Spontaneous Urticaria
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CLINICAL_TRIALS trial_result · 2023-07-13Clinical Trial Update: Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab [Phase 3]
Phase 3 trial of ligelizumab in chronic spontaneous urticaria was terminated. Results have been posted for patients who completed a prior li…
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CLINICAL_TRIALS trial_result · 2022-12-30Clinical Trial Update: A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines [Phase 3]
A Phase III clinical trial assessing safety and efficacy of ligelizumab for chronic spontaneous urticaria in adolescents and adults inadequa…
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CLINICAL_TRIALS trial_result · 2022-10-07Clinical Trial Update: A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria [Phase 2]
Phase 2 clinical trial evaluating UB-221 IV as add-on therapy for chronic spontaneous urticaria, focusing on pharmacodynamics, pharmacokinet…
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CLINICAL_TRIALS trial_result · 2022-03-11Clinical Trial Update: A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria [Phase 2]
Phase 2 study of LY3454738 in adults with chronic spontaneous urticaria was terminated, with results posted.
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CLINICAL_TRIALS trial_result · 2022-02-16Clinical Trial Update: This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines [Phase 2]
Phase 2 dose-finding study evaluating LOU064 for efficacy and safety in chronic spontaneous urticaria inadequately controlled by H1-antihist…
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CLINICAL_TRIALS trial_result · 2022-02-02Clinical Trial Update: Dupilumab in Chronic Spontaneous Urticaria [Phase 2]
Phase 2 clinical trial update for dupilumab in chronic spontaneous urticaria and recurrent angioedema completed.
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CLINICAL_TRIALS trial_result · 2021-08-24Clinical Trial Update: Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU) [Phase 2]
A Phase 2 trial evaluated the efficacy and safety of QGE031 (ligelizumab) in adolescent patients with chronic spontaneous urticaria; the stu…
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CLINICAL_TRIALS trial_result · 2021-06-29Clinical Trial Update: Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria [Phase 3]
Phase 3 trial evaluating therapeutic equivalence of SYN008 vs Xolair in refractory chronic spontaneous urticaria.
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CLINICAL_TRIALS trial_result · 2021-05-20Clinical Trial Update: Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria [Phase 2, Phase 3]
A phase 2/3 clinical trial update on low-dose interleukin-2 treatment for chronic spontaneous urticaria is reported, with current status und…
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CLINICAL_TRIALS trial_result · 2021-04-28Clinical Trial Update: Tranexamic Acid and Spontaneous Chronic Urticaria [Phase 4]
Phase 4 trial update involving tranexamic acid for chronic spontaneous urticaria.
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FDA label_change · 2021-04-09FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for XOLAIR (omalizumab) filed by Genentech to modify the labeling.
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CLINICAL_TRIALS trial_result · 2020-11-04Clinical Trial Update: Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria [Phase 3]
Phase 3 trial evaluating efficacy and safety of Xolair (omalizumab) in Chinese patients with chronic spontaneous urticaria has completed wit…
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CLINICAL_TRIALS trial_result · 2020-09-29Clinical Trial Update: A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). [Phase 2]
Phase 2 trial update for GDC-0853 in refractory chronic spontaneous urticaria (CSU) has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-09-09Clinical Trial Update: Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy [Phase 3]
Phase 3 trial assessing omalizumab's impact on quality of life and angioedema frequency in patients with chronic spontaneous urticaria refra…
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CLINICAL_TRIALS trial_result · 2020-08-14Clinical Trial Update: A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients [Phase 2]
Phase 2 safety extension study assessing long-term safety of QGE031 (ligelizumab) in chronic spontaneous urticaria; completed with results p…
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FDA approval · 2020-04-29FDA Approved: CURIST ALLERGY RELIEF — Original Application (Little Pharma, Inc.)
FDA approved Little Pharma, Inc.'s CURIST ALLERGY RELIEF as the original ANDA for levocetirizine dihydrochloride 5 mg, a generic tablet for …
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CLINICAL_TRIALS trial_result · 2020-02-25Clinical Trial Update: Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment [Phase 4]
Phase 4 study updating on omalizumab in chronic spontaneous urticaria patients not responding to initial antihistamine treatment; results po…
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CLINICAL_TRIALS trial_result · 2018-09-18Clinical Trial Update: Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria [Phase 3]
Phase 3 trial evaluating fourfold dosage of levocetirizine for chronic spontaneous urticaria has completed.
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CLINICAL_TRIALS trial_result · 2018-09-14Clinical Trial Update: Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU [Phase 2]
Phase 2 dose-finding trial of QGE031 as add-on therapy for chronic spontaneous urticaria has completed with results posted.
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CLINICAL_TRIALS trial_result · 2018-08-08Clinical Trial Update: OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients [Phase 3]
Phase 3 trial updates on re-treatment and step-up therapy with omalizumab for chronic spontaneous urticaria (CSU) completed with posted resu…
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FDA label_change · 2018-06-27FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for levocetirizine dihydrochloride (Glenmark Pharmaceuticals Inc., USA) under the ANDA process, lead…
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CLINICAL_TRIALS trial_result · 2018-03-26Clinical Trial Update: A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria [Phase 4]
This Phase 4 trial update reports the efficacy and safety of omalizumab through 48 weeks in participants with chronic spontaneous urticaria.
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CLINICAL_TRIALS trial_result · 2016-11-02Clinical Trial Update: A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria [Phase 2]
This document reports the completion of a Phase 2 randomized trial comparing quilizumab to placebo in patients with refractory chronic spont…
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CLINICAL_TRIALS trial_result · 2016-09-20Clinical Trial Update: Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients [Phase 3]
A Phase 3 trial evaluating the efficacy and safety of omalizumab in patients with refractory chronic spontaneous urticaria has completed, wi…
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CLINICAL_TRIALS trial_result · 2016-08-26Clinical Trial Update: Bilastine Updosing in Chronic Spontaneous Urticaria [Phase 3]
Phase 3 trial update on bilastine dosing for chronic spontaneous urticaria; the study has completed.