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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037084 |
E.1.2 | Term | Prurigo nodularis |
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 |
The primary objective is to assess the efficacy of nemolizumab compared to placebo in the treatment of pruritus in patients suffering from PN. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
1- Efficacy and safety:
Evaluation of the safety of nemolizumab compared to its placebo in patients with PN.
Evaluation of the efficacy of nemolizumab compared to its placebo in the treatment of prurigo lesions in patients with PN.
Evaluation of nemolizumab effect compared to its placebo on quality of life in patients with PN
2-Pharmacokinetics (PK)
Characterization of nemolizumab PK profile and exposure response relationship in patients with PN
3-Pharmacodynamics (PD)
Evaluation of the effect of nemolizumab on biomarkers in patients with PN
4-Biophysical (exploratory)
Evaluation of the efficacy of nemolizumab on scratching events and sleep improvement using actigraphy
Evaluation of the efficacy of nemolizumab on lesions improvement using whole body images device only on equipped sites. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female of at least 18 years at screening
2. Clinical diagnosis of PN for at least 6 months with:
- Prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs
- At least 20 nodules on the entire body with a bilateral distribution
3. Severe pruritus defined as follows on a Numerical Rating Scale (NRS)
- At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous 3 days
- At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous week;
NOTE: NRS score should be measured on at least 5 days during the week preceding the baseline visit.
4. Female subjects must fulfill one of the criteria below:
- Female subjects of non-childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy);
- Female subjects of childbearing potential who agree to a true abstinence (when in line with the preferred and usual lifestyle
of the subject), or to use an effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration |
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E.4 | Principal exclusion criteria |
1. Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
2. Unilateral lesions of prurigo (e.g only one arm affected)
3. Cutaneous bacterial or viral infection within 1 week before the baseline visit.
4. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively,
5. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at significant risk according to Investigator’s judgment (e.g. solid cancer, AIDS, serious or uncontrolled cardiac disease…) at Screening or Baseline.
NOTE: Patients with controlled diseases such as diabetes mellitus, thyroid disorders and psychiatric disorders (such as depression and anxiety) are eligible
6. Any active dermatoses that would need immediate therapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pourcent change in NRS (weekly average of the peak) |
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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- Absolute and Percent change in weekly average of the peak and average pruritus NRS
2- Change of VRS
3- DPS
4- PAS: Distribution for item 6 (excoriation/crusts and healed lesions stages) and change from baseline for item 5 (in lesions number)
5- IGA: Distribution score and success rate (defined as IGA=0[clear] or IGA=1[Almost clear] with two point improvement from baseline).
Other end points:
- Quality of life (DLQI)
- Objective assessments of scratching and sleep by Actigraphy
- Sleep disturbance NRS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- at each visit from baseline
2- from baseline at each time point
3- recorded 24, 48 and 72 hours after the first injection and at week 4 before the injection
4- from baseline to week 18
5- from baseline to week 18 |
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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 | Yes |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 |
Austria |
France |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |