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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotest
ClinicalTrials.gov Identifier:
NCT01072383
First received: February 18, 2010
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: BT061
Drug: placebo treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biotest:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose group with the highest number of responders (PASI score improvement) [ Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing ] [ Designated as safety issue: No ]
  • PGA (Physician's global assessment) [ Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing ] [ Designated as safety issue: No ]
  • Itching score [ Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing ] [ Designated as safety issue: No ]
  • DLQI (dermatology life quality index) [ Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing ] [ Designated as safety issue: No ]
  • Differential white blood cell count [ Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing ] [ Designated as safety issue: Yes ]
  • Cytokine profile [ Time Frame: weekly during treatment, then 1 week after last dosing ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BT061
receiving BT061 (active compound)
Drug: BT061
administration of BT061 either intravenous or subcutaneous
Other Name: SC or IV administration of BT061 or placebo
Placebo Comparator: Placebo
receiving a placebo
Drug: placebo treatment
administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
Other Name: SC or IV administration of BT061 or placebo

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072383

Locations
Czech Republic
Dermatologic Clinic
Ostrava, Czech Republic
Dermatologic Clinic Prague II
Prague, Czech Republic
Dermatologic Clinic I
Prague, Czech Republic
Dermatologic Clinic Prague III
Prague, Czech Republic
Dermatologic Clinic
Ústí nad Labem, Czech Republic
Hungary
Dermatologic Clinic
Budapest, Hungary
Dermatologic Clinic
Debrecen, Hungary
Dermatologic Clinic
Miskolc, Hungary
Dermatologic Clinic
Szeged, Hungary
Dermatologic Clinic
Szikszo, Hungary
Dermatologic Clinic
Szolnok, Hungary
Dermatologic Clinic
Szombathely, Hungary
Dermatologic Clinic
Veszprém, Hungary
Sponsors and Collaborators
Biotest
Investigators
Principal Investigator: Lajos Kemény, M.D. Szegedi Tudományegyetem (Study site)
  More Information

No publications provided

Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT01072383     History of Changes
Other Study ID Numbers: 973
Study First Received: February 18, 2010
Last Updated: March 12, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy

Keywords provided by Biotest:
chronic plaque psoriasis
psoriasis vulgaris
autoimmune disease

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 22, 2014