Clinical Trials

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Rochester, MN

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Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to establish effectiveness and safety of ligelizumab. This will be assessed in patients with chronic spontaneous urticaria (CSU) who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. For this curreent study only adults will be enrolled, as no adolescents were enrolled in the previous study (CQGE031C2303). In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed. This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 20-007036
NCT ID:
NCT04210843
Sponsor Protocol Number:
CQGE031C2302E1

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of Chronic Spontaneous Urticaria in Adults Inadequately Controlled by H1-antihistamines

Rochester, MN

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A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of Chronic Spontaneous Urticaria in Adults Inadequately Controlled by H1-antihistamines

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to establish the effectiveness, safety, and tolerability of remibrutinib (LOU064) 25 mg b.i.d. in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 21-008540
NCT ID:
NCT05032157

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

Rochester, MN

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A Long Term Safety Study of BCX7353 in Hereditary Angioedema

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2/3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the long-term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angiodema (HAE).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 19-010175
NCT ID:
NCT03472040
Sponsor Protocol Number:
BCX7353-204

A Study to Evaluate the Effectiveness and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema in Adolescents and Adults

Rochester, MN

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A Study to Evaluate the Effectiveness and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema in Adolescents and Adults

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the safety and effectiveness of repeated subcutaneous (SC) administrations of Lanadelumab in preventing angioedema attacks in adolescents and adults with non-histaminergic angioedema with normal C1-INH and in adults with acquired angioedema (AAE) due to C1-INH deficiency.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 20-003965
NCT ID:
NCT04206605
Sponsor Protocol Number:
SHP643-303

A Study to Evaluate the Safety and Effectiveness of Lanadelumab to Prevent Acute Attacks of Non-histaminergic Angioedema

Rochester, MN

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A Study to Evaluate the Safety and Effectiveness of Lanadelumab to Prevent Acute Attacks of Non-histaminergic Angioedema

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the long-term safety and effectiveness of repeated subcutaneous (SC) administration of lanadelumab in adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 21-001433
NCT ID:
NCT04444895

A Study of to Determine the Effectiveness and Safety of Ligelizumab in the Treatment of Chronic Spontaneous Urticaria (CSU)(Hives) in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Rochester, MN

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A Study of to Determine the Effectiveness and Safety of Ligelizumab in the Treatment of Chronic Spontaneous Urticaria (CSU)(Hives) in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to establish effectivess and safety of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU), or Hives, 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 18-008842
NCT ID:
NCT03580356
Sponsor Protocol Number:
CQGE031C2303

A Study to Collect Long-Term Data on Pediatric Cutaneous Mastocytosis

Rochester, MN

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A Study to Collect Long-Term Data on Pediatric Cutaneous Mastocytosis

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to develop a registry to collect long-term data on patients with pediatric cutaneous mastocytosis, and develop better knowledge of the timing, symptoms, resolution or progression of the disease, and predictive markers of its severity.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 15-007883
Sponsor Protocol Number:
15-007883

Clinical Criteria for the Diagnosis of Anaphylaxis in Emergency Department Patients

Rochester, MN

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Clinical Criteria for the Diagnosis of Anaphylaxis in Emergency Department Patients

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The goal is to assess the criterion and predictive validity of the diagnostic criteria for anaphylaxis proposed by the 2nd Symposium on the Definition and Management of Anaphylaxis. Determination of the clinical utility of the diagnostic criteria is essential for the criteria to be widely adopted into clinical practice. Prospectively, the NIAID/FAAN criteria continued to be highly sensitive (95%) but had lower specificity (71%) than on retrospective assessment. These criteria are likely to be useful for the diagnosis of anaphylaxis in the ED.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Closed-enrolling by invitation

View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 10-001847
Sponsor Protocol Number:
10-001847

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Search Results 1-8 of 8 for

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of Chronic Spontaneous Urticaria in Adults Inadequately Controlled by H1-antihistamines

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

A Study to Evaluate the Effectiveness and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema in Adolescents and Adults

A Study to Evaluate the Safety and Effectiveness of Lanadelumab to Prevent Acute Attacks of Non-histaminergic Angioedema

A Study of to Determine the Effectiveness and Safety of Ligelizumab in the Treatment of Chronic Spontaneous Urticaria (CSU)(Hives) in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

A Study to Collect Long-Term Data on Pediatric Cutaneous Mastocytosis

Clinical Criteria for the Diagnosis of Anaphylaxis in Emergency Department Patients

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