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

Completed · Phase 3 · Has a placebo group

Conditions studied: Prurigo Nodularis

In brief

The primary objective was 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.

Key facts

Study ID

NCT04501679

Run by

Galderma R&D

People needed

274

Starts

2020-08-11

Expected to finish

2022-03-31

Last updated by the study team

2024-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits
• Severe pruritus was defined as follows on the PP NRS:
• At the screening visit (Visit 1): PP NRS score was >= 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 was >= 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

You may not qualify if…

• 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
• 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

Where it is running

• Galderma Investigational Site — San Diego, California, United States
• Galderma Investigational Site — Washington D.C., District of Columbia, United States
• Galderma Investigational Site — Aventura, Florida, United States
• Galderma Investigational Site — Miami, Florida, United States
• Galderma Investigational Site — North Miami Beach, Florida, United States
• Galderma Investigational Site — Ormond Beach, Florida, United States
• Galderma Investigational Site — Chicago, Illinois, United States
• Galderma Investigational Site — Indianapolis, Indiana, United States
• Galderma Investigational Site — Louisville, Kentucky, United States
• Galderma Investigational Site — Boston, Massachusetts, United States
• Galderma Investigational Site — Saint Joseph, Michigan, United States
• Galderma Investigational Site — New York, New York, United States
• Galderma Investigational Site — Cincinnati, Ohio, United States
• Galderma Investigational Site — Dublin, Ohio, United States
• Galderma Investigational Site — Anderson, South Carolina, United States
• Galderma Investigational Site — Murfreesboro, Tennessee, United States
• Galderma Investigational Site — Dallas, Texas, United States
• Galderma Investigational Site — Dripping Springs, Texas, United States
• Galderma Investigational Site — Pflugerville, Texas, United States
• Galderma Investigational Site — Webster, Texas, United States
• Galderma Investigational Site — Morgantown, West Virginia, United States
• Galderma Investigational Site — Brussels, Belgium
• Galderma Investigational Site — Ghent, Belgium
• Galderma Investigational Site — Jette, Belgium
• Galderma Investigational Site — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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