Chronic Spontaneous UrticariaPhase 2NCT02477332

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

A Phase 2 study testing QGE031 and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 82 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Spontaneous Urticaria
What is being tested?: QGE031 and Omalizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 382 participants
Where: 82 sitesin 10 countries
Study dates: 15 Jul 2015to 12 Jun 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of chronic spontaneous urticaria for at least 6 months
Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

82 sites in 10 countries.

Country

City, postcode or hospital

82 sites in 10 countries

United States25 sites

Novartis Investigative Site
Asheville, North Carolina, 28801
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Evansville, Indiana, 47713
Novartis Investigative Site
Forest Hills, New York, 11375
Novartis Investigative Site
Fort Worth, Texas, 76132
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Katy, Texas, 77450
Novartis Investigative Site
Lake Oswego, Oregon, 97035
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Louisville, Kentucky, 40291
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Providence, Rhode Island, 02906
Novartis Investigative Site
Rochester, Minnesota, 55905
Novartis Investigative Site
Sarasota, Florida, 34233
Novartis Investigative Site
Scottsdale, Arizona, 85251
Novartis Investigative Site
South Burlington, Vermont, 05403
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
The Bronx, New York, 10461
Novartis Investigative Site
Toledo, Ohio, 43617
Novartis Investigative Site
Waldorf, Maryland, 20602

Other trials in United States

Spain15 sites

Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Alcorcón, Madrid, 28922
Novartis Investigative Site
Alicante, Valencia, 03010
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Málaga, Andalusia, 29009
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223
Novartis Investigative Site
Sant Joan Despí, Barcelona, 08970
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Valencia, Valencia, 46015

Other trials in Spain

Japan11 sites

Novartis Investigative Site
Hiroshima, Hiroshima, 734-8551
Novartis Investigative Site
Kamimashi-gun, Kumamoto, 861-3101
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Kyoto, Kyoto, 602-8566
Novartis Investigative Site
Machida, Tokyo, 194-0013
Novartis Investigative Site
Obihiro, Hokkaido, 080-0013
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023
Novartis Investigative Site
Saitama, Saitama, 330-0854
Novartis Investigative Site
Sakai, Osaka, 593-8324
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141 8625
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825

Other trials in Japan

Germany7 sites

Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Munich, Bavaria, 80802
Novartis Investigative Site
Münster, 48149

Other trials in Germany

Russia7 sites

Novartis Investigative Site
Chelyabinsk, 454092
Novartis Investigative Site
Kazan', Tatarstan Republic, 420012
Novartis Investigative Site
Moscow, 107076
Novartis Investigative Site
Moscow, 115478
Novartis Investigative Site
Saint Petersburg, 194223
Novartis Investigative Site
Saint Petersburg, 195112
Novartis Investigative Site
Smolensk, 214019

Other trials in Russia

Australia5 sites

Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Campbelltown, New South Wales, 2560
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Sydney, New South Wales, 2010
Novartis Investigative Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Canada3 sites

Novartis Investigative Site
Québec, G1V 4W2
Novartis Investigative Site
Toronto, Ontario, M4V 1R2
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4

Other trials in Canada

Greece3 sites

Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 11527
Novartis Investigative Site
Haidari Athens, Greece, 12462

Other trials in Greece

Taiwan3 sites

Novartis Investigative Site
Taichung, 407
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taoyuan, Taiwan, 333

Other trials in Taiwan

United Kingdom3 sites

Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

About this study

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)

Conditions: Chronic Spontaneous Urticaria
Being tested: QGE031, Omalizumab, Placebo
Keywords: QGE031, ligelizumab, omalizumab, chronic, spontaneous, urticaria, adults, CSU
Medical subject headings: Chronic Urticaria, Bronchiolitis Obliterans Syndrome, Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QGE031Biological
OmalizumabBiological
PlaceboOther

Study groups in NCT02477332
Study group	Role	What they receive
QGE031 24 mg s.c. q4w	Experimental	ligelizumab 24 mg injection subcutaneous every 4 weeks Receives: Biological: QGE031
QGE031 72 mg s.c. q4w	Experimental	ligelizumab 72 mg injection subcutaneous every 4 weeks Receives: Biological: QGE031
QGE031 240 mg s.c. q4w	Experimental	ligelizumab 240 mg injection subcutaneous every 4 weeks Receives: Biological: QGE031
Omalizumab 300 mg s.c. q4w	Active comparator	omalizumab 300 mg injection subcutaneous every 4 weeks Receives: Biological: Omalizumab
Placebo s.c. q4w	Placebo comparator	placebo injection subcutaneous every 4 weeks Receives: Other: Placebo
QGE031 120 mg s.c. s.d.	Experimental	ligelizumab 120 mg injection subcutaneous single dose Receives: Biological: QGE031

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: Week 12

Secondary outcomes (12)

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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - Severe (>12 hives/12 hours)
Measured: Week 12
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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - Severe (>12 hives/12 hours)
Measured: Week 12
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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - Severe (>12 hives/12 hours)
Measured: Week 20
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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - Severe (>12 hives/12 hours)
Measured: Week 20
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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - Severe (difficult to tolerate)
Measured: Week 12
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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - Severe (difficult to tolerate)
Measured: Week 20
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.
Measured: Week 12
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.
Measured: Week 20
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.
Measured: Week 12
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.
Measured: Week 20
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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - Severe (difficult to tolerate)
Measured: Week 12
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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - Severe (difficult to tolerate)
Measured: Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201512 Jun 2017

First posted22 Jun 2015 (estimated)
Study start15 Jul 2015
Primary completion2 Nov 2016
Study completion12 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02477332
Sponsor's protocol ID: CQGE031C2201
Other IDs: 2014-005559-16, 2014
Status last verified: Oct 2018
First submitted: 11 Jun 2015
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: 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

Publications

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.
PubMed 36440464
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.
PubMed 34773261
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.
PubMed 31577874

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria

All Chronic Spontaneous Urticaria trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02477332
Acronym / sponsor ID: CQGE031C2201
Conditions: Chronic Spontaneous Urticaria
Keywords: QGE031, ligelizumab, omalizumab, chronic, spontaneous, urticaria, adults, CSU
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 382 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 15 Jul 2015 (actual)
Primary completion: 2 Nov 2016 (actual)
Study completion: 12 Jun 2017 (actual)
First posted: 22 Jun 2015 (estimated)
Results: Posted 14 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
QGE031 24 mg s.c. q4w	Experimental	Biological: QGE031ligelizumab 24 mg injection subcutaneous every 4 weeks
QGE031 72 mg s.c. q4w	Experimental	Biological: QGE031ligelizumab 72 mg injection subcutaneous every 4 weeks
QGE031 240 mg s.c. q4w	Experimental	Biological: QGE031ligelizumab 240 mg injection subcutaneous every 4 weeks
Omalizumab 300 mg s.c. q4w	Active comparator	Biological: Omalizumabomalizumab 300 mg injection subcutaneous every 4 weeks
Placebo s.c. q4w	Placebo comparator	Other: Placeboplacebo injection subcutaneous every 4 weeks
QGE031 120 mg s.c. s.d.	Experimental	Biological: QGE031ligelizumab 120 mg injection subcutaneous single dose

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of chronic spontaneous urticaria for at least 6 months
Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QGE031	Biological	QGE031 120 mg s.c. s.d., QGE031 24 mg s.c. q4w, QGE031 240 mg s.c. q4w, QGE031 72 mg s.c. q4w
Omalizumab	Biological	Omalizumab 300 mg s.c. q4w
Placebo	Other	Placebo s.c. q4w

Primary outcome

Percentage of Participants With Complete Hives Response (HSS7=0)
Time frame: 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.

12 secondary outcomes

Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
Time frame: Week 12
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
Time frame: Week 12
HSS7=0 Response: at Week 20 Measured Over 7 Days
Time frame: Week 20
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
Time frame: Week 20
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
Time frame: Week 12
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
Time frame: Week 20
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
Time frame: Week 12
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
Time frame: Week 20
Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
Time frame: Week 12
UAS7=0 Response: at Week 20 Measured Over 7 Days
Time frame: Week 20
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
Time frame: Week 12
ISS7=0 Response: at Week 20 Measured Over 7 Days
Time frame: Week 20

Results and safety

Results posted to the registry on 14 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QGE031 24 mg s.c. q4w	43	40
QGE031 72 mg s.c. q4w	84	77
QGE031 240 mg s.c. q4w	85	73
Omalizumab 300 mg s.c. q4w	85	72
Placebo s.c. q4w	43	39
QGE031 120 mg s.c. s.d.	42	37

Primary outcome: Percentage of Participants With Complete Hives Response (HSS7=0)

Time frame: Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	QGE031 24 mg s.c. q4w n = 43	QGE031 72 mg s.c. q4w n = 84	QGE031 240 mg s.c. q4w n = 85	Omalizumab 300 mg s.c. q4w n = 85	Placebo s.c. q4w n = 43	QGE031 120 mg s.c. s.d. n = 42
Value	30.2 (17.2 to 46.1)	51.2 (40.0 to 62.3)	42.4 (31.7 to 53.6)	25.9 (17.0 to 36.5)	0 (0.0 to 8.2)	19.0 (8.6 to 34.1)

QGE031 24 mg s.c. q4w vs QGE031 72 mg s.c. q4w vs QGE031 240 mg s.c. q4w vs Omalizumab 300 mg s.c. q4w: Estimated target dose: 32.5 (60% CI 27.5 to 42.5), p <.05, Regression, Logistic

Population analysed: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 44 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QGE031 24 mg s.c. q4w	3 of 43 (7%)	24 of 43 (55.8%)	0 of 43
QGE031 72 mg s.c. q4w	2 of 84 (2.4%)	45 of 84 (53.6%)	0 of 84
QGE031 240 mg s.c. q4w	2 of 85 (2.4%)	46 of 85 (54.1%)	0 of 85
Omalizumab 300 mg s.c. q4w	3 of 85 (3.5%)	44 of 85 (51.8%)	0 of 85
Placebo s.c. q4w	4 of 43 (9.3%)	30 of 43 (69.8%)	0 of 43
QGE031 120 mg s.c. s.d.	4 of 42 (9.5%)	28 of 42 (66.7%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36440464Metz 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.
Derived from this study: PubMed 34773261Maurer 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.
Derived from this study: PubMed 31577874Maurer 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.
A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

82 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QGE031 and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 82 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Spain, Japan, Germany, Russia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete Hives Response (HSS7=0) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477332, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.