E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis also known as Eczema |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
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 test the hypothesis that baricitinib 4 mg QD + Topical Corticosteroids or baricitinib 2 mg QD + Topical Corticosteroids is superior to placebo + Topical Corticosteroids in the treatment of patients with moderate to severe AD. |
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E.2.2 | Secondary objectives of the trial |
-To compare the efficacy of baricitinib 2 mg QD + Topical Corticosteroids or baricitinib 4 mg QD + Topical Corticosteroids to placebo + Topical Corticosteroids in AD during the 16 week double blind placebo controlled treatment period as measured by improvement in signs and symptoms of AD.
-To compare the efficacy of baricitinib 2 mg QD + Topical Corticosteroids or baricitinib 4 mg QD + Topical Corticosteroids to placebo + Topical Corticosteroids in AD during the 16 week double blind placebo controlled treatment period as assessed by patient reported outcome measures.
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-At least 18 years of age.
-Have a diagnosis of AD at least 12 months prior to screening, as defined
by the American Academy of Dermatology
-Have moderate to severe AD, including all of the following:
a. Eczema Area and Severity Index (EASI) score ≥16
b. IGA score of ≥3
c. ≥10% of BSA involvement
-Have a documented history by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening, or history of intolerance to topical therapy.
-Are male or nonpregnant, nonbreastfeeding female patients. Male patients, and female patients of childbearing potential, must agree to use a reliable method of birth control during the study and for at least 4 weeks following the last dose of investigational product. |
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E.4 | Principal exclusion criteria |
-Have other concomitant skin conditions that would interfere with evaluations of the effect of study medication
-Have had an important side effect to Topical Corticosteroids (e.g., intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects), as assessed by the investigator or treating physician that would prevent further use.
-Are currently experiencing or have a history of erythrodermic,refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections that may interfere with participation in the study.
-Skin infection that requires treatment with topical or systemic antibiotics.
-Serious concomitant illness
-Are immunocompromised and at an unacceptable risk for participating in the study.
-Have a clinically serious viral, bacterial, fungal, or parasitic infection
-Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study.
-Have evidence of active TB or latent TB
-Have evidence of HBV, HCV or HIV infection |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving IGA of 0 or 1 with a ≥2 point improvement |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of patients achieving EASI75
2. Proportion of patients achieving EASI90
3. Percent change from baseline in EASI score
4. Proportion of patients achieving SCORAD75
5.Mean change from baseline in the score of Item 2 of the ADSS
6.Mean change from baseline in Skin Pain NRS
7.Proportions of patients achieving a 4 point improvement in Itch NRS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoint 1 to 6 only at week 16
Endpoint 7 at week 1, week 2, week 4 and week 16 |
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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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Germany |
Italy |
Japan |
Korea, Republic of |
Poland |
Spain |
Taiwan |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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LVLS: End of the study is the date of the last visit or last scheduled
procedure shown in the Schedule of Activities for the last patient. |
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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 | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 4 |