Clinical Trials List
2020-02-01 - 2021-12-31
Phase III
Recruiting1
Terminated4
ICD-10L28.1
Prurigo nodularis
A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
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Trial Applicant
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Sponsor
Sanofi
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
- Chia-Yu Chu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 洪琡茹 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Dupilumab
Active Ingredient
Dupilumab
Dosage Form
IVT
Dosage
150mg/mL
Endpoints
Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 [ Time Frame: Baseline to Week 12 ]
Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 12
Inclution 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) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and 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 Estimated Number of Participants
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Taiwan
15 participants
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Global
150 participants
