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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028703 |
E.1.2 | Term | Nail psoriasis |
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 |
The primary objective of this study is to evaluate the safety and efficacy of adalimumab for treatment of nail psoriasis. |
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E.2.2 | Secondary objectives of the trial |
The study is also designed to evaluate the pharmacokinetics and safety of adalimumab in subjects with nail psoriasis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult subjects with clinical diagnosis of chronic plaque psoriasis (with a disease duration of at least 6 months) and at least 1 fingernail with nail psoriasis.
2. Subject must have BSA ≥ 10% and a target fingernail mNAPSI ≥ 8 at Baseline, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Baseline
3. Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain NRS score of >3
4. Subject must have a Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and and Physician's Global Assessment of Skin Psoriasis (PGA-S) of at least moderate.
5. Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Baseline. Ustekinumamb must have been discontinued at least 12 weeks prior to Baseline.
6. NAPSI score of >0 from the proximal half of subject’s target fingernail. |
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E.4 | Principal exclusion criteria |
1. Prior adalimumab therapy.
2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis
3. Recent infection requiring treatment
4. Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse
5. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
6. History of cancer, except successfully treated skin cancer |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ranked primary efficacy endpoints in the order at which statistical analysis will be conducted:
1. Proportion of subjects achieving a total-fingernail mNAPSI 75 response, defined as at least a 75%
reduction in total mNAPSI of all fingernails relative to Baseline at Week 26.
2. Proportion of subjects with PGA-F of "clear" or "minimal" at Week 26. |
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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) |
Ranked secondary efficacy endpoints in the order at which statistical analysis will be conducted:
1. Percent change from Baseline in total NAPSI of all fingernails at Week 26.
2. Proportion of subjects achieving mNAPSI = 0 in all fingernails at Week 26.
3. Change from Baseline in Nail Ps Pain Numeric Rating Scale (NRS) at Week 26.
4. Change from Baseline in Nail Ps Physical Functioning Severity score at Week 26.
5. Change from Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life
(NAPPA QoL) at Week 26. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Belgium |
Canada |
France |
Germany |
Greece |
Mexico |
United Kingdom |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |