NCT01072383

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

February 18, 2010

Last Update Submit

March 12, 2012

Conditions

Psoriasis Vulgaris

Keywords

chronic plaque psoriasispsoriasis vulgarisautoimmune disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

BT061

EXPERIMENTAL

receiving BT061 (active compound)

Drug: BT061

Placebo

PLACEBO COMPARATOR

receiving a placebo

Drug: placebo treatment

Interventions

BT061DRUG

administration of BT061 either intravenous or subcutaneous

Also known as: SC or IV administration of BT061 or placebo
BT061
placebo treatmentDRUG

administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous

Also known as: SC or IV administration of BT061 or placebo
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Dermatologic Clinic

Ostrava, Czechia

Location

Dermatologic Clinic I

Prague, Czechia

Location

Dermatologic Clinic Prague III

Prague, Czechia

Location

Dermatologic Clinic Prague II

Prague, Czechia

Location

Dermatologic Clinic

Ústí nad Labem, Czechia

Location

Dermatologic Clinic

Budapest, Hungary

Location

Dermatologic Clinic

Debrecen, Hungary

Location

Dermatologic Clinic

Miskolc, Hungary

Location

Dermatologic Clinic

Szeged, Hungary

Location

Dermatologic Clinic

Szikszó, Hungary

Location

Dermatologic Clinic

Szolnok, Hungary

Location

Dermatologic Clinic

Szombathely, Hungary

Location

Dermatologic Clinic

Veszprém, Hungary

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Lajos Kemény, M.D.

    Szegedi Tudományegyetem (Study site)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 22, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

CZ(5)HU(8)