Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Phase 2

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: BT061; Drug: placebo treatment

• Registration Number: NCT01072383
• Lead Sponsor: Biotest

Brief Summary

This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.

Detailed Description

Patients are enrolled into escalating dose levels. Improvement of PASI, physician's global assessment and itching score is evaluated after administration of BT061 or placebo. Safety data are assessed by an independent data and safety monitoring board (DSMB).

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed ≥ 12 months prior to Screening.
• BSA (Body surface area) involvement > 10% for more than 6 months.
• PASI ≥10.
• Age ≥ 18 to ≤ 75 years.
• Body mass index (BMI) of 18-30 kg/m2 with a body weight between 50 and 130 kg.

Exclusion Criteria

• Erythrodermic, guttate or palmar pustular psoriasis (mixed forms may be admissible if chronic plaque psoriasis clearly remains the predominant diagnosis
• Treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of BT061/placebo.
• Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo.
• Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis).
• Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at Screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BT061	BT061	receiving BT061 (active compound)
Placebo	placebo treatment	receiving a placebo

Primary Outcome Measures

Name	Time	Method
Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,	weekly during treatment, then 1 week, 1 month and 3 months after last dosing

Secondary Outcome Measures

Name	Time	Method
Dose group with the highest number of responders (PASI score improvement)	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
PGA (Physician's global assessment)	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Itching score	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
DLQI (dermatology life quality index)	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Physical examination	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Differential white blood cell count	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Cytokine profile	weekly during treatment, then 1 week after last dosing

Trial Locations

Locations (4)

Dermatologic Clinic I; 🇨🇿 Prague, Czech Republic

Dermatologic Clinic Prague II; 🇨🇿 Prague, Czech Republic

Dermatologic Clinic; 🇭🇺 Veszprém, Hungary

Dermatologic Clinic Prague III; 🇨🇿 Prague, Czech Republic