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Chronic Spontaneous UrticariaPhase 2NCT02649218

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

A Phase 2 study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 67 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

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201 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?
Ligelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
67 sitesin 10 countries
Study dates
24 May 2016to 2 May 2019
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

  • Patients eligible for inclusion in this study have to fulfill all of the following criteria:
  • Written informed consent must be obtained before any assessment is performed.
  • Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥12.
  • Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
  • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Who cannot join

  • Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
  • Evidence of parasitic infection
  • Any other skin diseases than chronic spontaneous urticaria with chronic itching
  • 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

Trial locations and contacts

67 sites in 10 countries.

67 sites in 10 countries

United States17 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

    Fort Worth, Texas, 76132

  • Novartis Investigative Site

    Lake Oswego, Oregon, 97035

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • 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

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Toledo, Ohio, 43617

  • Novartis Investigative Site

    Waldorf, Maryland, 20602

Other trials in United States

Spain12 sites

  • 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

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Valencia, Valencia, 46015

Other trials in Spain

Japan11 sites

  • Novartis Investigative Site

    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, 13353

  • 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, 80377

  • Novartis Investigative Site

    Münster, 48149

Other trials in Germany

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

Russia5 sites

  • Novartis Investigative Site

    Chelyabinsk, 454092

  • 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

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, 115 27

  • Novartis Investigative Site

    Athens, 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 Kingdom1 site

  • Novartis Investigative Site

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

About this study

Official title: An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

Read the detailed description

A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients

Being tested
Ligelizumab
Keywords
QGE031, chronic, spontaneous, Urticaria, CSU, adults, Safety, ligelizumab
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.

  • LigelizumabBiological

    Also called QGE031

    QGE031 240 mg s.c. q4w

Study groups in NCT02649218
Study groupRoleWhat they receive
LigelizumabExperimentalQGE031 240 mg s.c. q4w x 13 treatments
Receives: Biological: Ligelizumab

What is being measured

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

  1. Number of Participants With at Least One Treatment Emergent Adverse Event (AE)

    The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.

    Measured: Within 16 weeks after Week 48

Secondary outcomes (2)

  1. Percentage of Subjects Having Achieved UAS7 ≤ 6

    The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations:

    Sustained remission defined as maintaining (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.

    Measured: Baseline, Week 52 and Week 100

  2. Number and Proportion of Participants Who Achieved UAS7≤ 6

    Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100).

    Measured: Baseline, Week 52, Week 100

Timeline

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

  1. First posted7 Jan 2016 (estimated)
  2. Study start24 May 2016
  3. Primary completion2 May 2019
  4. Study completion2 May 2019

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649218
Sponsor's protocol ID
CQGE031C2201E1
Other IDs
2015-003636-13, 2015
Status last verified
Oct 2021
First submitted
15 Dec 2015
Last updated
11 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 67 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 5 inclusion and 8 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Spain, Japan, Germany, Australia 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. 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 Aug 2020). 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?

Number of Participants With at Least One Treatment Emergent Adverse Event (AE) (time frame: Within 16 weeks after Week 48). 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 NCT02649218, which also lists 2 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 11 Oct 2021.

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