Status:
COMPLETED
Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Lead Sponsor:
Galderma R&D
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
- Participant was 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
- 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 \[e.g.\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
- Unilateral lesions of prurigo (e.g., only one arm affected).
- History of or current confounding skin condition (e.g., 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 (e.g., polymerase chain reaction \[PCR\]), or human immunodeficiency virus antibody) at the screening visit.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2023
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT04501666
Start Date
September 11 2020
End Date
February 21 2023
Last Update
July 10 2024
Active Locations (100)
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1
Galderma Investigational Site
Birmingham, Alabama, United States, 35233
2
Galderma Investigational Site
Birmingham, Alabama, United States, 35244
3
Galderma Investigational Site
Los Angeles, California, United States, 90045
4
Galderma Investigational Site
Sacramento, California, United States, 95815