A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and...
Chronic Spontaneous UrticariaThe purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately...
Chronic Spontaneous UrticariaThe purpose of this study is to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses. The study population will consist of approximately 65 male and female subjects aged ≥ 18 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-AH. This is a Phase III multi-center, open-label, single arm study. There is a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.
Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency...
UrticariaAllergyA randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to the conventional treatment of H1 antihistamines
Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria...
UrticariaAutoimmune Diseases2 moreThe aim of this study is to determine whether autologous adipose tissue derived Mesenchymal Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Chronic Spontaneous UrticariaThis is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria...
Cholinergic UrticariaPhase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
Bilastine Updosing - Characterization of Underlying Mechanisms
Cold Contact UrticariaThis is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy, mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold contact urticaria (CCU). Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49, and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.
Stress Intervention for Chronic Urticaria
Chronic UrticariaStress and chronic urticaria has been linked. The purpose of the study is to evaluate a patients chronic urticaria and stress levels before and after he/she goes through six sessions designed to help that participant manage his/her stress.
Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses
UrticariaVasculitisThis is a single-center open label study to assess the efficacy and safety of single doses of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with active urticarial vasculitis. Efficacy is primarily assessed by a combined symptom score, the urticarial vasculitis activity score (UVAS). Following a baseline period of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg (consistent with a total dose of 300 mg canakinumab). Visits for investigator's assessments will be scheduled at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose. Patient's self-assessment will be performed on a daily basis throughout the study. Overall a max. of 10 subjects with urticarial vasculitis will be enrolled.
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers...
Chronic Idiopathic UrticariaAtopyThis study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.