Moderate to Severe Plaque Psoriasis MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Kalcypotriol
Kalsipotriol
Kalsipotrioli
Kalcipotriol
MC-903
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 52.2 microg/g-(as hydrate)
INN or Proposed INN: betamethasone dipropionate
CAS Number: 22298-29-9
Other desc
Betametasona, benzoato de
Bétaméthasone, Benzoate de
W-5975
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.643-
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Topical us
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is = 18 years of age. 2. Subject has a diagnosis of chronic plaque psoriasis with disease duration of at least 6 months since diagnosis. Subjects with concomitant psoriasis palmaris and plantaris will be permitted into this study. 3. Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA. 4. Subject must fulfill at least two of the following three Psoriasis severity criteria: ? PASI = 10 ? Affected Body Surface Area (BSA) = 10% ? Dermatology Life Quality Index (DLQI) = 10 5. Female subject is either not of childbearing potential, defined as postmenopausal (at least one year since last menses) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion. ? Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) ? Contraceptives (oral, parenteral, patch) for three months prior to study drug administration) ? A vasectomized partner 6. Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at Baseline. 7. Subject is judged to be in good general health by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, CXR, and 12-lead electrocardiogram (ECG) performed at Screening. 8. Subject must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections. 9. Subject has voluntarily signed and dated an informed consent form prior to any study related procedure and is willing to comply with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 10. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at screening. If the subject had a positive PPD test (or equivalent) and/or CXR (PA and/or lateral view), the subject must have had one of the following: ? Prophylactic treatment initiated prior to administration of study drug; however the course of prophylaxis need not be completed prior to the onset of study drug. Prophylactic treatment will be according to Appendix D (United States Centers for Disease Control [CDC] recommended preventive therapy for TB) or per local guidelines as approved by the Abbott Study Physician. ? Subject has documented prophylactic treatment for TB in the past and does not need to repeat this treatment or TB prophylaxis is ongoing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has previous exposure to adalimumab. 2. Subject has been treated with systemic corticosteroids (oral or parenteral) 4 weeks (28 days) or topical corticosteroids 2 weeks (14 days) prior to Baseline. Inhaled corticosteroids for stable medical conditions are allowed. 3. Subject received topical treatment with calcipotriol or calcipotriol/betamethasone (Daivobet®) within 2 weeks (14 days) prior to Baseline. 4. Subject with known overexposure to PUVA or UVB. 5. Subject received a previous biologic agent within the following washout period: ? Etanercept received 2x the upper limit of normal (ULN). ? Serum total bilirubin = 1.5 mg/dL (= 26 micromol/L) 18. Subjects with known hypersensitivity to the constituents of study drugs (adalimumab, calcipotriol/betamethasone, or matching vehicle). 19. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis. ;Secondary Objective: Not applicable.;Primary end point(s): The comparison of the proportion of subjects with a PASI75 at Week 16 Arm 1 (adalimumab + calcipotriol/ betamethasone) vs. Arm 2 (adalimumab + vehicle calcipotriol/betamethasone). | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed