Plaque psoriasis MedDRA version: 17.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: M518101 Ointment (pefcalcitol)
Product Code: M518101
Pharmaceutical Form: Ointment
INN or Proposed INN: Pefcalcitol
CAS Number: 381212-03-9
Current Sponsor code: M5181
Concentration unit
Sponsors
Maruho Europe Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a patient in this trial: 1.Male or female patients aged 18 years or older on the day of signing the ICF; 2.Signed and dated ICF obtained prior to any trial related activities; 3.Clinical diagnosis of stable plaque psoriasis of at least 6 months duration (involving the trunk, limbs, palms and/or feet); 4.Patients who have up to 20% BSA affected with plaques at V1 (screening) and V2 (Wk0-D1) (BSA calculation should not include face/scalp but should include palms of hands and soles of feet); 5.Patients who are assessed as moderate or severe in IGA at V1 (screening) and V2 (Wk0-D1) and who are suitable for topical therapy; 6.Women of childbearing potential (less than post-menopausal for two years) should have a negative pregnancy test (serum) at V1 (screening); 7.Sexually active female patients of childbearing potential (less than post-menopausal for two years), must agree to use documented means of effective birth control (such as oral, transdermal, injectable or implanted hormonal contraceptives; intrauterine device, diaphragm with spermicide, use of a condom by the sexual partner or sterile sexual partner) during the course of the treatment phase; local requirements on contraception are to be followed; 8.Patients who have at least one psoriatic plaque (minimum size: 10 cm2 in area) of which PSI total score >= 12 (on trunk, arms or legs) at V1 (screening) and V2 (Wk0-D1); 9.Patients who are capable of understanding and willing to give signed informed consent prior to any protocol specific procedure and are able to complete the trial and comply with protocol instructions. 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 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Patients are to be excluded from the trial, when one or more of the following conditions are met: 1.Patients with known allergic reactions, irritations or sensitivity to the active ingredients (history or presence of allergy to vitamin D3 derivatives or presence of relevant drug hypersensitivity) or other components of the investigational products; 2.Patients who test positive for HIV Ag/Ab, HBs-Ag or HCV-Ab at V1 (screening); 3.Patients 65 years old or older with serum creatinine levels exceeding the upper limit of reference range at V1 (screening); 4.Patients who have any renal (serum creatinine level > 1.5 times above the upper limit of reference range) or liver insufficiency (alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase level > 2.5 fold above upper limit of reference range), or clinically significant cardiac, renal or hepatic disease at V1 (screening); 5.Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial; 6.Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination (including vital signs), ECG, or clinical laboratory safety tests; 7.Patients whose calcium test at V1 (screening) exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone); 8.Subjects who have at least one of the three QTcF measurements at screening of > 450 msec as shown on the ECG; 9.Patients who have used M5181 (active ingredient of M518101); 10.Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization V2 (Wk0-D1); 11.Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization (V2), the longest documented half-life of the biologic should be used to calculate the 5 half-lives; 12.Patients who have been treated with phototherapy (e.g. PUVA, ultraviolet A [UVA], ultraviolet B [UVB]), laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization V2 (Wk0-D1); 13.Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo, see section 5.4.7) or salicylic acid within 14 days of randomization V2 (Wk0-D1); 14.Patients treated with medicines which are known to worsen psoriasis (lithium, beta-blockers and chloroquine), except when the patient is on stable dosing with stable psoriatic condition for more than 12 weeks before the day of randomization and remains on stable dose throughout the trial; 15.Patients who are taking oral vitamin D supplement, except when the patients have been on a stable dose (up to 2,000 IU per day allowed) for at least 56 days (8 weeks) before the day of randomization and plan to continue the dose for the duration of the trial; 16.Patients taking medicines that affect calcium metabolism (e.g. any oral prescription Vitamin D derivatives, calcium preparations, bisphosphonate, thiazide diuretics or hormone preparation exce
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial is designed with two sequentially assessed primary objectives as described in the EMA guideline (Points to consider on switching between superiority and non-inferiority. EMA, July 2000). For the first stage, the primary objective is to demonstrate that M518101 is non-inferior to Daivonex® in % reduction in mPASI and success rate based on IGA. If non-inferiority is demonstrated, the analysis will proceed to the second stage, which is to demonstrate that M518101 is more effective than Daivonex® in the same endpoints. In addition, superiority to Vehicle for both M518101 and Daivonex® will be tested for the same endpoints. ;Secondary Objective: not applicable;Primary end point(s): Primary endpoints -% reduction in mPASI at V7 (Wk8-D57) compared to baseline -Success rate based on IGA at V7(Wk8-D57) ;Timepoint(s) of evaluation of this end point: - V7(Wk8-D57) compared to baseline (Visit 2 / Week 0 / Day 1) - V7(Wk8-D57) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints -mPASI50 rate at V7 (Wk8-D57) -mPASI75 rate at V7 (Wk8-D57) -Change in psoriasis severity index (PSI) total score at V7 (Wk8-D57) compared to baseline -% reduction in mPASI at V2 (Wk1-D8) compared to baseline ;Timepoint(s) of evaluation of this end point: - Visit 7 (Week 8 / Day 57) - Visit 7 (Week 8 / Day 57) compared to baseline (Visit 2 / Week 0 / Day 1) - Visit 2 (Week 1 / Day 8) compared to baseline (Visit 2 / Week 0 / Day 1) | — |
Countries
Austria, Bulgaria, Germany, Hungary, Lithuania, Poland, Romania, Ukraine
Contacts
Public ContactProject Manager
Appletree Clinical Investigations Kft.
Outcome results
None listed