An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

  • End date
    Dec 31, 2021
  • participants needed
  • sponsor
    Galderma R&D
Updated on 20 September 2021
Galderma R&D
Primary Contact
Galderma Investigational Site (3.1 mi away) Contact
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The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.

Condition Prurigo Nodularis
Treatment Placebo, Nemolizumab 30 mg
Clinical Study IdentifierNCT04501666
SponsorGalderma R&D
Last Modified on20 September 2021


Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of PN for at least 6 months with: (a) Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs; (b) At least 20 nodules on the entire body with a bilateral distribution; (c) Investigator Global Assessment (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
Severe pruritus defined as follows on the PP NRS: (a) at the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit; (b) at the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is >= 7.0 over the previous week
Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
Participant 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 participant using an electronic handheld device provided for this study

Exclusion Criteria

Body weight < 30 kilogram (kg)
Unilateral lesions of prurigo (eg, only one arm affected)
History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis)
Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
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
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