E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eczema/dermatitis and the dermal pruritus (itchy skin disease) |
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E.1.1.1 | Medical condition in easily understood language |
Eczema/dermatitis and the dermal pruritus (itchy skin disease) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012431 |
E.1.2 | Term | Dermatitis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014184 |
E.1.2 | Term | Eczema |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037090 |
E.1.2 | Term | Pruritus cutaneous |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
1. To evaluate the efficacy of MK-4117 for the eczema/dermatitis and dermal pruritus groups using the change from Baseline in pruritus/itch score (sum of daytime and nighttime scores) assessed by (sub-) investigator at Week 2.
2. To evaluate the safety and tolerability of MK-4117 5 mg and 10 mg (increased dose) administered once daily for 8 to 12 weeks to the eczema/dermatitis and to the dermal pruritus groups.
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of MK-4117 when administered to subjects in eczema/dermatitis and dermal pruritus groups using the change from baseline in pruritus/itch score (sum of daytime and nighttime scores) assessed by (sub-) investigator after 3 days, 1 week, 4 weeks, 6 weeks, 8 weeks and 12 weeks of treatment.
2. To evaluate the efficacy of MK-4117 when administered to subjects in eczema/dermatitis and dermal pruritus groups using the improvement rate (proportion of moderate and marked improvement) in global improvement rate assessed by (sub-) investigator after 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks of treatment.
3. To evaluate the efficacy of MK-4117 when administered to subjects in eczema/dermatitis and dermal pruritus groups using the change from baseline in the degree of pruritus recorded by subjects (VAS [visual analogue scale ] [100 mm]) after 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks of treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Visit 1 / Screening
1. Subject with eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate) and subject with dermal pruritus (generalized dermal pruritus, localized dermal pruritus) [Subject expected to meet the inclusion criteria #6 at Visit 2, based on pruritus/itching score].
2. Subject who can make entries in the subject diary or have a legal representative who can make entries
3. Subject is 12 years and older when informed consent is given
4. Subject is a male, or a female who is unlikely to conceive, as indicated by at least one “yes” answer to the following questions: (a) Subject is a surgically sterilized female (hysterectomy, ligation of both fallopian tubes, or oophorectomy of both sides) (b) Subject reached natural menopause (defined as ≥12 months of spontaneous amenorrhea in woman ≥46 years of age) (c) Subject is of reproductive potential and agrees to (1) remain abstinent or (2) use (or have her partner use) 2 adequate barrier methods of contraception to prevent pregnancy within the projected duration of the study (from giving written informed consent) and for 14 days after the last dose of study medication. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom (male partner), vasectomy (male partner), hormonal contraceptives.
5. Subject who could understand the study objective and procedure, and has the ability to give informed assent/consent (informed assent and informed consent must also be obtained from a minor subject and legal representative, respectively, in the case of minors) before the study.
Visit 2/ Week 0/ at randomization
6. Subject having symptoms to a degree allowing the evaluation of the study drug. Based on the criteria specified in the protocol, subject who was judged severity of dermatological symptoms by (sub-) investigator. The subjects with score 2 or above for the sum of daytime and nighttime scores can be enrolled in this study.
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E.4 | Principal exclusion criteria |
Visit 1 / Screening
1. Subject for whom the period of discontinuation of previous treatment before the start of study drug administration indicated in the protocol is not adequate.
2. Subject with a history of hypersensitivity to antihistamines or ingredients of study drug.
3. Subject who is currently receiving treatment with another study drug or has received a study drug in the past 3 months.
4. Subject who needs prohibited drugs
5. Subject with severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor (assessed as grade 3 by Japanese Adverse Reaction criteria).
6. Subject has a history of malignancy or clinically important hematological disorder.
7. Subject has a history of severe drug allergy (e.g., anaphylactoid reaction).
8. Pregnant or lactating woman or woman who may be pregnant.
9. Subject has one or more of the following laboratory abnormalities.
a) AST and/or ALT >2 fold above the ULN
b) Serum creatinine >1.5 mg/dL in male and >1.3 mg/dL in female.
c) Positive pregnancy test (Urinary hCG) in females who may be potential to be pregnant.
10. Subject is mentally or legally incompetent to give written consent to participate in the study.
11. Subject is judged inappropriate for study by the (sub-) investigator.
Visit 2/ Week 0/ at randomization
12. Subject for whom the period of discontinuation of previous treatment before the start of study drug administration indicated in the protocol is not adequate.
13. Patient has a positive pregnancy test (Urinary hCG) at Visit 2.
14. Subject is judged inappropriate for study by the (sub-) investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: Change from Baseline in pruritus/itch score (sum of daytime and nighttime scores) assessed by (sub-) investigator at Week 2;
Safety: Percentage of subjects with adverse experiences; and Change from baseline in laboratory parameters at each visit. Baseline is defined as the evaluation at Visit 2.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At week 2 and at each visit. |
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E.5.2 | Secondary end point(s) |
1.) Change from baseline in pruritus/itch score (sum of daytime and nighttime scores) assessed by (sub-) investigator after 3 days, 1 week, 4 weeks, 6 weeks, 8 weeks and 12 weeks of treatment;
2.) Proportion of moderate and marked improvement in global improvement rate assessed by (sub-) investigator after 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks of treatment; and
3.) Change from baseline in the degree of pruritus recorded by subjects (VAS [visual analogue scale ] [100 mm]) after 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks of treatment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks |
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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 | Yes |
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
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 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial months | 11 |