A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis - A study to assess the efficacy and safety of nemolizumab in subjects with prurigo nodularis

Galderma S.A.0 sites240 target enrollmentApril 15, 2020

Overview

No summary available.

Registry

who.int

Start Date

April 15, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Galderma S.A.

•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
•3\. 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;
•4\. 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;
•5\. Female subjects of childbearing potential 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, symptothermal, post\-ovulation methods) and withdrawal are not acceptable methods of contraception;

•1\. Body weight \< 30 kg;
•2\. Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end\-stage renal disease, or cholestatic liver disease (eg, primary biliary cirrhosis);
•3\. Unilateral lesions of prurigo (eg, only one arm affected);
•4\. History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T\-cell lymphoma \[mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis)
•5\. Subjects meeting 1 or more of the following criteria at screening or baseline:
•\- Had an exacerbation of asthma requiring hospitalization in the preceding 12 months;
•\- Reporting asthma that has not been well\-controlled (ie, symptoms occurring on \> 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 \= 19 (only for subjects with a history of asthma)
•\- Peak expiratory flow \< 80% of the predicted value.
•6\. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis;