Psoriasis VulgarisPhase 2NCT01072383
Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing BT061 in people with Psoriasis Vulgaris, run by Biotest at 13 sites in 2 countries.
Trial summary
This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- BT061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Feb 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Hungary8 sites
Dermatologic Clinic
Budapest
Dermatologic Clinic
Debrecen
Dermatologic Clinic
Miskolc
Dermatologic Clinic
Szeged
Dermatologic Clinic
Szikszó
Dermatologic Clinic
Szolnok
Dermatologic Clinic
Szombathely
Dermatologic Clinic
Veszprém
Czechia5 sites
Dermatologic Clinic
Ostrava
Dermatologic Clinic I
Prague
Dermatologic Clinic Prague III
Prague
Dermatologic Clinic Prague II
Prague
Dermatologic Clinic
Ústí nad Labem
About this study
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
This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.
Read the 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).
- Conditions
- Psoriasis Vulgaris
- Being tested
- BT061, placebo treatment
- Keywords
- chronic plaque psoriasis, psoriasis vulgaris, autoimmune disease
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT061Drug
Also called SC or IV administration of BT061 or placebo
administration of BT061 either intravenous or subcutaneous
placebo treatmentDrug
Also called SC or IV administration of BT061 or placebo
administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
| Study group | Role | What they receive |
|---|---|---|
| BT061 | Experimental | receiving BT061 (active compound) Receives: Drug: BT061 |
| Placebo | Placebo comparator | receiving a placebo Receives: Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
Measured: 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)
Measured: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
PGA (Physician's global assessment)
Measured: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Itching score
Measured: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
DLQI (dermatology life quality index)
Measured: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Physical examination
Measured: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Differential white blood cell count
Measured: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Cytokine profile
Measured: weekly during treatment, then 1 week after last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lajos Kemény, M.D., Principal investigator, Szegedi Tudományegyetem (Study site)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072383
- Sponsor's protocol ID
- 973
- Status last verified
- Mar 2012
- First submitted
- 18 Feb 2010
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01072383
- Acronym / sponsor ID
- 973
- Conditions
- Psoriasis Vulgaris
- Keywords
- chronic plaque psoriasis, psoriasis vulgaris, autoimmune disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BiotestIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BT061 | Experimental | Drug: BT061receiving BT061 (active compound) |
| Placebo | Placebo comparator | Drug: placebo treatmentreceiving a placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT061Also: SC or IV administration of BT061 or placeboadministration of BT061 either intravenous or subcutaneous | Drug | BT061 |
| placebo treatmentAlso: SC or IV administration of BT061 or placeboadministration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
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
PGA (Physician's global assessment)
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Itching score
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
DLQI (dermatology life quality index)
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Physical examination
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Differential white blood cell count
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Cytokine profile
Time frame: weekly during treatment, then 1 week after last dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lajos Kemény, M.D. principal investigator
Szegedi Tudományegyetem (Study site)
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BT061 in people with Psoriasis Vulgaris, run by Biotest at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Hungary, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.