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

NCT02477332 — Phase 2, Completed, 382 participants, Novartis Pharmaceuticals

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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)

Registry	NCT02477332
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	382 (Actual)
Sponsor	Novartis Pharmaceuticals (Industry)
Conditions	Chronic Spontaneous Urticaria
Interventions	QGE031, Omalizumab, Placebo (Biological, other)
Dates	start 2015-07-15, primary completion 2016-11-02, completion 2017-06-12, first posted 2015-06-22, last updated 2021-01-05
Locations	82 sites in United States, Australia, Canada, Germany, Greece, Japan, Russia, Spain and 2 more countries

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
QGE031 24 mg s.c. q4w	Experimental	Biological: QGE031	ligelizumab 24 mg injection subcutaneous every 4 weeks
QGE031 72 mg s.c. q4w	Experimental	Biological: QGE031	ligelizumab 72 mg injection subcutaneous every 4 weeks
QGE031 240 mg s.c. q4w	Experimental	Biological: QGE031	ligelizumab 240 mg injection subcutaneous every 4 weeks
Omalizumab 300 mg s.c. q4w	Active comparator	Biological: Omalizumab	omalizumab 300 mg injection subcutaneous every 4 weeks
Placebo s.c. q4w	Placebo comparator	Other: Placebo	placebo injection subcutaneous every 4 weeks
QGE031 120 mg s.c. s.d.	Experimental	Biological: QGE031	ligelizumab 120 mg injection subcutaneous single dose

QGE031 (Biological)
Omalizumab (Biological)
Placebo (Other)

+Outcome measures

Primary outcomes

Percentage of Participants With Complete Hives Response (HSS7=0) [Week 12]: 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 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- 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.

Secondary outcomes

Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days [Week 12]: 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 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (>12 hives/12 hours)
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days [Week 12]: 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 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (>12 hives/12 hours)
HSS7=0 Response: at Week 20 Measured Over 7 Days [Week 20]: 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 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (>12 hives/12 hours)
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days [Week 20]: 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 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (>12 hives/12 hours)
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days [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)
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days [Week 20]: 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)
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days [Week 12]: UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days [Week 20]: 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 Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days [Week 12]: 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.
UAS7=0 Response: at Week 20 Measured Over 7 Days [Week 20]: 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.
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days [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. Complete itch response defined as ISS7 = 0. Itch Severity Score scale: 0 - None 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (definite awareness, bothersome but tolerable) 3. \- Severe (difficult to tolerate)
ISS7=0 Response: at Week 20 Measured Over 7 Days [Week 20]: 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 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (definite awareness, bothersome but tolerable) 3. \- Severe (difficult to tolerate)

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Posted results

Participant flow

Milestone	QGE031 24 mg s.c. q4w	QGE031 72 mg s.c. q4w	QGE031 240 mg s.c. q4w	Omalizumab 300 mg s.c. q4w	Placebo s.c. q4w	QGE031 120 mg s.c. s.d.
Started	43	84	85	85	43	42
Completed	40	77	73	72	39	37
Not completed	3	7	12	13	4	5

Outcome results

Percentage of Participants With Complete Hives Response (HSS7=0) (Primary), Number, Percentage of participants: QGE031 24 mg s.c. q4w 30.2 (17.2 to 46.1); QGE031 72 mg s.c. q4w 51.2 (40.0 to 62.3); QGE031 240 mg s.c. q4w 42.4 (31.7 to 53.6); Omalizumab 300 mg s.c. q4w 25.9 (17.0 to 36.5); Placebo s.c. q4w 0 (0.0 to 8.2); QGE031 120 mg s.c. s.d. 19.0 (8.6 to 34.1) (p <.05)
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days (Secondary), Number, Particpants: QGE031 24 mg s.c. q4w 13; QGE031 72 mg s.c. q4w 43; QGE031 240 mg s.c. q4w 36; Omalizumab 300 mg s.c. q4w 22; Placebo 0
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days (Secondary), Median, Score on a scale: QGE031 24 mg s.c. q4w -9.75 (-15.75 to -2.50); QGE031 72 mg s.c. q4w -15.50 (-20.00 to -6.00); QGE031 240 mg s.c. q4w -13.50 (-19.00 to -9.00); Omalizumab 300 mg s.c. q4w -11.00 (-16.50 to -4.50); Placebo -6.50 (-13.00 to -2.33)
HSS7=0 Response: at Week 20 Measured Over 7 Days (Secondary), Number, Participants: QGE031 24 mg s.c. q4w 11; QGE031 72 mg s.c. q4w 43; QGE031 240 mg s.c. q4w 38; Omalizumab 300 mg s.c. q4w 29; Placebo 4
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days (Secondary), Median, Score on a scale: QGE031 24 mg s.c. q4w -9.00 (-12.50 to -3.50); QGE031 72 mg s.c. q4w -16.50 (-20.50 to -6.83); QGE031 240 mg s.c. q4w -14.00 (-19.50 to -9.00); Omalizumab 300 mg s.c. q4w -11.00 (-16.00 to -4.25); Placebo -7.50 (-13.50 to -2.25)
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days (Secondary), Median, Score on a scale: QGE031 24 mg s.c. q4w -7.50 (-12.75 to -3.50); QGE031 72 mg s.c. q4w -9.50 (-14.50 to -6.00); QGE031 240 mg s.c. q4w -9.00 (-14.00 to -4.50); Omalizumab 300 mg s.c. q4w -8.00 (-11.50 to -4.50); Placebo -5.50 (-8.50 to -2.50)
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days (Secondary), Median, Score on a scale: QGE031 24 mg s.c. q4w -7.00 (-11.00 to -2.00); QGE031 72 mg s.c. q4w -10.25 (-14.00 to -6.50); QGE031 240 mg s.c. q4w -10.00 (-14.00 to -5.50); Omalizumab 300 mg s.c. q4w -8.83 (-11.50 to -3.50); Placebo -5.00 (-9.50 to -2.25)
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days (Secondary), Median, Score on a scale: QGE031 24 mg s.c. q4w -19.50 (-26.75 to -6.25); QGE031 72 mg s.c. q4w -26.50 (-33.00 to -12.00); QGE031 240 mg s.c. q4w -21.75 (-32.50 to -14.00); Omalizumab 300 mg s.c. q4w -19.00 (-29.00 to -8.50); Placebo -12.00 (-21.00 to -6.00)
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days (Secondary), Median, Score on a scale: QGE031 24 mg s.c. q4w -16.00 (-23.00 to -7.00); QGE031 72 mg s.c. q4w -27.00 (-33.00 to -15.00); QGE031 240 mg s.c. q4w -22.92 (-32.50 to -13.50); Omalizumab 300 mg s.c. q4w -18.50 (-28.50 to -11.00); Placebo -13.00 (-21.00 to -5.50)
Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days (Secondary), Number, Participants: QGE031 24 mg s.c. q4w 13; QGE031 72 mg s.c. q4w 37; QGE031 240 mg s.c. q4w 34; Omalizumab 300 mg s.c. q4w 22; Placebo 0
UAS7=0 Response: at Week 20 Measured Over 7 Days (Secondary), Number, participants: QGE031 24 mg s.c. q4w 8; QGE031 72 mg s.c. q4w 33; QGE031 240 mg s.c. q4w 34; Omalizumab 300 mg s.c. q4w 26; Placebo 2
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days (Secondary), Number, participants: QGE031 24 mg s.c. q4w 17; QGE031 72 mg s.c. q4w 40; QGE031 240 mg s.c. q4w 36; Omalizumab 300 mg s.c. q4w 25; Placebo 2
ISS7=0 Response: at Week 20 Measured Over 7 Days (Secondary), Number, participants: QGE031 24 mg s.c. q4w 8; QGE031 72 mg s.c. q4w 35; QGE031 240 mg s.c. q4w 36; Omalizumab 300 mg s.c. q4w 28; Placebo 3

Adverse events

Time frame: Through study completion, an average of 44 weeks.

Arm	Deaths	Serious adverse events	Other adverse events
QGE031 24 mg s.c. q4w	0/43 (0.0%)	3/43 (7.0%)	24/43 (55.8%)
QGE031 72 mg s.c. q4w	0/84 (0.0%)	2/84 (2.4%)	45/84 (53.6%)
QGE031 240 mg s.c. q4w	0/85 (0.0%)	2/85 (2.4%)	46/85 (54.1%)
Omalizumab 300 mg s.c. q4w	0/85 (0.0%)	3/85 (3.5%)	44/85 (51.8%)
Placebo s.c. q4w	0/43 (0.0%)	4/43 (9.3%)	30/43 (69.8%)
QGE031 120 mg s.c. s.d.	0/42 (0.0%)	4/42 (9.5%)	28/42 (66.7%)

Serious adverse events by term

Term	Organ system	QGE031 24 mg s.c. q4w	QGE031 72 mg s.c. q4w	QGE031 240 mg s.c. q4w	Omalizumab 300 mg s.c. q4w	Placebo s.c. q4w	QGE031 120 mg s.c. s.d.
Angina pectoris	Cardiac disorders	0/43	0/84	0/85	0/85	1/43	0/42
Abdominal distension	Gastrointestinal disorders	0/43	0/84	0/85	0/85	1/43	0/42
Abdominal pain	Gastrointestinal disorders	0/43	0/84	0/85	0/85	1/43	0/42
Colon dysplasia	Gastrointestinal disorders	0/43	0/84	1/85	0/85	0/43	0/42
Diverticular perforation	Gastrointestinal disorders	1/43	0/84	0/85	0/85	0/43	0/42
Inguinal hernia	Gastrointestinal disorders	0/43	0/84	0/85	0/85	0/43	1/42
Large intestine polyp	Gastrointestinal disorders	0/43	0/84	1/85	0/85	0/43	0/42
Subileus	Gastrointestinal disorders	0/43	0/84	0/85	1/85	0/43	0/42
Chest pain	General disorders	0/43	0/84	0/85	0/85	1/43	0/42
Cholelithiasis	Hepatobiliary disorders	0/43	0/84	0/85	0/85	1/43	0/42
Hepatic cyst	Hepatobiliary disorders	0/43	0/84	0/85	0/85	1/43	0/42
Hepatitis acute	Hepatobiliary disorders	1/43	0/84	0/85	0/85	0/43	0/42
Diverticulitis	Infections and infestations	1/43	0/84	0/85	0/85	0/43	0/42
Pilonidal cyst	Infections and infestations	0/43	0/84	1/85	0/85	0/43	0/42
Pneumonia	Infections and infestations	1/43	0/84	0/85	0/85	0/43	1/42
Fractured coccyx	Injury, poisoning and procedural complications	0/43	1/84	0/85	0/85	0/43	0/42
Radius fracture	Injury, poisoning and procedural complications	0/43	0/84	0/85	1/85	0/43	0/42
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	0/43	0/84	0/85	0/85	1/43	0/42
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	1/43	0/84	0/85	0/85	0/43	0/42
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0/43	0/84	0/85	0/85	0/43	1/42
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0/43	0/84	0/85	0/85	0/43	1/42
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0/43	1/84	0/85	0/85	0/43	0/42
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0/43	0/84	0/85	0/85	1/43	0/42
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0/43	0/84	0/85	0/85	1/43	0/42
Angioedema	Skin and subcutaneous tissue disorders	1/43	0/84	0/85	0/85	0/43	0/42
Prurigo	Skin and subcutaneous tissue disorders	0/43	0/84	0/85	1/85	0/43	0/42
Urticaria	Skin and subcutaneous tissue disorders	1/43	0/84	0/85	0/85	0/43	0/42

Other adverse events by term

Term	Organ system	QGE031 24 mg s.c. q4w	QGE031 72 mg s.c. q4w	QGE031 240 mg s.c. q4w	Omalizumab 300 mg s.c. q4w	Placebo s.c. q4w	QGE031 120 mg s.c. s.d.
Diarrhoea	Gastrointestinal disorders	2/43	4/84	5/85	6/85	2/43	2/42
Gastritis	Gastrointestinal disorders	0/43	0/84	0/85	0/85	0/43	3/42
Nausea	Gastrointestinal disorders	1/43	1/84	2/85	5/85	2/43	1/42
Injection site erythema	General disorders	0/43	2/84	5/85	0/85	0/43	1/42
Injection site reaction	General disorders	0/43	3/84	6/85	0/85	1/43	0/42
Bronchitis	Infections and infestations	1/43	1/84	0/85	5/85	1/43	0/42
Influenza	Infections and infestations	1/43	4/84	4/85	5/85	1/43	1/42
Upper respiratory tract infection	Infections and infestations	7/43	7/84	10/85	10/85	6/43	9/42
Urinary tract infection	Infections and infestations	0/43	5/84	4/85	5/85	0/43	2/42
Viral upper respiratory tract infection	Infections and infestations	7/43	13/84	17/85	17/85	13/43	10/42
Blood creatinine increased	Investigations	1/43	3/84	3/85	2/85	4/43	1/42
Arthralgia	Musculoskeletal and connective tissue disorders	1/43	6/84	1/85	2/85	1/43	1/42
Back pain	Musculoskeletal and connective tissue disorders	0/43	1/84	0/85	1/85	1/43	3/42
Dizziness	Nervous system disorders	2/43	5/84	2/85	2/85	4/43	0/42
Headache	Nervous system disorders	7/43	9/84	7/85	12/85	7/43	1/42
Eczema	Skin and subcutaneous tissue disorders	1/43	5/84	4/85	2/85	1/43	3/42
Urticaria	Skin and subcutaneous tissue disorders	1/43	9/84	3/85	4/85	5/43	7/42
Hypertension	Vascular disorders	1/43	5/84	2/85	2/85	3/43	3/42

+Locations (82)

Facility	City	Country
Novartis Investigative Site	Birmingham, Alabama	United States
Novartis Investigative Site	Scottsdale, Arizona	United States
Novartis Investigative Site	Little Rock, Arkansas	United States
Novartis Investigative Site	Huntington Beach, California	United States
Novartis Investigative Site	Mission Viejo, California	United States
Novartis Investigative Site	Sarasota, Florida	United States
Novartis Investigative Site	Evansville, Indiana	United States
Novartis Investigative Site	Louisville, Kentucky	United States
Novartis Investigative Site	Owensboro, Kentucky	United States
Novartis Investigative Site	Waldorf, Maryland	United States
Novartis Investigative Site	Minneapolis, Minnesota	United States
Novartis Investigative Site	Rochester, Minnesota	United States
Novartis Investigative Site	St Louis, Missouri	United States
Novartis Investigative Site	Forest Hills, New York	United States
Novartis Investigative Site	The Bronx, New York	United States
Novartis Investigative Site	Asheville, North Carolina	United States
Novartis Investigative Site	Cincinnati, Ohio	United States
Novartis Investigative Site	Toledo, Ohio	United States
Novartis Investigative Site	Lake Oswego, Oregon	United States
Novartis Investigative Site	Providence, Rhode Island	United States
Novartis Investigative Site	Dallas, Texas	United States
Novartis Investigative Site	Fort Worth, Texas	United States
Novartis Investigative Site	Katy, Texas	United States
Novartis Investigative Site	South Burlington, Vermont	United States
Novartis Investigative Site	Spokane, Washington	United States
Novartis Investigative Site	Campbelltown, New South Wales	Australia
Novartis Investigative Site	Sydney, New South Wales	Australia
Novartis Investigative Site	Woolloongabba, Queensland	Australia
Novartis Investigative Site	Adelaide, South Australia	Australia
Novartis Investigative Site	East Melbourne, Victoria	Australia
Novartis Investigative Site	Toronto, Ontario	Canada
Novartis Investigative Site	Waterloo, Ontario	Canada
Novartis Investigative Site	Québec	Canada
Novartis Investigative Site	Munich, Bavaria	Germany
Novartis Investigative Site	Berlin	Germany
Novartis Investigative Site	Dresden	Germany
Novartis Investigative Site	Freiburg im Breisgau	Germany
Novartis Investigative Site	Hanover	Germany
Novartis Investigative Site	Mainz	Germany
Novartis Investigative Site	Münster	Germany
Novartis Investigative Site	Haidari Athens, Greece	Greece
Novartis Investigative Site	Athens, GR	Greece
Novartis Investigative Site	Athens	Greece
Novartis Investigative Site	Hiroshima, Hiroshima	Japan
Novartis Investigative Site	Obihiro, Hokkaido	Japan
Novartis Investigative Site	Kobe, Hyōgo	Japan
Novartis Investigative Site	Yokohama, Kanagawa	Japan
Novartis Investigative Site	Kamimashi-gun, Kumamoto	Japan
Novartis Investigative Site	Kyoto, Kyoto	Japan
Novartis Investigative Site	Sakai, Osaka	Japan
Novartis Investigative Site	Saitama, Saitama	Japan
Novartis Investigative Site	Machida, Tokyo	Japan
Novartis Investigative Site	Ōta-ku, Tokyo	Japan
Novartis Investigative Site	Shinagawa-ku, Tokyo	Japan
Novartis Investigative Site	Kazan', Tatarstan Republic	Russia
Novartis Investigative Site	Chelyabinsk	Russia
Novartis Investigative Site	Moscow	Russia
Novartis Investigative Site	Moscow	Russia
Novartis Investigative Site	Saint Petersburg	Russia
Novartis Investigative Site	Saint Petersburg	Russia
Novartis Investigative Site	Smolensk	Russia
Novartis Investigative Site	Córdoba, Andalusia	Spain
Novartis Investigative Site	Málaga, Andalusia	Spain
Novartis Investigative Site	Seville, Andalusia	Spain
Novartis Investigative Site	Sant Joan Despí, Barcelona	Spain
Novartis Investigative Site	Barcelona, Catalonia	Spain
Novartis Investigative Site	Barcelona, Catalonia	Spain
Novartis Investigative Site	Barcelona, Catalonia	Spain
Novartis Investigative Site	A Coruña, Galicia	Spain
Novartis Investigative Site	Alcorcón, Madrid	Spain
Novartis Investigative Site	Pozuelo de Alarcón, Madrid	Spain
Novartis Investigative Site	Alicante, Valencia	Spain
Novartis Investigative Site	Valencia, Valencia	Spain
Novartis Investigative Site	Barcelona	Spain
Novartis Investigative Site	Madrid	Spain
Novartis Investigative Site	Madrid	Spain
Novartis Investigative Site	Taoyuan, Taiwan	Taiwan
Novartis Investigative Site	Taichung	Taiwan
Novartis Investigative Site	Taipei	Taiwan
Novartis Investigative Site	Yeovil, Somerset	United Kingdom
Novartis Investigative Site	Leeds	United Kingdom
Novartis Investigative Site	London	United Kingdom

+Publications

Results publication: Metz M, Bernstein JA, Gimenez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. doi: 10.1016/j.waojou.2022.100716. eCollection 2022 Nov. PMID 36440464
Results publication: Maurer M, Gimenez-Arnau A, Bernstein JA, Chu CY, Danilycheva I, Hide M, Makris M, Metz M, Savic S, Sitz K, Soong W, Staubach P, Sussman G, Barve A, Burciu A, Hua E, Janocha R, Severin T. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. Allergy. 2022 Jul;77(7):2175-2184. doi: 10.1111/all.15175. Epub 2021 Nov 22. PMID 34773261
Results publication: Maurer M, Gimenez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, Bernstein JA, Brehler R, Chu CY, Chung WH, Danilycheva I, Grattan C, Hebert J, Katelaris C, Makris M, Meshkova R, Savic S, Sinclair R, Sitz K, Staubach P, Wedi B, Loffler J, Barve A, Kobayashi K, Hua E, Severin T, Janocha R. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019 Oct 3;381(14):1321-1332. doi: 10.1056/NEJMoa1900408. PMID 31577874

+Investigators

Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals

+Funding

NIH grants: 2014