inverse psoriasis MedDRA version: 19.0 Level: LLT Classification code 10063160 Term: Inverse psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: LEO 124249 ointment 30 mg/g
Product Code: LEO 124249
Pharmaceutical Form: Ointment
INN or Proposed INN: NA
CAS Number: 1263774-59-9
Current Sponsor code: LEO 124249
Other descriptive nam
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent prior to any trial specific procedures. 2. Male or female subjects between 18 to 75 years. 3. A diagnosis of stable mild to moderate inverse psoriasis (i.e. axillae, the infra- and intermammary, genital, scrotum, abdominal and retroauricular folds; the intergluteal cleft and perianal skin, in addition to neck or other skin folds). Mild to moderate is defined as having at least score 1 for each individual sign thickness and redness, and total TSS score of at least 5. 4. The total treatment area can be up to 4% BSA (720 cm2). 5. Subjects must have a history of psoriasis, or have psoriasis, or present with characteristic psoriasis leasons elsewhere on the body (including the scalp) at Visit 1 (Screening). 6. Stable inverse psoriasis based on TSS evaluated at Visit 1 (Screening) and at Visit 2 (Start of treatment), which must not differ more than 1 point in any single clinical sign score (redness, scaling and thickness). 7. Except for inverse psoriasis, overall good health including well controlled diseases (e.g. hypertension, diabetes, and thyroid disease) as determined by medical history, physical examination, electrocardiogram (ECG), vital signs (blood pressure, heart rate and body temperature) and clinical laboratory evaluation. 8. Subjects willing and able to follow all the trial procedures and complete the whole trial. 9. Female subjects must be of either: o non-childbearing potential, i.e. post-menopausal for at least one year, or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, o child-bearing potential (including women less than post menopausal for 1 year) provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy. • Female subjects of child-bearing potential (and their male partners) and male subjects (and their female partner of childbearing potential) must be willing to use highly effective methods of contraception (pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Female subjects who are breastfeeding or pregnant. 2. Severe chronic inverse psoriasis, or psoriasis on the body (>30% of BSA). 3. Current diagnosis of acute guttate, erythrodermic, exfoliative or pustular psoriasis. 4. Signs of clinically active infection in any of the inverse psoriasis areas, as judged by the investigator. 5. Disease that has spontaneously and markedly deteriorated or improved between Visit 1 (Screening) and Visit 2 (Start of treatment). 6. Use of biological therapies (marketed/not marketed) with a possible effect on inverse psoriasis within 4 weeks (etanercept), 8 weeks (adalimumab, alefacept, infliximab), 16 weeks (ustekinumab, secukinumab) or 4 weeks/5 half-lives (whichever is longer) for experimental biological products prior to Visit 2 (Start of treatment). 7. Use of systemic treatments (marketed/non-marketed), other than biologics, with a potential effect on inverse psoriasis (e.g., corticosteroids, retinoids, dimethylfumarate, cyclosporine, azathioprine methotrexate, immunosuppressants) within 6 weeks prior to Visit 2 (Start of treatment) (inhaled or intranasal steroids corresponding of up to 1 mg prednisone for asthma or rhinitis may be used). 8. Use of St John’s worth preparations (oral and/or topical) within 2 weeks prior to Visit 2 (Start of treatment). 9. Use of very potent topical corticosteroids (WHO group IV) for the treatment of psoriasis on the body and/or scalp within 4 weeks prior to Visit 2 (Start of treatment). 10. Use of topical medication for the treatment of inverse psoriasis: WHO group I-III corticosteroids, retinoids, vitamin D analogues, immunomodulators (e.g. macrolides, calcineurin), anthracen derivatives, tar, or salicylic acid within 2 weeks prior to Visit 2 (Start of treatment). 11. Exposure to phototherapy (PUVA, UVA, UVB, Grenz Ray therapy) within 4 weeks prior to Visit 2 (Start of treatment). 12. Use of other treatment (drug/non-drug) for inverse psoriasis during the trial, except for the use of IP. 13. Initiation of, or expected changes to concomitant medication, that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to Visit 2 (Start of treatment). 14. Subjects with a positive HBV score antibody, HBsAg, anti-HCV or anti-HIV test at Visit 1 (Screening) . 15. Subjects with history of an immunocompromising disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome). 16. A marked abnormal ECG, i.e. PR interval > 220 ms, QRS interval >110 ms or corrected QT interval (Bazett, QTcB) > 470 ms for females and > 450 ms for males at Visit 1 (Screening). 17. Supine BP that is over 150/95 mmHg or below 90/50 mmHg at Visits 1 (Screening) and 2 (Start of treatment). 18. Supine heart rate that is over 100 beats per minute (bpm) or below 50 bpm at Visits 1 (Screening) and 2 (Start of treatment). 19. Body temperature (ear, tympanic) >37.5 ºC or 2 times the upper limit of normal) . 21. History of concurrent diseases that could interfere with study evaluations or pose a safety concern. 22. Any current dermatological disorder (e.g. serborrhic dermatitis, contact dermatitis, cutaneous mycosos) which may confound the evaluation of inverse psoriasis. 23. Know
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of twice daily application of LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle for 6 weeks in the treatment of subjects with mild to moderate inverse psoriasis.;Secondary Objective: To compare the safety and tolerability of twice daily application of LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle for 6 weeks in the treatment of subjects with mild to moderate inverse psoriasis.;Primary end point(s): The total sign score (TSS = sum of scores for redness, thickness, and scaliness of inverse psoriasis, each scored from 0 to 4, total sum from 0 to 12) at Week 6.;Timepoint(s) of evaluation of this end point: at end of treatment (V6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit t6 (Week 6). 2. Score for clinical sign thickness for inverse psoriasis (score 0 to 4) at Visit 6 (Week 6). 3. Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6). 4. Size of treatment area of inverse psoriasis at Visit 6 (Week 6). 5. Physicians Global Assessment of disease severity (PGA) at Visit 6 (Week 6). 6. Patients Global Assessment of disease severity (PaGA) Visit 6 (Week 6). 7. Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6). 8. Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6). 9. For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6) (Subjects classified as having at least ‘moderate’ disease at baseline who achieve ‘clear’ or ‘almost clear’ disease severity will be considered to have ‘controlled disease. Subjects classified at baseline as having ‘mild’ disease must achieve ‘clear’ to be considered to have ‘controlled disease’). 10. For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6) (Subjects classified as having at least ‘moderate’ disease at baseline who achieve ‘clear’ or ‘almost clear’ disease severity will be considered to have ‘controlled disease. Subjects classified at baseline as having ‘mild’ disease must achieve ‘clear’ to be considered to have ‘controlled disease’). ;Timepoint(s) of evaluation of this end point: at end of treatment (V6) | — |
Countries
Germany
Contacts
Public ContactAnnika Kullberg
LEO Pharma A/S
Outcome results
None listed