A single center, phase I, partially blinded, placebo-controlled, first-in-man study to evaluate the safety, tolerability and Proof of Mechanism (PoM) of a single administration of BFH772 in healthy volunteers, and Proof of Concept (PoC) study to evaluate the safety, tolerability, and pharmacodynamics of multiple topical administrations of BFH772 in patients with psoriasis
- Conditions
- Plaque psoriasisMedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis
- Registration Number
- EUCTR2008-002795-96-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Common inclusion criteria:
- able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Safety cohorts and Part 1 (healthy volunteers)
- Caucasian 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, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the subject has rested for at least 3 minutes, and again when required after 3 minutes in the standing position. Vital signs should be within the following ranges:
Auricular oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-140 mm Hg
diastolic blood pressure, 50-90 mm Hg
pulse rate, 40 - 90 bpm
- Postmenopausal females must have had no regular menstrual bleeding for at least 1 year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >26.72 IU/L at screening.
Female subjects who report surgical sterilization must have had the procedure at least 6 months prior to initial dosing.
- Male subjects must be using highly effective methods of contraception , (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child 1 month following the last study drug administration.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 29 kg/m2.
Part 2 (psoriasis patients)
- Male and female (of non-childbearing potential) patients age 18 to 75 years of age included at the time of the screening visit, having passed screening examinations
- Diagnosis of stable mild to moderate plaque psoriasis; diagnosed or history of psoriasis for at least 6 months prior to screening
- Postmenopausal females must have had no regular menstrual bleeding for at least 1 year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening.
Female subjects who report surgical sterilization must have had the procedure at least 6 months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
- Male subjects must be using highly effective methods of contraception , (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child 1 month following the last study drug administration.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the subject has rested for at least 3 minutes, and again when required after 3 minutes in the standing position. Vital signs should be within the following ranges:
Auricular oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-160 mm Hg
diastolic bloo
Safety cohorts and Part 1 (healthy volunteers)
- Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or OTC medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing. If needed, (i.e. an incidental and limited need) paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
- Participation in any clinical investigation within 4 weeks prior to initial 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 initial dosing, or longer if required by local regulation.
- Significant illness within 2 weeks prior to initial dosing.
- A past medical history of clinically significant ECG abnormalities.
- Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
- Total WBC count which falls outside the range of 4500–11,000/µL (or that of the local laboratory 4400-11300/µL), or platelets <100,000/µL at screening.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and at baseline.
- History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning, sunbeds etc.
Part 2 (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.
- Currently use beta blockers
- Recent previous treatment with anti-TNF therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial:
2 months washout prior to screening for etanercept, adalimumab, efalizumab, infliximab or any other biologic therapy or UVB / PUVA therapy.
1 month washout prior to screening for cyclosporine, mycophenolate, tacrolimus and any systemic immunosuppressants including, but not limited to, methotrexate and azathioprine
- Within 1 month of randomization, received any systemic medications/treatments that could affect psoriasis or PASI evaluation including, but not limited to, oral or injectable corticosteroids, retinoids, vitamin D analogs, psoralins, sulfsalazine, fumaric acid derivatives, or phototherapy.
- Within 1 month of randomization, used topical medications/treatments at the skin sites to be chosen for topical treatment with BFH772 that could affect psoriasis of PASI evaluation including, but not limited to corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives , retinoids, tazarotene, methoxsalen, pimecrolimus, tac
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method