A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

  • STATUS
    Recruiting
  • End date
    Oct 31, 2021
  • participants needed
    270
  • sponsor
    Galderma R&D
Updated on 16 January 2021
Investigator
Galderma R&D
Primary Contact
Galderma Investigational Site (7.1 mi away) Contact
+64 other location

Summary

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.

Details
Treatment Placebo, Nemolizumab
Clinical Study IdentifierNCT04501679
SponsorGalderma R&D
Last Modified on16 January 2021

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Prurigo Nodularis??
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 and 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
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
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 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Exclusion Criteria

Body weight less than (<) 30 kg
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 (example [eg] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
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
Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis
Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit
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