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 |
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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 | 18.0 |
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 effect of MEDI9929 compared with placebo in adult subjects with moderate to severe AD, assessed using the change from baseline in EASI at Week 12. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of MEDI9929 on the efficacy measure of IGA
2. To evaluate the effect of MEDI9929 on the efficacy measure of SCORAD
3. To evaluate the effect of MEDI9929 on patient-reported outcome (PRO) measures of pruritus assessed
using a NRS and 5-D Pruritus Scale
4. To evaluate the safety and tolerability of MEDI9929
5. To characterize the pharmacokinetics (PK) and immunogenicity of MEDI9929 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18-75 years
- clinical diagnosis of atopic dermatitis
- Current disease state meeting the Hanifin and Rajka, 1980 criteria for AD
- Atopic dermatitis involvement of ≥ 10% body surface area at Visit 1 assessed by EASI
- IGA score of ≥ 3 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- EASI score of ≥ 12 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- SCORAD of ≥ 20 at Visit 1 (Screening)
- Effective birth control in line with protocol details |
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E.4 | Principal exclusion criteria |
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant or breastfeeding women
- History of cancer
- Previous receipt of biologic agents within 4 month prior to visit 3 (week 0, day 1) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Fifty percent reduction from baseline in EASI score (EASI 50) at Week 12. |
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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) |
- IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline score
- Change from baseline in EASI
- 75% reduction from baseline in EASI score (EASI 75)
- Change from baseline in SCORAD
- 50% reduction from baseline in SCORAD (SCORAD 50)
- 75% reduction from baseline in SCORAD (SCORAD 75)
- Change from baseline in pruritus
- Safety and tolerability
- Pharmacokinetics and Immunogenicity
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoints will be measured up to Week 12 for on-therapy effects and time points beyond end of treatment for off-therapy effects. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | 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 | 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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 |
Australia |
Canada |
Germany |
Hungary |
New Zealand |
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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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |