E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
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 effectiveness of pimecrolimus cream 1% in Atopic Dermatitis (AD)
disease control over 36 months and the effect of early use of pimecrolimus cream
1% in reducing the incidence of asthma at 6 years of age |
|
E.2.2 | Secondary objectives of the trial |
• To investigate the safety of Elidel cream in the long-term management of AD in infants and
young children
• To evaluate the efficacy and safety of early use of the Elidel cream in reducing the
incidence of allergic rhinitis, allergic conjunctivitis, and food allergies
• To assess the effect of the Elidel-LTM on CS use and Elidel drug consumption
• To investigate the effect on AD remission time of Elidel-LTM
• To evaluate parents’/caregivers’ quality of life (QoL) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diagnosis of atopic dermatitis
• Family history of atopy
• 3 to 18 months of age at baseline
At least mild atopic dermatitis at baseline (investigator global
assessment [IGA] greater or equal to 2)
• Clinical evidence of atopic dermatitis for no longer than 3 months |
|
E.4 | Principal exclusion criteria |
• Diagnosis of or substantial clinical evidence for food or other allergies
at baseline |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: (Primary 1) AD disease control over 36 months
(Primary 2) Effect on reducing incidence of asthma at 6
years of age - Results not reported |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary 1: 36 months
Primary 2: 6 years |
|
E.5.2 | Secondary end point(s) |
Long-term safety in infants and young children (Time frame: 6 years)
o Results not reported
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
o Percentage of patients at 36 months and 6 years with allergies
Corticosteroid and Pimecrolimus Drug use (Time frame: 48 months)
o CS and Pimecrolimus medication days of exposure
AD Remission time (Time frame: 36 month Double-Blind Phase)
o Longest duration of AD remission during 36 month double-blind treatment phase
Patient/Caregiver Quality of Life (Time frame: from baseline to visit 5, 6, 8, 10,
12, and 14)
o Change from baseline in total Parents' Index of Quality of Life-Atopic Dermatitis
(PIQoL-AD) score in double-blind phase |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Various, listed next to individual end points |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 20 |