E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive Psoriasis Vulgaris |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 100000004858 |
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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 evaluate the effect of MC2-01 cream on the HPA axis and calcium metabolism following once daily topical application under maximum-use conditions in subjects with extensive psoriasis vulgaris. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the pharmacokinetic profile of the active ingredients and their main metabolites following once daily topical application of MC2-01 cream under maximum-use conditions in adolescent subjects (age 12 to 16 years, 11 months) with extensive psoriasis vulgaris. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The parent(s), or legal guardian(s)have provided written informed consent.
The subject has provided written assent to the trial.
Healthy males or non-pregnant females, who are between 12 to 16 years, 11-month-old.
Clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months, with or without scalp
Treatment area between 10% and 30% of the BSA on the body and scalp
At least moderate severity on the treatment area
Normal HPA axis function
Serum albumin-corrected calcium below the upper reference limit at SV2
Negative urine pregnancy test for WOCP and use of a highly effective method of contraception |
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E.4 | Principal exclusion criteria |
Unstable forms of psoriasis
Other inflammatory skin disease in the treatment area
Presence of pigmentation or extensive scarring in the treatment area
Use of phototherapy within 4 weeks prior to inclusion
Current or past history of disorders of calcium metabolism
Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin
Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors and inducers
Use of topical treatments for Psoriasis 2 weeks prior to inclusion
Systemic treatment with biological therapies for Psoriasis
Use of systemic medication that suppresses the immune system
Use of life vaccines
Known allergic asthma or serious allergies
Skin infections
Known human immunodeficiency virus (HIV) infection
Known or suspected of hypersensitivity to any component of the test product or reference product
Any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject
Females who are pregnant, breast feeding, or planning a pregnancy
Participation in another clinical trial or received an IP or non-marketed drug substance within 30 days
Previously enrolled in this trial
Subject is unlikely to comply with the clinical trial protocol in the opinion of the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
HPA axis: The assessment of HPA axis suppression and of changes in calcium metabolism are the primary endpoints in this trial. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 4 and Week 8 of treatment |
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E.5.2 | Secondary end point(s) |
Plasma PK parameters
Adverse Events
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Plasma PK: week 4 of treatment
Adverse Events: after treatment has finished |
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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) | No |
E.8.2.2 | Placebo | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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
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|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |