A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis

Biotest4 sites in 2 countries49 target enrollmentFebruary 2010

ConditionsPsoriasis Vulgaris

InterventionsBT061 placebo treatment

DrugsBT061 placebo treatment

Overview

Phase: Phase 2
Intervention: BT061
Conditions: Psoriasis Vulgaris
Sponsor: Biotest
Enrollment: 49
Locations: 4
Primary Endpoint: Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

August 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotest

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

Arms & Interventions

BT061

receiving BT061 (active compound)

Intervention: BT061

Placebo

receiving a placebo

Intervention: placebo treatment

Outcomes

Primary Outcomes

Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,

Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing

Secondary Outcomes

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)