Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Neurodermatitis
About this trial
This is an interventional treatment trial for Neurodermatitis
Eligibility Criteria
Inclusion Criteria:
Must be 18 to 80 years of age, at the time of signing the informed consent.
With a clinical diagnosis of PN defined by all of the following:
- Diagnosed by a dermatologist for at least 3 months before the Screening visit
- On the WI-NRS ranging from 0 to 10, patients must have an average worst itch score of ≥7 in the 7 days prior to Day1.
- Patients must have a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at Screening visit and Day 1
- History of failing a 2-week course of medium-to-superpotent topical corticosteroids (TCS) or when TCS are not medically advisable
- Have applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1
- Must be willing and able to complete a daily symptom eDiary for the duration of the study
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes
- PN secondary to medications
- PN secondary to medical conditions such as neuropathy or psychiatric disease
- Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit
- Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study
- Severe renal conditions (eg, patients with uremia and/or on dialysis)
- Participants with uncontrolled thyroid disease.
- Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated
- Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
- Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period
- Known or suspected immunodeficiency
- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number :8400011
- Investigational Site Number :8400022
- Investigational Site Number :8400026
- Investigational Site Number :8400014
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- Investigational Site Number :1560004
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- Investigational Site Number :6430008
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- Investigational Site Number :6430005
- Investigational Site Number :6430010
- Investigational Site Number :6430006
- Investigational Site Number :6430009
- Investigational Site Number :6430002
- Investigational Site Number :6430001
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dupilumab
Placebo
Participants received dupilumab at a loading dose of 600 milligrams (mg), subcutaneously (SC) on Day 1 followed by dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.