Estudio primario

No clasificado

A multicenter, randomized, double-blind, placebo- controlled phase 2b dose-finding study to investigate the efficacy, safety and tolerability of LOU064 in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines

Año 2019
Autores Novartis Pharma AG
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Product Code: LOU064 Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

Not yet established Current Sponsor code: LOU064 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: LOU064 Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

Not yet established Current Sponsor code: LOU064 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: LOU064 Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

Not yet established Current Sponsor code: LOU064 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

CONDITION:

Chronic Spontaneous Urticaria ; MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 ‐ Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17]

PRIMARY OUTCOME:

; Secondary Objective: To evaluate:; ‐ the efficacy of LOU064 compared to placebo with respect to change from baseline in UAS7 at Week 12; ‐ the efficacy of LOU064 compared to placebo with respect to change from baseline in UAS7 over time; ‐ the efficacy of LOU064 compared to placebo with respect to achievement of complete clinical response (UAS7= 0) over time; ‐ the efficacy of LOU064 compared to placebo with respect to achievement of disease control (UAS7= 6) over time; ‐ the effect of LOU064 on angioedema (AAS7) with respect to the number of weeks with an AAS7= 0 response from baseline through Week 12; ‐ the effect of LOU064 on disease‐related quality of life with respect to achievement of a DLQI score of 0 or 1 at Week 4 and Week 12; ‐ the effect of LOU064 on CSU related quality of life with respect to change from baseline in DLQI at Week 4 and Week 12; ‐ the pharmacokinetics of LOU064 resulting from oral dosing at Week 4 and Week 12; ‐ safety and tolerability of LOU064 in subjects with CSU; Main Objective: To characterize the dose‐response relationship of LOU064 administered once or twice daily in subjects with CSU with respect to change from baseline in UAS7 at Week 4 Primary end point(s): Change from baseline in weekly Urticaria Activity Score (UAS7) Timepoint(s) of evaluation of this end point: week 4

SECONDARY OUTCOME:

; Secondary end point(s): ‐ Change from baseline in UAS7 at Week 12 ; ‐ Change from baseline in UAS7 over time ; ‐ Complete absence of hives and itch, assessed as UAS7= 0 response over time ; ‐ Disease control (UAS7= 6) over time ; ‐ Cumulative number of weeks with an AAS7= 0 response between baseline and Week 12 ; ‐ DLQI score of 0 or 1 at Week 4 and 12 ; ‐ Change from baseline in DLQI score at Week 4 and 12 ; ‐ Concentrations of LOU064 in blood and calculation of respective PK parameters at ; Week 4 and Week 12 ; ‐ Safety endpoints will include but not be limited to: ; ‐ Occurrence of treatment emergent adverse events during the study ; ‐ Occurrence of treatment emergent serious adverse events during the study; Timepoint(s) of evaluation of this end point: week 4 and week 12

INCLUSION CRITERIA:

1. Signed informed consent must be obtained prior to participation in the study 2. Male and female subjects aged =18 years of age 3. CSU diagnosis for = 6 months prior to screening 4. Diagnosis of CSU inadequately controlled by second generation H1‐antihistamines at the time of randomization as defined in the following: ‐ The presence of itch and hives for =6 consecutive weeks prior to screening in spite of use of non‐sedating H1‐antihistamines according to local treatment guidelines during this time period ‐ UAS7 score (range 0‐42) =16 and HSS7 score (range 0‐21) = 8 during 7 days prior to randomization (Day 1) 5. Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study Other protocol‐defined inclusion criteria may apply A

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Estudio primario

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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy

Año 2016
Registro de estudios EU Clinical Trials Register
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Estudio primario

No clasificado

This is a clinical trial (study), to be conducted at multiple clinical sites, of an oral study drug (EP262) that will be investigated in adult participants with Chronic Inducible Urticaria (CIndU) to assess if it is safe and improves reactions to known CIndU triggers.

Año 2023
Registro de estudios Clinical Trials Information System
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Estudio primario

No clasificado

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LIGELIZUMAB (QGE031) IN THE TREATMENT OF CHRONIC SPONTANEOUS URTICARIA (CSU) IN ADOLESCENTS AND ADULTS INADEQUATELY CONTROLLED WITH H1-ANTIHISTAMINES

Año 2018
Registro de estudios Clinical Trials Peruvian Registry
Enlaces CTPR
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Estudio primario

No clasificado

A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)

Año 2004
Autores Organon and Co
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.

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Estudio primario

No clasificado

A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735)

Año 2004
Autores Organon and Co
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.

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Estudio primario

No clasificado

A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients with Chronic Inducible Urticaria(CIndU) Who Remain Symptomatic Despite Treatment with H1-Antihistamines

Año 2023
Registro de estudios Clinical Trials Information System
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Estudio primario

No clasificado

An exploratory phase III, randomised, double blind, therapeutic single dose-related effect, parallel group study to assess and compare the effects of 5mg vs. 20mg Desloratadine on skin lesions in patients with chronic urticaria (CU).

Año 2007
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Aerius Product Name: Desloratadine Product Code: SCH34117 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

DESLORATADINE CAS Number: 100643‐71‐8 Other descriptive name: Aerius Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use

CONDITION:

Chronic urticaria is characterized by the spontaneous development of wheal and flare type skin reactions. ; MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria ; MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria

PRIMARY OUTCOME:

Main Objective: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. Primary end point(s): The main goal of the analysis is to test whether treatment with 20 mg Desloratadine (DL) is more effective in reducing the size, distribution and kinetics of urticaria lesions (wheal and flare) than 5 mg DL.; The primary efficacy parameter of the study is the assessment of the reduction in size of urticaria lesions (wheal and flare) by thermography (within a defined area and period of time). Secondary Objective: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by digital time lapse photography.; Reduction in size of existing spontaneous urticaria lesions as assessed by volumetric analyses.; Reduction in size of new occuring spontaneous urticaria lesions (wheal and flare) as assessed by thermography.; Reduction in size of new occuring spontaneous urticaria lesions (wheal and flare) as assessed by digital time lapse photography.; Reduction in size of new occuring spontaneous urticaria lesions as assessed by volumetric analyses.; Reduction of urticaria symptoms.;

INCLUSION CRITERIA:

1. Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch. 2. Patients must exhibit spontaneous urticaria lesions at the randomization visit. 3. History of beneficial effects of antihistaminic treatment. 4. Age between 18 and 75 years. 5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 6. Voluntarily signed written informed consent.

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Estudio primario

No clasificado

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria

Año 2008
Autores UCB Pharma
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.

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Estudio primario

No clasificado

Angioedema and angioedema management from Asteria I and Asteria II: phase III studies to evaluate the efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Año 2014
Autores Zazzali J , Rosen K , BradleyMS , Raimundo K.
Revista J Allergy Clin Immunol
Enlaces

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