Chronic Spontaneous UrticariaPhase 1MASTERNCT04513548
Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
A Phase 1 study testing Ligelizumab in people with Chronic Spontaneous Urticaria and Cholinergic Urticaria, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria. The study has two parts. The study population will consist of approximately 68 male and female healthy volunteers and patients. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Spontaneous Urticaria, Cholinergic Urticaria, Cold Urticaria
- What is being tested?
- Ligelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2020to 19 Jul 2022
- Phase
- Phase 1
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers • Healthy male and female subjects in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- CSU and CINDU patients (cold and cholinergic urticaria)
- Part 2: Positive response to challenge test with ciprofloxacin 250 mg/ml or 125 mg/ml, defined as a wheal formation with longest diameter of at least 3 mm and middle perpendicular diameter of at least 2 mm at Day 1.
- CSU patients
- Diagnosis of CSU, not adequately controlled with H1-AH at approved doses alone at the time of randomization, as defined by all of the following:
- UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization
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- CSU for ≥ 6 months CINDU patients (cold and cholinergic urticaria)
- For patients with cold urticaria: Cold urticaria symptoms persisting for at least 6 months prior to study enrollment and a positive cold urticaria provocation test defined as wheal response to TempTest 4.0® at Day 1.
- For patients with cholinergic urticaria: Cholinergic urticaria symptoms for at least 6 months prior to enrollment and a positive response in the challenge test defined as a wheal response in the pulse controlled ergometry provocation test (30 minutes bicycle challenge) at Day 1
Who cannot join
- Healthy volunteers
- History of allergies or allergy to the challenge substances including ciprofloxacin, icatibant, other quinolones or excipients of the substances being used in the study.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.).
- Donation or loss of 450 mL or more blood within eight weeks prior to initial dosing, or longer if required by local regulations.
- CSU and CINDU patients (cold and cholinergic urticaria)
- History of allergies or allergy to the challenge substances including ciprofloxacin, icatibant (Part 1 only), other quinolones or excipients of the substances being used in this study.
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- Contraindications to or hypersensitivity to antihistamines (such as fexofenadine, loratadine, cetirizine, rupatadine, bilastine) or epinephrine or any of the ingredients.
- History or presence of renal disease and/or estimated glomerular filtration (eGFR) rate of < 35 mL/min as calculated by the CKD-EPI formula at Screening.
- For subjects who enter Part 2: Patients with a history of or a risk of parasite infections (recent stay in tropical/subtropical areas with low hygiene standards). To allow enrollment of a patient at risk perform stool examinations for ova or parasites and demonstrate absence of infection first.
- Diseases with possible signs and symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g. due to C1 inhibitor deficiency).
- CSU patients • Clearly defined underlying etiology for chronic urticaria symptoms other than CSU. This includes the following: CSU patients should not have inducible urticaria forms impacting their daily symptoms in a relevant way, such as but not limited to urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure, aquagenic-, cholinergic-, or contact-urticaria.
- CINDU patients (cold and cholinergic urticaria)
- Clearly defined underlying etiology for chronic urticaria symptoms other than CINDU. This includes the following: CINDU patients should not have spontaneous urticaria impacting their symptoms in a relevant way.
- Other protocol-defined inclusion/exclusion criteria may apply .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part Exploratory Study Combining a Pilot Study in Healthy Subjects and Chronic Spontaneous Urticaria Patients (Part 1) and a Randomized, Subject, Investigator and Sponsor-blinded, Placebo Controlled, Study (Part 2) to Assess the MechAniSm of acTion of ligElizumab (QGE031) in Patients With Chronic uRticaria (MASTER)
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria.
The study has two parts. The study population will consist of approximately 68 male and female healthy volunteers and patients. In Part 1, approximately 20 healthy volunteers and patients with chornic urticaria will be enrolled. In Part 2 approximately 48 patients with chronic urticaria (spontaneous chronic urticaria, cholinergic urticaria or cold urticaria). Part 1 consists of a screening period up 2 weeks and a visit with skin tests; there is no treatment taken in Part 1. Part 2 is randomized, subject, investigator and sponsor blinded. It consists of a screening period up to 4 weeks, a 16 week treatment period and a 12-week follow-up period after last treatment. A follow-up call at Week 32 will be performed via telephone.
Read the detailed description
There are 58 patients out of 68 participants (10 are Healthy Volunteers)
- Being tested
- Ligelizumab, Placebo
- Keywords
- chronic spontaneous urticaria, chronic inducible urticaria, cholinergic urticaria, cold urticaria, ligelizumab (QGE031)
- Medical subject headings
- Chronic Urticaria, Cold Urticaria, Chronic Inducible Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigelizumabDrug
One injection every four weeks
PlaceboDrug
One injection every four weeks
| Study group | Role | What they receive |
|---|---|---|
| Ligelizumab | Experimental | test drug Receives: Drug: Ligelizumab |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Wheal and erythema size after skin prick test with several different ciprofloxacin and icatibant concentrations.
Size of the wheal and erythema in mm will be measured after the skin prick and intradermal tests are performed. Different dilution steps will be applied (to differentiate Chronic Spontaneous Urticaria patients and healthy controls) for ciprofloxacin and icatibant to determine the conditions to be used in Part 2.
Measured: At Day 1
Part 2: Change in wheal size after challenge procedure from Day 1 (pre-dose) to week 16.
Size of wheal in mm2 after skin prick test and autologous serum skin test will be measured.
Measured: Day 1 and Week 16
Secondary outcomes (9)
Part 2: Urticaria Control Test
The Urticaria Control Test (UCT) is a questionnaire that assesses the extent of the disease control over the previous 4 weeks. It consists of 4 questions, each rated from 0 to 4 points. Subsequently, the scores for all 4 questions are summed up. The minimum and maximum UCT scores are 0 and 16, with 12 points or higher indicating controlled disease, and 16 points indicating complete disease control.
Measured: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Part 2: Weekly Urticaria Activity Score
Chronic Spontaneous Urticaria (CSU) patients: The Urticaria Activity Score (UAS) is evaluated in the screening period and throughout the study. It records each morning and evening on a daily basis symptoms of itch and hives into a patient diary. The UAS is a composite score with numeric severity intensity ratings on a scale of 0 - 3 for the number of wheals (hives) and the itch intensity. The UAS7 is the sum of the daily UAS scores over 7 days. UAS7 values range from 0 to 42, with higher values indicate higher disease activity.
Measured: Throughout the study (to 28 weeks)
Part 2: Cholinergic Urticaria Activity score
Cholinergic urticaria patients: Cholinergic Urticaria Activity score (CholUAS) is a questionnaire that records each evening on a daily basis symptoms of itch and hives and the general assessment of disease severity into a patient diary. The CholUAS is a composite score with numeric ratings on a scale of 0 - 3 for the intensity of wheals (hives), the itch intensity, and the overall assessment of the disease severity. The total score is a sum of scores multiplied with the score for the trigger. The CholUAS7 is the sum of the daily CholUAS scores over 7 days. Higher values indicate a higher disease activity.
Measured: Day 1 to Week 28
Part 2: Chronic Urticaria Quality of Life questionnaire
CSU patients: The Chronic Urticaria Quality of Life questionnaire (CU-Q2oL) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). with a total score of 0 to 100 %. Higher scores indicate higher impairment in quality of life.
Measured: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Part 2: Angioedema control test
CSU patients with angioedema: Angioedema Control Test (AECT) is a questionnaire that assesses the extent of the symptom control (angioedema). It consists of 4 questions, each rated from 0 to 4 points. Subsequently, the scores for all 4 questions are summed up. The minimum and maximum AECT scores are 0 and 16, with 10 points or higher indicating controlled disease, and 16 points indicating complete disease control.
Measured: Day 1, Week 16, Week 28
Part 2: Cholinergic Urticaria Quality of Life questionnaire
Cholinergic patients: The Cholinergic Urticaria Quality of Life questionnaire (Chol-Q2oL) is a questionnaire that measures the relative burden of cholinergic urticaria on subjective well-being. The questionnaire consists of 28 items, each item being scored between 0 and 4. Higher scores indicate higher impairment in quality of life.
Measured: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Part 2: Provocation test for cholinergic patients
Cholinergic patients: Time from onset of sweating and urticaria symptoms after an exercise on a stationary bicycle.
Measured: Day 1, Week 4, Week 16, Week 28
Part 2: Temperature trigger test for cold urticaria patients
Cold urticaria patients: The temperature that will provoke the formation of wheals will be assessed.
Measured: Day 1, Week 4, Week 16, Week 28
Part 2: Number of patients with adverse events
Part 2: Safety and tolerability
Measured: Throughout the study (to 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start5 Aug 2020
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Why it stopped: Company decision
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513548
- Sponsor's protocol ID
- CQGE031C2203
- Other IDs
- 2019-001048-24, 2019
- Acronym
- MASTER
- Status last verified
- Jun 2024
- First submitted
- 7 Aug 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Exploratory Study Combining a Pilot Study in Healthy Subjects and Chronic Spontaneous Urticaria Patients (Part 1) and a Randomized, Subject, Investigator and Sponsor-blinded, Placebo Controlled, Study (Part 2) to Assess the MechAniSm of acTion of ligElizumab (QGE031) in Patients With Chronic uRticaria (MASTER)
- ClinicalTrials.gov ID
- NCT04513548
- Acronym / sponsor ID
- MASTER / CQGE031C2203
- Keywords
- chronic spontaneous urticaria, chronic inducible urticaria, cholinergic urticaria, cold urticaria, ligelizumab (QGE031)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 14 Aug 2020 (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.
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria.
The study has two parts. The study population will consist of approximately 68 male and female healthy volunteers and patients. In Part 1, approximately 20 healthy volunteers and patients with chornic urticaria will be enrolled. In Part 2 approximately 48 patients with chronic urticaria (spontaneous chronic urticaria, cholinergic urticaria or cold urticaria). Part 1 consists of a screening period up 2 weeks and a visit with skin tests; there is no treatment taken in Part 1. Part 2 is randomized, subject, investigator and sponsor blinded. It consists of a screening period up to 4 weeks, a 16 week treatment period and a 12-week follow-up period after last treatment. A follow-up call at Week 32 will be performed via telephone.
Detailed description
There are 58 patients out of 68 participants (10 are Healthy Volunteers)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligelizumab | Experimental | Drug: Ligelizumabtest drug |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy volunteers • Healthy male and female subjects in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- CSU and CINDU patients (cold and cholinergic urticaria)
- Part 2: Positive response to challenge test with ciprofloxacin 250 mg/ml or 125 mg/ml, defined as a wheal formation with longest diameter of at least 3 mm and middle perpendicular diameter of at least 2 mm at Day 1.
- CSU patients
- Diagnosis of CSU, not adequately controlled with H1-AH at approved doses alone at the time of randomization, as defined by all of the following:
Key exclusion criteria (14 listed)
- Healthy volunteers
- History of allergies or allergy to the challenge substances including ciprofloxacin, icatibant, other quinolones or excipients of the substances being used in the study.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.).
- Donation or loss of 450 mL or more blood within eight weeks prior to initial dosing, or longer if required by local regulations.
- CSU and CINDU patients (cold and cholinergic urticaria)
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 |
|---|---|---|
| LigelizumabOne injection every four weeks | Drug | Ligelizumab |
| PlaceboOne injection every four weeks | Drug | Placebo |
Primary outcome
Part 1: Wheal and erythema size after skin prick test with several different ciprofloxacin and icatibant concentrations.
Time frame: At Day 1
Size of the wheal and erythema in mm will be measured after the skin prick and intradermal tests are performed. Different dilution steps will be applied (to differentiate Chronic Spontaneous Urticaria patients and healthy controls) for ciprofloxacin and icatibant to determine the conditions to be used in Part 2.
Part 2: Change in wheal size after challenge procedure from Day 1 (pre-dose) to week 16.
Time frame: Day 1 and Week 16
Size of wheal in mm2 after skin prick test and autologous serum skin test will be measured.
9 secondary outcomes
Part 2: Urticaria Control Test
Time frame: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Part 2: Weekly Urticaria Activity Score
Time frame: Throughout the study (to 28 weeks)
Part 2: Cholinergic Urticaria Activity score
Time frame: Day 1 to Week 28
Part 2: Chronic Urticaria Quality of Life questionnaire
Time frame: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Part 2: Angioedema control test
Time frame: Day 1, Week 16, Week 28
Part 2: Cholinergic Urticaria Quality of Life questionnaire
Time frame: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Part 2: Provocation test for cholinergic patients
Time frame: Day 1, Week 4, Week 16, Week 28
Part 2: Temperature trigger test for cold urticaria patients
Time frame: Day 1, Week 4, Week 16, Week 28
Part 2: Number of patients with adverse events
Time frame: Throughout the study (to 28 weeks)
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Results for CQGE031C2203 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Patient Lay Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ligelizumab in people with Chronic Spontaneous Urticaria and Cholinergic Urticaria, run by Novartis Pharmaceuticals at 1 site in Germany.
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 9 inclusion and 14 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: stopped early, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision). 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.
What does the primary outcome measure?
Part 1: Wheal and erythema size after skin prick test with several different ciprofloxacin and icatibant concentrations. (time frame: At Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Jun 2024.