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)

Launched by SANOFI · Dec 2, 2019

Keywords

ClinConnect Summary

The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

Gender

ALL

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 worst-Itch Numeric Rating Scale (WI-NRS) ranged from 0 to 10, participants who had an average worst itch score of greater than or equal to (\>=) 7 in the 7 days prior to Day 1.
• • Participants who had 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 TCS or when TCS were not medically advisable.
• • Had 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.
• • Was willing and abled to complete a daily symptom electronic-diary for the duration of the study.
• Exclusion Criteria:
• Participants were excluded from the study if any of the following criteria apply:
• • Presence of skin morbidities other than PN and mild atopic dermatitis (AD) that interfered 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 participant's participation in the study.
• • Severe renal conditions (eg, participants 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 had ruled out active infection before randomization.
• • Active chronic or acute infection (except human immunodeficiency virus infection) required 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.