Prurigo Nodularis MedDRA version: 20.0 Level: LLT Classification code 10037084 Term: Prurigo nodularis System Organ Class: 100000004858
Conditions
Sponsors
Galderma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female and aged =18 years at the time of screening; 2. Clinical diagnosis of PN for at least 6 months with: • Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs; • At least 20 nodules on the entire body with a bilateral distribution • IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits 3. Severe pruritus defined as follows on the PP NRS: • At the screening visit (Visit 1): PP NRS score is = 7.0 for the 24-hour period immediately preceding the screening visit; • At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is = 7.0 over the previous week; 4. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below: • True abstinence, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, XML File Identifier: F2dK24HaFCzSCkafRlDZXM3i8qY= Page 11/26 symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; • Progestogen-only oral hormonal contraception; • Combination of male condom with cap, diaphragm, or sponge with spermicide (double barrier methods) (*In Germany only, double barrier methods are not considered a highly effective method of contraception) ; Note: "Double barrier methods" refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (eg, condom) together with a spermicide is not acceptable. • Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception; • Injectable or implanted hormonal contraception; • Intrauterine devices or intrauterine hormone-releasing system; • Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study; • Bilateral vasectomy of male partner at least 3 months before the study 5. Female subjects of non-childbearing potential must meet 1 of the following criteria: • Absence of menstrual bleeding for 1 year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range; • Documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months before the study; 6. Subject is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the subject using an electronic handheld device provided for this study. 7. Read, understood and signed an informed consent form (ICF) before any investigational procedure(s) are performed. 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 223 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 47
Exclusion criteria
Exclusion criteria: 1. Body weight 2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months; - Asthma Control Test (ACT) = 19 (only for subjects with a history of asthma) - Peak expiratory flow (PEF) < 80% of the predicted value. 6. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis; 7. Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral or parenteral antibiotics, XML File Identifier: F2dK24HaFCzSCkafRlDZXM3i8qY= Page 12/26 antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods, as described in Section 8.4.2; 8. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C [HCV] antibody with positive confirmatory test for HCV [eg, polymerase chain reaction (PCR)], or human immunodeficiency virus antibody) at the screening visit; 9. Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit; 10. Subjects with active atopic dermatitis (signs and symptoms other than dry skin) in the last 3 months; 11. Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis; 12. Having received any of the treatments in the table reported in the protocol within the specified timeframe before the baseline visit; 13. Previous participation in a clinical study with nemolizumab; 14. Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study; 15. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for: - Basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the screening visit, or; -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy and safety of nemolizumab (CD14152) compared to placebo in subjects = 18 years of age with PN after a 16 week treatment period.;Secondary Objective: The secondary objectives are to assess the safety, pharmacokinetics, and immunogenicity of nemolizumab (CD14152) compared to placebo.;Primary end point(s): - Proportion of subjects with an improvement of = 4 from baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16. - Proportion of subjects with an Investigator Global Assessment (IGA) success (defined as an IGA of 0 [Clear] or 1 [Almost clear] and a = 2-point improvement from baseline) at Week 16; ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoints: - Proportion of subjects with an improvement of = 4 from baseline in PP NRS at Week 4; - Proportion of subjects with PP NRS < 2 at Week 16. - Proportion of subjects with an improvement of = 4 from baseline in SD NRS at Week 16; - Proportion of subjects with an improvement of = 4 from baseline in SD NRS at Week 4; - Proportion of subjects with PP NRS < 2 at Week 4 Secondary Efficacy Endpoints: - IGA success rate at each visit through Week 16; - IGA score at each visit through Week 16; - Percentage of pruriginous lesions with excoriations/crusts (Prurigo Activity Score [PAS] item 5a) at each visit through Week 16; - Percentage of healed prurigo lesions (PAS item 5b) at each visit through Week 16; - Change from baseline in number of lesions in representative area (PAS item 4) at each visit through Week 16; - Proportion of subjects with an improvement of = 4 from baseline in PP NRS through Week 16; - Proportion of subjects with PP NRS < 2 from baseline through Week 16; - Proportion of subjects with PP NRS < 3 from baseline through Week 16; - Absolute change from baseline in PP NRS through Week 16; - Percent change from baseline in PP NRS through Week 16; - Proportion of subjects with an improvement of = 4 from baseline in AP NRS through Week 16; - Proportion of subjects with AP NRS < 2 from baseline through Week 16; - Absolute change from baseline in AP NRS through Week 16; - Percent change from baseline in AP NRS through Week 16; - Proportion of subjects with an improvement of = 4 from baseline in SD NRS through Week 16; - Absolute change from baseline in SD NRS through Week 16; - Percent change from baseline in SD NRS through Week 16; - Change from baseline in sleep diary endpoints (sleep onset latency, wakefulness after sleep onset [WASO], total awake time, total sleep time, sleep efficiency, WASO related to PN, number of WASO related to PN) based on recordings from subje | — |
Countries
Belgium, Canada, France, Netherlands, Poland, Spain, Switzerland, United States
Contacts
Public ContactClinical Trial Information Desk
Galderma S.A.
Outcome results
None listed