Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

Primary Objective: To demonstrate the efficacy of dupilumab on itch response in patients with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in patients with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable To demonstrate efficacy of dupilumab on skin lesions of PN To demonstrate the improvement in health-related quality of life To evaluate safety outcome measures To evaluate immunogenicity of dupilumab

Official Title

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

Details

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

Keywords

Neurodermatitis Prurigo Calcineurin Inhibitors Dupilumab SAR231893 Moisturizers Low to medium potent topical corticosteroids Topical calcineurin inhibitors Dupilumab

Eligibility

You can join if…

Open to people ages 18-80

:

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

You CAN'T join if...

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 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 above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations

  • Investigational Site Number 8400026
    Sacramento California 95816 United States
  • Investigational Site Number 8400011
    Gilbert Arizona 85234 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
Sign up for this study
ID
NCT04183335
Phase
Phase 3
Study Type
Interventional
Last Updated