Chronic Spontaneous UrticariaNCT04903613
Global Managed Access Program Cohort for Ligelizumab in CSU
A study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals.
Trial summary
Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Ligelizumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
About this study
Official title: Global Managed Access Program (MAP) Cohort to Provide Access to Ligelizumab (QGE031) for Chronic Spontaneous Urticaria (CSU).
Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Ligelizumab
- Keywords
- chronic spontaneous urticaria, CSU, ligelizumab, QGE031, MAP, Managed Access Program, cohort, Anti-IgE, Urticaria, Skin Disease
- Medical subject headings
- Chronic Urticaria, Urticaria, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigelizumabDrug
Also called QGE031
Ligelizumab 120 mg s.c every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903613
- Sponsor's protocol ID
- CQGE031C2006M
- Status last verified
- May 2022
- First submitted
- 21 May 2021
- Last updated
- 11 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Managed Access Program (MAP) Cohort to Provide Access to Ligelizumab (QGE031) for Chronic Spontaneous Urticaria (CSU).
- ClinicalTrials.gov ID
- NCT04903613
- Acronym / sponsor ID
- CQGE031C2006M
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- chronic spontaneous urticaria, CSU, ligelizumab, QGE031, MAP, Managed Access Program, cohort, Anti-IgE
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| LigelizumabAlso: QGE031Ligelizumab 120 mg s.c every 4 weeks | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals.
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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 May 2022; AzTrials last refreshed its copy on 26 Oct 2026.