E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe atopic dermatitis |
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E.1.1.1 | Medical condition in easily understood language |
Atopic dermatitis (AD), is a type of inflammation of the skin (dermatitis) that results in itchy, red, swollen, and cracked skin |
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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 evaluate the efficacy of MSTT1041A compared with placebo on basis of total Eczema area and severity index (EASI) score |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the efficacy of MSTT1041A compared with placebo on basis of Investigator's global assessment (IGA), EASI-75, Numeric rating scale (NRS), body surface area (BSA) and by SCORing Atopic dermatitis (SCORAD)
•To evaluate the safety of MSTT1041A compared with placebo on the basis of adverse events, vital signs, electrocardiogram (ECG)s, and clinical laboratory results
•To characterize the MSTT1041A pharmacokinetic (PK) profile on the basis of serum concentration
•To evaluate the immune response to MSTT1041A on the basis of anti-drug antibodies (ADAs)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18-75 years
- Ability to comply with the study protocol
- Chronic AD that has been present for at least 3 years before the screening visit
- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
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E.4 | Principal exclusion criteria |
- Prior treatment with MSTT1041A
- Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
- Treatment with investigational or licensed biologics as follows:
Any cell-depleting agents including but not limited to rituximab: within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
Other biologics: within 3 months or 5 half-lives before screening, whichever is longer
- Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- History or evidence of substance abuse that would pose a risk to patient safety, interfere with the conduct of the study, have an impact on the study results, or affect the patient's ability to participate in the study
- History of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the MSTT1041A or placebo injection
- Planned surgical intervention during the course of the study
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Patient who is a member of the investigational team or his/her immediate family
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E.5 End points |
E.5.1 | Primary end point(s) |
1)Percent change from baseline to Week 16 of total EASI score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Baseline (Day 1), Week 16 |
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E.5.2 | Secondary end point(s) |
1)Proportion of patients who achieve IGA response of 0 or 1 (clear or almost clear) at Week 16
2)Proportion of patients who achieve EASI-75 (>= 75% reduction from baseline in EASI score) at Week 16
3)Percent change in pruritus from baseline to Week 16, as assessed by a NRS
4)Percent change in BSA with AD involvement from baseline to Week 16
5)Percent change in disease severity from baseline to Week 16, as assessed by SCORAD
6)Incidence and severity of adverse events
7)Change from randomization visit in vital signs, ECGs, and clinical laboratory results
8)Serum concentrations of MSTT1041A
9)Incidence of treatment-emergent ADAs during the study
10)Potential impact of ADA status on efficacy, safety, and PK endpoints
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-2. Baseline, Week 16
3-5. Baseline, Week 16
6-10. Up to Week 24
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenecity
Predictive Biomarkers |
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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 | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 |
Germany |
Poland |
United States |
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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.8.9.1 | 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 |