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: 19.0 Level: HLT Classification code 10012435 Term: Dermatitis and ecze
Conditions
Interventions
Trade Name: Bilaxten (for Poland and Spain)
Lendin (for Hungary)
Ayrinal (for Italy)
Pharmaceutical Form: Tablet
INN or Proposed INN: BILASTINA
CAS Number: 202189-78-4
Current Sponsor code: F-96221-BM
Sponsors
FAES FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective will be to evaluate the efficacy of bilastine in the relief of pruritus in patients with chronic spontaneous urticaria or pruritus associated with other skin diseases.;Secondary Objective: Secondary objectives will include the assessment of: - Efficacy in terms of other symptoms and signs of the disease groups - Safety and tolerability of bilastine in terms of adverse events, including ECG and laboratory tests - Quality of life.;Primary end point(s): Primary efficacy variable: Mean change in weekly pruritus/itchy severity score from baseline to week 8;Timepoint(s) of evaluation of this end point: The evaluation will be performed after all patients have been included and the database lock has been performed. The main population for the analysis will be the Full Analysis Set Population. An additional Per Protocol Population with all the subjects of the Full Analysis Set Population who do not perform any major protocol deviation will serve as complementary analysis for the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The evaluation will be performed after all patients have been included and the database lock has been performed.;Secondary end point(s): Patients with chronic spontaneous urticaria: •Mean change in weekly UAS (UAS7) from baseline to week 1, 2, 4 and 8 •Mean change in weekly pruritus severity score from baseline to week 1, 2 and 4 (a,b). •Mean change in weekly VAS for pruritus from baseline to week 1, 2, 4 and 8 (a,b) •Change in daily UAS from baseline (a) •Change in daily wheal and itch from baseline (a) •Change in daily itch from baseline (a) •General improvement factor (reflective) at week 2, 4 and 8 •Change in DLQI from baseline to week 4 and 8 (c) Patients with eczema/dermatitis, prurigo and cutaneous pruritus: •Mean change in weekly itch score from baseline to week 1, 2 and 4 (a,b) •Mean change in weekly VAS for pruritus from baseline to week 1, 2, 4 and 8 (a,b) •Change in daily itch from baseline (a) •Change in investigator’s rash score from baseline to week 2, 4 and 8(c) •General improvement factor (reflective) at week 2, 4 and 8 •Change in DLQI from baseline to week 4 and 8(c) (a) - Baseline: Mean of each symptom score of enrollment day and 3 days prior to enrollment (mean of total 4 days) (b) - Analysis: mean of symptom score at baseline – mean of symptom score for 7 days before each visit. (c) - Analysis: Baseline score on Day 0 – score of each visit Safety endpoints: • Incidence of adverse events (AEs), serious adverse events (SAEs), and related adverse events (rAEs). • Change of various clinical laboratory test results, ECG and vital signs. | — |
Countries
Hungary, Spain
Contacts
Public ContactProject Management
Linical
Outcome results
None listed