| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Patients with stable plaque type psoriasis (sufficient number and size of psoriatic plaques(s) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Patients with plaque psoriasis |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To assess efficacy and safety of MC2-01 formulations in patients with stable plaque psoriasis.
Primary Objective is to investigate the efficacyď€ of MC2-01 (calcipotriol + BDP) compared
• to MC2-01 (calcipotriol)
• to MC2-01 vehicle control
in the treatment of stable plaque psoriasis assessed by TCS. |
|
| E.2.2 | Secondary objectives of the trial |
Secondary objectives are to investigate efficacy of MC2-01 (calcipotriol + BDP) compared to
• MC2-01 (BDP)
and the marketed reference products
• Daivobet® Ointment and
• Daivobet® Gel
in the treatment of stable plaque psoriasis assessed by TCS and to evaluate the safety of the IPs by means of
• occurrence of SAEs/AEs |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. The written informed consent form (ICF) has been signed and dated by the patient prior to any study-related activity.
2. Male or female subjects aged 18 years or above.
3. Willingness to actively participate in the study and to comply with the study procedures as defined in the study protocol.
4. High probability of a good compliance and orderly completion of the study.
5. Female subjects of childbearing potential must use a highly effective method of contraception .
6. Negative urine pregnancy test (in female subjects with childbearing potential).
7. Subjects with in the opinion of the investigator, stable psoriasis vulgaris plaque(s) evaluated at Screening Visit.
8. Stable psoriasis at Baseline Visit (Day 1) assessed by a Total Clinical Score (TCS; sum of scores of erythe-ma, scaling and infiltration) of 5 to 12 (scores for ery-thema and infiltration>2, and scaling > 1, respectively).
9. Target plaque(s) included must be located on corre-sponding parts of the body (e.g. either both arms, both upper legs, both lower legs, or trunk). Sum of target plaque(s) (not more than 2) must have a total size suitable for application of 6 different products. Chosen plaques must be comparable in intensity of psoriasis symptoms at investigator’s discretion.
|
|
| E.4 | Principal exclusion criteria |
1. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
2. Females who are pregnant, lactating, or who wish to become pregnant during the study.
3. Any disease or circumstances on account of which the subject should not participate in the study in the opinion of the investigator.
4. Systemic treatment with biological therapies (market-ed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks /5 half-lives (which-ever is longer) for experimental biological products prior to randomization and during the study.
5. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomization and during the study.
6. Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomization and during the study:
• Potent or very potent (WHO group III-IV) corti-costeroids
• PUVA
7. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to ran-domization and during the study:
• WHO group I corticoids (except if used for treatment of scalp and/or facial psoriasis) and WHO group II corticosteroids
• Tar (except if used for treatment of scalp and/or facial psoriasis)
• Dithranol (except if used for treatment of scalp and/or facial psoriasis)
• Salicylic acid (except if used for treatment of scalp and/or facial psoriasis)
• Topical retinoids
• Vitamin D analogues
• Topical immunomodulators (e.g. macrolides)
• Anthracen derivatives
• UVB therapy
8. Subjects using emollients on the target plaques within one week before randomization and during the study.
9. Initiation of, or expected changes to concomitant med-ication that may affect psoriasis vulgaris (e.g. beta blockers, anti-malaria drugs, lithium and ACE inhibi-tors) within 2 weeks prior to the randomization and during the study.
10. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following reg-istration) within the 4 week period prior to randomiza-tion or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments).
11. Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the IP(s) or the ingredients of the products.
12. Any chronic disease that may affect the absorption, metabolism or elimination of the IP(s).
13. Subjects with known/suspected disorders of calcium metabolism based on medical history.
14. History of any severe disease or serious current con-dition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency).
15. Subjects with any concomitant medical or dermatolog-ical disorder(s) which might preclude accurate evalua-tion of the psoriasis on the test areas.
16. Subjects in the following conditions on/near the target plaques: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections without suitable concomitant anti-infective therapy, parasitic infections, skin manifestations in relation to tuberculosis or syphi-lis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.
17. Subjects with moles, tattoos, pigmentation or scars in the target plaques that would influence TCS scoring.
18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the Screening Visit.
19. Any suspicion of drug and/or alcohol abuse.
20. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
21. Employee of the study site or of the Sponsor’s com-pany.
22. Current participation in any other clinical study and 30 days before Screening Visit.
23. Earlier participation in the treatment phase of the study.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 1 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
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