Clinical trial NCT01072383: Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: chronic plaque psoriasis
psoriasis vulgaris
autoimmune disease
Lead sponsor: Biotest
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.
* 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.

Primary outcomes:
measure: Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Secondary outcomes:
measure: Dose group with the highest number of responders (PASI score improvement)
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
measure: PGA (Physician's global assessment)
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
measure: Itching score
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
measure: DLQI (dermatology life quality index)
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
measure: Physical examination
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
measure: Differential white blood cell count
timeFrame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
measure: Cytokine profile
timeFrame: weekly during treatment, then 1 week after last dosing
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Dermatologic Clinic
city: Prague
country: Czech Republic
facility: Dermatologic Clinic I
city: Prague
country: Czech Republic
facility: Dermatologic Clinic Prague III
city: Prague
country: Czech Republic
facility: Dermatologic Clinic Prague II
city: Ústí nad Labem
country: Czech Republic
facility: Dermatologic Clinic
city: Budapest
country: Hungary
facility: Dermatologic Clinic
city: Debrecen
country: Hungary
facility: Dermatologic Clinic
city: Miskolc
country: Hungary
facility: Dermatologic Clinic
city: Szeged
country: Hungary
facility: Dermatologic Clinic
city: Szikszo
country: Hungary
facility: Dermatologic Clinic
city: Szolnok
country: Hungary
facility: Dermatologic Clinic
city: Szombathely
country: Hungary
facility: Dermatologic Clinic
city: Veszprém
country: Hungary
facility: Dermatologic Clinic
Study officials:
affiliation: Szegedi Tudományegyetem (Study site)
name: Lajos Kemény, M.D.
role: PRINCIPAL_INVESTIGATOR
References: