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Global Managed Access Program Cohort for Ligelizumab in CSU

Primary Purpose

Chronic Spontaneous Urticaria

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Ligelizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Spontaneous Urticaria focused on measuring chronic spontaneous urticaria, CSU, ligelizumab, QGE031, MAP, Managed Access Program, cohort, Anti-IgE, Urticaria, Skin Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult male and female subjects (≥ 18 years) who are able and willing to provide written informed consent prior to enrolling in the cohort.
  2. CSU diagnosis for ≥ 6 months (defined as onset of CSU with supporting documentation).
  3. Diagnosis of CSU refractory to H1-AH at locally label approved doses and to omalizumab, as assessed by the treating physician, using one of the following tools: UAS7, UCT or DLQI
  4. Not eligible or able to enroll in a clinical trial or no relevant clinical trials available

Exclusion Criteria:

  1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ligelizumab.
  2. Contraindications or hypersensitivity to H1-antihistamines (including but not limited to fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine), epinephrine or any of their ingredients or excipients.
  3. History of anaphylaxis.
  4. Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism.
  5. Presence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to enrollment in Cohort MAP), neurological, psychiatric, metabolic or other pathological conditions (such as but not limited to cerebrovascular disease, neurodegenerative or other neurological diseases, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state or ophthalmologic disorder) that could interfere with or compromise the safety of the subjects, as assessed by the treating physician.
  6. Use of prohibited treatment detailed in the treatment plan.
  7. History of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses or Bowen disease (carcinoma in situ) that have been treated, with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  8. History of, or current treatment for, hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure prior to initiation of ligelizumab first dose.
  9. History of renal disease or creatinine level above 1.5x ULN prior to initiation of ligelizumab first dose.
  10. Pregnant or nursing (lactating) women.
  11. Female patients of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic (acceptable effective) methods of contraception for the duration of the treatment.

Basic (acceptable effective) contraception methods include:

  1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable effective methods of contraception
  2. Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment
  3. Male sterilization (at least 6 months prior to initiation of ligelizumab first dose). For female patients enrolled in the Cohort MAP, the vasectomized male partner should be the sole partner for that patient.
  4. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/ vaginal suppository
  5. Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS)

In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.

Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 21, 2021
    Last Updated
    May 6, 2022
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04903613
    Brief Title
    Global Managed Access Program Cohort for Ligelizumab in CSU
    Official Title
    Global Managed Access Program (MAP) Cohort to Provide Access to Ligelizumab (QGE031) for Chronic Spontaneous Urticaria (CSU).
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Spontaneous Urticaria
    Keywords
    chronic spontaneous urticaria, CSU, ligelizumab, QGE031, MAP, Managed Access Program, cohort, Anti-IgE, Urticaria, Skin Disease

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ligelizumab
    Other Intervention Name(s)
    QGE031
    Intervention Description
    Ligelizumab 120 mg s.c every 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult male and female subjects (≥ 18 years) who are able and willing to provide written informed consent prior to enrolling in the cohort. CSU diagnosis for ≥ 6 months (defined as onset of CSU with supporting documentation). Diagnosis of CSU refractory to H1-AH at locally label approved doses and to omalizumab, as assessed by the treating physician, using one of the following tools: UAS7, UCT or DLQI Not eligible or able to enroll in a clinical trial or no relevant clinical trials available Exclusion Criteria: History of hypersensitivity to any drugs or metabolites of similar chemical classes as ligelizumab. Contraindications or hypersensitivity to H1-antihistamines (including but not limited to fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine), epinephrine or any of their ingredients or excipients. History of anaphylaxis. Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism. Presence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to enrollment in Cohort MAP), neurological, psychiatric, metabolic or other pathological conditions (such as but not limited to cerebrovascular disease, neurodegenerative or other neurological diseases, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state or ophthalmologic disorder) that could interfere with or compromise the safety of the subjects, as assessed by the treating physician. Use of prohibited treatment detailed in the treatment plan. History of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses or Bowen disease (carcinoma in situ) that have been treated, with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). History of, or current treatment for, hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure prior to initiation of ligelizumab first dose. History of renal disease or creatinine level above 1.5x ULN prior to initiation of ligelizumab first dose. Pregnant or nursing (lactating) women. Female patients of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic (acceptable effective) methods of contraception for the duration of the treatment. Basic (acceptable effective) contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable effective methods of contraception Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment Male sterilization (at least 6 months prior to initiation of ligelizumab first dose). For female patients enrolled in the Cohort MAP, the vasectomized male partner should be the sole partner for that patient. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/ vaginal suppository Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential.

    12. IPD Sharing Statement

    Learn more about this trial

    Global Managed Access Program Cohort for Ligelizumab in CSU

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