PsoriasisPhase 1NCT00417820
Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.
A Phase 1 study testing BCT194 in people with Psoriasis, run by Novartis at 1 site in Austria.
Trial summary
The purpose of this study is to assess the local tolerability of a single topical administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety, tolerability, and efficacy of a multiple topical administrations in patients with psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- BCT194
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2006to Nov 2007
- Phase
- Phase 1
- 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
- All participants:
- Healthy male and female (of non-childbearing potential) subjects age 18 to 45 years of age included, and in good health as determined by past medical history Postmenopausal women must have had no regular menstrual bleeding for at least 1 year prior to inclusion or female subjects must have been surgically sterilized at least 6 months prior to screening supported by clinical documentation.
- Male subjects must be using a double-barrier local contraception.
- Body weight must be between 50 and 100kg (inclusive) to participate in this study
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- Psoriasis patients:
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- Diagnosis of stable plaque psoriasis with or without arthritis for at least 6 months prior to screening.
- Absence of clinically relevant abnormalities for screening laboratory test results of hematological (hemoglobin, white blood cells, neutrophils, platelets), renal (serum creatinine) and hepatic (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gammaglutamyltransferase,bilirubin) parameters.
- Willingness to avoid sunbeds or unusual sun exposure during the study period.
Who cannot join
- All participants:
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable,
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
- A past personal or close family medical history of clinically significant cardiac abnormalities
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- History of:
- Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
- Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
- Known hypersensitivity or severe adverse event to darifenacin or similar drugs
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study
- Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result
- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- Drug or alcohol abuse within the 6 months prior to dosing.
- History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks prior to study start, including tanning, sunbeds etc.
- Psoriasis patients:
- Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Used any investigational drug within the previous 4 weeks.
- Recent previous treatment with anti-TNF-α therapy (or other biological therapy),immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-Blind, Placebo Controlled Exploratory Study to Evaluate the Safety, Tolerability and Pharmacodynamics of a Single Administration of BCT194 in Healthy Volunteers and Multiple Administrations in Patients With Psoriasis.
The purpose of this study is to assess the local tolerability of a single topical administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety, tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.
- Conditions
- Psoriasis
- Being tested
- BCT194
- Keywords
- Safety, tolerability, pharmacodynamics, single administration, BCT194, healthy volunteers, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCT194Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability
Efficacy as assessed by plaque Psoriasis Area and Severity Index (PASI) scoring at 4 weeks
Secondary outcomes (3)
Potential of absorption of topical BCT194 into the systemic circulation and to determine skin exposure
Cellular changes in psoriasis skin by immunohistology at day 8
Changes in HSP-27 and phospho (p) HSP-27 in protein lysates of skin biopsies at Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startNov 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417820
- Sponsor's protocol ID
- CBCT194A2101
- Status last verified
- Nov 2007
- First submitted
- 3 Jan 2007
- Last updated
- 29 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Placebo Controlled Exploratory Study to Evaluate the Safety, Tolerability and Pharmacodynamics of a Single Administration of BCT194 in Healthy Volunteers and Multiple Administrations in Patients With Psoriasis.
- ClinicalTrials.gov ID
- NCT00417820
- Acronym / sponsor ID
- CBCT194A2101
- Conditions
- Psoriasis
- Keywords
- Safety, tolerability, pharmacodynamics, single administration, BCT194, healthy volunteers, psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 4 Jan 2007 (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.
The purpose of this study is to assess the local tolerability of a single topical administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety, tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy male and female (of non-childbearing potential) subjects age 18 to 45 years of age included, and in good health as determined by past medical history Postmenopausal women must have had no regular menstrual bleeding for at least 1 year prior to inclusion or female subjects must have been surgically sterilized at least 6 months prior to screening supported by clinical documentation.
- Male subjects must be using a double-barrier local contraception.
- Body weight must be between 50 and 100kg (inclusive) to participate in this study
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- Diagnosis of stable plaque psoriasis with or without arthritis for at least 6 months prior to screening.
Key exclusion criteria (21 listed)
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable,
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
- A past personal or close family medical history of clinically significant cardiac abnormalities
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 |
|---|---|---|
| BCT194 | Drug | – |
Primary outcome
Safety & tolerability
Efficacy as assessed by plaque Psoriasis Area and Severity Index (PASI) scoring at 4 weeks
3 secondary outcomes
Potential of absorption of topical BCT194 into the systemic circulation and to determine skin exposure
Cellular changes in psoriasis skin by immunohistology at day 8
Changes in HSP-27 and phospho (p) HSP-27 in protein lysates of skin biopsies at Day 8
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 29 Nov 2007.
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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.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCT194 in people with Psoriasis, run by Novartis at 1 site in Austria.
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 9 inclusion and 21 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 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety & tolerability. The study lists 2 primary outcomes in all. 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 29 Nov 2007.