10mg bid of LOU064 orally, twice daily from Day 1 to 85

Intervention Type

Drug

Intervention Name(s)

LOU064 Arm 5

Intervention Description

25 mg bid of LOU064 orally, twice daily from Day 1 to 85

Intervention Type

Drug

Intervention Name(s)

LOU064 Arm 6

Intervention Description

100 mg bid of LOU064 orally, twice daily from Day 1 to 85

Intervention Type

Drug

Intervention Name(s)

Placebo arm

Intervention Description

Matching placebo, orally, twice daily from Day 1 to 85

Primary Outcome Measure Information:

Title

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4

Description

Time Frame

Baseline, Week 4

Secondary Outcome Measure Information:

Title

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

Description

UAS7 score change (LS mean Change) from baseline at Week 12 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)

Time Frame

Week 12

Title

Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6)

Description

Time Frame

Week 12

Title

Cumulative Number of Weeks With an AAS7=0 Response

Description

Time Frame

Baseline to Week 12

Title

Percentage of Participants With DLQI Score of 0 or 1

Description

Time Frame

Week 4 and Week 12

Title

Mean Change From Baseline in DLQI Score

Description

Time Frame

Baseline, Week 4 and Week 12

Title

Area Under the Blood Concentration-time Curve (AUC) of LOU064

Description

Assessment of the area under the blood concentration-time curve (AUC) up to four hours following oral administration at Week 4 and Week 12 .

Time Frame

Week 4 and Week 12

Title

Observed Maximum Blood Concentration (Cmax) of LOU064

Description

Assessment of the observed maximum blood concentration (Cmax) of LOU064 following drug administration at Week 4 and Week 12 .

Time Frame

Week 4 and Week 12

Title

Time to Reach the Maximum Concentration (Tmax) of LOU064

Description

Assessment of the time to reach the maximum concentration (Tmax) of LOU064 following drug administration at Weeks 4 and 12

Time Frame

Week 4 and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects aged ≥18 years of age CSU diagnosis for ≥ 6 months prior to screening Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1) Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study Exclusion Criteria: Hypersensitivity to any of the study treatments Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) Other diseases with symptoms of urticaria or angioedema Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, 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. Pregnant or nursing (lactating) women Women of child-bearing potential not using highly effective methods of contraception

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

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

Westminster

State/Province

California

ZIP/Postal Code

92683

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

Pierre Benite Cedex

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

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Debrecen

State/Province

Hajdu Bihar

ZIP/Postal Code

4026

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

Oroshaza

ZIP/Postal Code

5900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

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

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

Koto

State/Province

Tokyo

ZIP/Postal Code

136-0074

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

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3584CX

Country

Netherlands

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

Wroclaw

ZIP/Postal Code

50-566

Country

Poland

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194325

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

Undecided

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

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1033

Description

A Plain Language Trial Summary is available on novctrd.com

Learn more about this trial

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

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This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Chronic Spontaneous Urticaria

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

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