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Urticaria clinical trials

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NCT ID: NCT04444466 Terminated - Clinical trials for Chronic Spontaneous Urticaria

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants

Start date: June 30, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.

NCT ID: NCT04439955 Completed - Clinical trials for Chronic Spontaneous Urticaria

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Start date: February 1, 2020
Phase: Phase 2
Study type: Interventional

Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil). After the run-in period, doses of CBD will be incresed during the first six weeks of the study. At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three month. Each patient will serve as his/her own control.

NCT ID: NCT04426890 Completed - Clinical trials for Chronic Spontaneous Urticaria

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

omalizumab
Start date: December 9, 2020
Phase: Phase 3
Study type: Interventional

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine Treatment

NCT ID: NCT04404023 Not yet recruiting - Clinical trials for Chronic Spontaneous Urticaria

Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers

Start date: December 1, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

NCT ID: NCT04314999 Completed - Clinical trials for Chronic Spontaneous Urticaria

Frequency of Parasite Infestation in Patients With Chronic Spontaneous Urticaria

Start date: June 1, 2019
Phase:
Study type: Observational

The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia.

NCT ID: NCT04213274 Not yet recruiting - Schnitzler Syndrome Clinical Trials

Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome

Start date: May 2023
Phase: Phase 2
Study type: Interventional

The primary goal of the study is to assess the efficacy and safety of RPH-104 in subjects with Schnitzler Syndrome using Schnitzler Disease Activity Score (SDAS), which includes the Physician's Global Assessment (PGA) and the local laboratory C-reactive protein (CRP) result

NCT ID: NCT04210843 Terminated - Clinical trials for Chronic Spontaneous Urticaria

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

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

NCT ID: NCT04210323 Completed - Clinical trials for Chronic Spontaneous Urticaria

Shotblocker® Use in Subcutaneous Injection

Start date: June 5, 2018
Phase: N/A
Study type: Interventional

Aim: The aim of this study was to investigate the effect of subcutaneous injection with ShotBlocker® on patients with chronic spontaneous urticaria. Background: In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level. Design: Randomized placebo controlled. Methods: Data were collected between June-November 2018 by including 90 patients out of 125 patients with Chronic Spontaneous Urticaria in Dermatology Clinic, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Patients were divided into three groups as intervention, control and shotblocker group. Patients in the placebo group were administered with the reverse side of ShotBlocker® during subcutaneous injection, and no intervention was performed in the control group. The group using ShotBlocker® for subcutaneous injection was compared with the placebo and control groups.

NCT ID: NCT04180488 Active, not recruiting - Clinical trials for Chronic Spontaneous Urticaria

Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

Start date: December 11, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control To demonstrate improvement in health-related quality of life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) To evaluate safety outcome measures To evaluate immunogenicity of dupilumab

NCT ID: NCT04175704 Not yet recruiting - Clinical trials for Chronic Idiopathic Urticaria

Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

Start date: December 30, 2023
Phase: Phase 1
Study type: Interventional

The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.