chronic plaque-type psoriasis (psoriasis vulgaris) MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: Bimosiamose 5% Cream
Pharmaceutical Form: Cream
Other descriptive name: Bimosiamose
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-
Pharmaceutical form
Sponsors
Revotar Biopharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a patient with chronic plaque type psoriasis into the study: 1. Male patients or postmenopausal female patients with amenorrhea of at least twelve consecutive months duration prior to screening (medical certificate by gynecologist) or sterile female patients with documented hysterectomy or tubal ligation 2. PASI score of 5-15 (plaques must not be exclusively over the knees and elbows) and a PGA of = moderate 3. At least 18 years of age 4. Time and ability to complete the study and comply with instructions 5. Written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients are to be excluded from the study when one or more of the following conditions are met: 1. Active skin infection or other skin conditions that may influence the evaluation of the psoriatic lesions e.g. eczema 2. More than 20% Body Surface Area (BSA) affected by psoriasis (excluding palmar or plantar located) 3. Use of anti-psoriasis medication or treatments below (except emollients): a. Retinoid, calcipotriene, coal tar or anthralin =14 days prior to Baseline b. Systemic and topical corticosteroids, fumarate, methotrexate, cyclosporine or systemic retinoids, =30 days prior to Baseline c. Prolonged sun exposure =30 days prior to Baseline d. Laser therapy or Photodynamic therapy (or PUVA) =30 days prior to Baseline e. Etanercept, efalizumab, infliximab or adalimumab =90 days prior to Baseline f. Alefacept or IL-12/23 inhibitors =180 days prior to Baseline g. On lithium, antimalarials, beta blockers or ACE inhibitors unless the dose has been stable for 60 days prior to entry and is planned to remain stable during the study 4. Clinical study participation with any investigational drug less than 90 days prior to study entry or planning to receive an investigational drug during the study period 5. Previous treatment with Bimosiamose 6. Known allergy to any of the components of Bimosiamose 5% Cream 7. Cancerous or pre-cancerous lesions 8. Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to stay in the study for 140 days because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable; or patients who have a concomitant condition that might confuse or confound study assessments) 9. Severe allergies manifested by a history of anaphylaxis or a history of multiple allergies 10. Receiving immunosuppressive therapy 11. Positive results on urine drug screen 12. Current signs of alcohol abuse 13. The patient has laboratory test results that indicates acute or chronic infectious hepatitis A, B or C or an infection with human immunodeficiency virus (HIV) 14. gamma-GT =3 times the upper limit of normal 15. Platelet count =10% below the lower limit of normal 16. Subject is institutionalized because of legal or regulatory order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is the evaluation of the safety and efficacy of topical Bimosiamose 5% Cream for the treatment of male and postmenopausal or sterile female patients with mild to moderate chronic plaque type psoriasis. Clinical efficacy will be assessed by the improvement from Baseline of modified Psoriasis Area and Severity Index by 50% (mPASI 50, PASI excluding the scalp) at Day 112 (End of Treatment) in patients treated with Bimosiamose 5% Cream compared with Placebo Cream.;Secondary Objective: • To assess the global effect of Bimosiamose treatment on psoriasis over the study period • To assess the induration, erythema, scaling and pruritus in two Index Lesions over the study period • To assess the time to effective treatment • To determine patient satisfaction with Bimosiamose treatment • To assess the potential for rebound effects of treatment ;Primary end point(s): Improvement from Baseline of modified Psoriasis Area and Severity Index by 50% (mPASI 50) at week 16 (End of Treatment) in patients treated with Bimosiamose 5% Cream compared with Placebo Cream. mPASI is the full PASI score minus the scalp component. | — |
Countries
Germany
Outcome results
None listed