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A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

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ClinicalTrials.gov Identifier: NCT03580369
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab.

The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.


Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Biological: Ligelizumab Biological: Omalizumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients, investigator staff and personnel performing the study assessments will remain blinded to the identity of the treatment from the time of randomization until final database lock. The study drug must be prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator will be involved in any assessments.
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : May 4, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ligelizumab Dose A
Ligelizumab Dose A q4w
Biological: Ligelizumab
Liquid in vial

Experimental: Ligelizumab Dose B
Ligelizumab Dose B q4w
Biological: Ligelizumab
Liquid in vial

Active Comparator: Omalizumab 300 mg
Omalizumab 300 mg q4w
Biological: Omalizumab
Lyophilized powder for solution in vial

Placebo Comparator: Placebo
Placebo q4w from randomization to week 20. Ligelizumab Dose B from week 24 to week 48.
Other: Placebo
Liquid in vial




Primary Outcome Measures :
  1. Absolute change from baseline in UAS7 at Week 12 [ Time Frame: Week 12 ]

    The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).

    The HSS has a scale of 0 (none) to 3 (intense/severe). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days.

    The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days.

    The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42.

    Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0.

    Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0.

    Complete UAS7 response is defined as UAS7 = 0.



Secondary Outcome Measures :
  1. Complete absence of hives and itch at Week 12 [ Time Frame: Week 12 ]
    Assessed as percentage of subjects achieving UAS7 = 0

  2. Improvement of severity of itch [ Time Frame: Week 12 ]
    Assessed as absolute change from baseline in ISS7 score at Week 12

  3. No impact on subjects quality of life at Week 12 [ Time Frame: Week 12 ]
    Assessed as percentage of subjects achieving DLQI = 0-1

  4. Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 [ Time Frame: Weekly to Week 12 ]
    To assess the cumulative period of time that treated subjects are angioedema occurrence-free

  5. Occurrence of treatment emergent adverse events and serious adverse events during the study [ Time Frame: 52 weeks ]
    Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
  • Male and female subjects ≥ 12 years of age at the time of screening.
  • CSU diagnosis for ≥ 6 months.
  • Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
  • The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
  • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
  • Subjects must be on H1-antihistamine at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
  • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Key Exclusion Criteria:

  • History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
  • Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
  • Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
  • Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
  • Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
  • Prior exposure to ligelizumab or omalizumab.
  • Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580369


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

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Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03580369     History of Changes
Other Study ID Numbers: CQGE031C2302
2018-000839-28 ( EudraCT Number )
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Anti-IgE, CSU (chronic spontaneous urticarial), hives severity score, itch severity score, urticaria activity score

Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Histamine Antagonists
Histamine H1 Antagonists
Antibodies, Anti-Idiotypic
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Immunologic Factors