Prurigo nodularis MedDRA version: 20.0 Level: LLT Classification code 10037084 Term: Prurigo nodularis System Organ Class: 100000004858
Conditions
Interventions
Product Name: CD14152 100mg powder (Nemolizumab)
Product Code: CD14152
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Nemolizumab
Current Sponsor code: CD1415
Sponsors
GALDERMA R&D, SNC
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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.;Primary end point(s): Pourcent change in NRS (weekly average of the peak);Timepoint(s) of evaluation of this end point: From baseline to week 4;Main Objective: The primary objective is to assess the efficacy of nemolizumab compared to placebo in the treatment of pruritus in patients suffering from PN. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Austria, France, Germany, Poland, United States
Contacts
Public ContactRA CTA Coordinator
GALDERMA R&D, SNC
Outcome results
None listed