Reseach study that will evaluate the efficacy and safety of Bilastine in reducing itching in patients with chronic spontaneous urticaria and other skin diseases.

Phase 1

• Conditions: Chronic spontaneous urticaria and the following skin disorders:1 - Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitisation dermatitis, dyshidrotic eczema, asteatotic eczema, lichen simplex chronicus).2 - Prurigo (acute prurigo, subacute prurigo, chronic prurigo).3 - Cutaneous pruritus (systemic cutaneous pruritus, local cutaneous pruritus).; MedDRA version: 19.0Level: HLTClassification code 10012435Term: Dermatitis and eczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 19.0Level: PTClassification code 10037083Term: PrurigoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 19.0Level: PTClassification code 10052568Term: Urticaria chronicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-001505-17-HU
• Lead Sponsor: FAES FARMA, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-16
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

General inclusion criteria:
Screening:
- Patients between 18 and 74 years of age at the time informed consent is obtained who can visit the participating medical institution as outpatients (either male or female).
- Patients who are able to provide written informed consent by themselves.
Enrollment:
- Patients who have not responded to the use of placebo during the run-in period (non-responder is defined as: sum itch/pruritus score first 3 days – sum itch/pruritus score last 3 days <2).
- Patients will be able to record appropriately on the patient diary during last 3 days before enrollment day and have more than 80% of recording rate of patient diary in run-in period.
Related-disease inclusion criteria:
For the group of patients with chronic spontaneous urticaria:
Screening:
- Patients with a documented history of chronic spontaneous urticaria for at least 6 weeks prior to consent signature.
Enrollment:
- Patients who have at least 4 (maximum score is 9) for sum of the pruritus score of Urticaria Activity Score (UAS) during last 3 days of run-in period, before enrollment day.
- Patients who have at least 16 (maximum score is 42) for sum UAS during last 7 days (UAS7) before enrollment day.
For group of patients with eczema / dermatitis, prurigo, or cutaneous pruritus:
Screening:
- Patients presenting some of the aforementioned skin diseases.
- Patients who are thought to be appropriate for the inclusion criteria of the enrollment.
Enrollment:
- Patients who have at least 4 (maximum score is 9) for the sum of the Itch Score during last 3 days of run-in period, before enrollment day.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

The following exclusion criteria apply for all patients:
Screening:
S1) Patients with or who have had malignant tumors or patients with severe concomitant diseases including liver disease (liver failure, fulminant hepatitis, cirrhosis, etc.), kidney disease (nephrotic syndrome, acute renal failure, uremia, etc.), thyroid diseases (uncontrolled hyperthyroidism or hypothyroidism), heart disease (congestive cardiac failure, myocardial infarction, sinus tachycardia, atrial fibrillation, atrial flutter, severe arrhythmias, etc.), haematological disease (pancytopenia, leukopenia, etc.), psychiatric/neurological disorders (schizophrenia, dementia, etc.), and autoimmune disease (collagen disorder, etc).
S2) Patients with previous experience of non-response to antihistamines.
S3) Patients with fungal, bacterial or viral skin infections (excluding those that do not interfere with the efficacy evaluation).
S4) Patients with any of the following diseases that may interfere with efficacy evaluation:
?Severe dermographism
?Cholinergic urticaria
?Physical urticaria
?Angiitis or collagen disease induced urticaria
?Paraneoplastic urticaria
?Parasitic urticaria
?Pigmented urticaria
?Schnitzler syndrome
?Cryopyrin associated periodic syndrome (CAPS)
?Psoriasis
S5) Patients with a history of drug allergy for antihistaminic agents, bilastine or ingredients.
S6) Pregnant females or nursing mothers, those intending to get pregnant during the study period, those who do not agree to use contraception during the study period and for 4 weeks after completion of administration of the investigational drug, those who do not agree to or cannot undergo a pregnancy test (excluding those who have entered menopause more than a year ago or are medically incapable of getting pregnant) and males who do not agree to use contraception during the study period and for 4 weeks after completion of administration of the investigational drug.
Enrollment:
E1) Patients who were treated with the following drugs in the 7 days prior to enrollment day (including topical and non-prescription drugs)
Antihistamine drugs (including H2 receptor antagonists and common cold remedies containing antihistamine drugs).
Anti-allergic drugs (thromboxane A2 synthesis inhibitors/receptor antagonists, prostaglandin D2 receptor antagonists, leukotriene receptor antagonists, mediator release inhibitors and Th2 cytokine inhibitors).
Antiplasmin drugs (tranexamic acid, etc.).
Glycyrrhizinate.
Diaminodiphenyl sulfone.
Antipruritic drugs (pregabalin, crotamiton, etc.).
E2) Patients who were treated with the following drugs in the 30 days prior to enrollment day:
Systemic corticosteroids (including depot formulations).
Tacrolimus hydrate.
Immunological drugs (methotrexate, cyclophosphamide, mycophenolate mofetil, omalizumab, etc).
P-glycoprotein (P-gp) inhibitos (ketoconazole, erythromycin, cyclosporine, diltiazem, etc.).
E3) Patients who were treated with any investigational drug in the 90 days prior to enrollment day (including topical drugs).
E4) Patients who met any of the screening’s exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified