Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Chronic Spontaneous Urticaria Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477332
• Other study ID #: CQGE031C2201
• Secondary ID: 2014-005559-16
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2015
• Est. completion date: June 12, 2017

Study information

• Verified date: October 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: June 12, 2017
• Est. primary completion date: November 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of chronic spontaneous urticaria for at least 6 months

• Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclusion Criteria:

• Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria

• Evidence of parasitic infection

• Any other skin disease with chronic itching

• Previous treatment with omalizumab or QGE031

• Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine

• History of anaphylaxis

• History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study

• History of hypersensitivity to any of the study drugs or its components of similar chemical classes

• Pregnant or nursing (lactating) women

Other protocol defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Urticaria

Intervention

Biological:
• QGE031

• Omalizumab

Other:
• Placebo

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Campbelltown	New South Wales
Australia	Novartis Investigative Site	East Melbourne	Victoria
Australia	Novartis Investigative Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Woolloongabba	Queensland
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenster
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Haidari Athens
Japan	Novartis Investigative Site	Hiroshima city	Hiroshima
Japan	Novartis Investigative Site	Kamimashi-gun	Kumamoto
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Machida-city	Tokyo
Japan	Novartis Investigative Site	Obihiro-city	Hokkaido
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Saitama-city	Saitama
Japan	Novartis Investigative Site	Sakai	Osaka
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan	Tatarstan Republic
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St.-Petersburg
Spain	Novartis Investigative Site	Alcorcon	Madrid
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Pozuelo de Alarcon	Madrid
Spain	Novartis Investigative Site	Sant Joan Despi	Barcelona
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Tao-Yuan
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Yeovil	Somerset
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Forest Hills	New York
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Katy	Texas
United States	Novartis Investigative Site	Lake Oswego	Oregon
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mission Viejo	California
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Providence	Rhode Island
United States	Novartis Investigative Site	Rochester	Minnesota
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	South Burlington	Vermont
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Waldorf	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Greece,  Japan,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Complete Hives Response (HSS7=0)	The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).; Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.; Hives Severity Score scale: 0 - None; - Mild (1-6 hives/12 hours); - Moderate (7-12 hives/12 hours); - Severe (>12 hives/12 hours); To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.	Week 12
Secondary	Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days	Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) 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.; Complete hives response defined as HSS7 = 0.; Hives Severity Score scale: 0 - None; - Mild (1-6 hives/12 hours); - Moderate (7-12 hives/12 hours); - Severe (>12 hives/12 hours)	Week 12
Secondary	Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days	Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) 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.; Hives Severity Score scale: 0 - None; - Mild (1-6 hives/12 hours); - Moderate (7-12 hives/12 hours); - Severe (>12 hives/12 hours)	Week 12
Secondary	HSS7=0 Response: at Week 20 Measured Over 7 Days	Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) 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.; Complete hives response defined as HSS7 = 0.; Hives Severity Score scale: 0 - None; - Mild (1-6 hives/12 hours); - Moderate (7-12 hives/12 hours); - Severe (>12 hives/12 hours)	Week 20
Secondary	Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days	Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) 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.; Hives Severity Score scale: 0 - None; - Mild (1-6 hives/12 hours); - Moderate (7-12 hives/12 hours); - Severe (>12 hives/12 hours)	Week 20
Secondary	Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days	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; - Mild (minimal awareness, easily tolerated); - Moderate (definite awareness, bothersome but tolerable); - Severe (difficult to tolerate)	Week 12
Secondary	Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days	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; - Mild (minimal awareness, easily tolerated); - Moderate (definite awareness, bothersome but tolerable); - Severe (difficult to tolerate)	Week 20
Secondary	Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.	Week 12
Secondary	Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.	Week 20
Secondary	Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.; Complete urticaria activity response is defined as UAS7 = 0.	Week 12
Secondary	UAS7=0 Response: at Week 20 Measured Over 7 Days	UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.; Complete urticaria activity response is defined as UAS7 = 0.	Week 20
Secondary	Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days	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.; Complete itch response defined as ISS7 = 0.; Itch Severity Score scale: 0 - None; - Mild (minimal awareness, easily tolerated); - Moderate (definite awareness, bothersome but tolerable); - Severe (difficult to tolerate)	Week 12
Secondary	ISS7=0 Response: at Week 20 Measured Over 7 Days	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.; Complete itch response defined as ISS7 = 0.; Itch Severity Score scale: 0 - None; - Mild (minimal awareness, easily tolerated); - Moderate (definite awareness, bothersome but tolerable); - Severe (difficult to tolerate)	Week 20

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com