Multi-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of Bimosiamose 5% Cream for the treatment of patients with chronic plaque type psoriasis - Psoriasis POC

• Conditions: chronic plaque-type psoriasis (psoriasis vulgaris); MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2008-000197-20-DE
• Lead Sponsor: Revotar Biopharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-07
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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