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Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

NCT04202679

CompletedPhase 3

Sponsor: Sanofi

Conditions: Neurodermatitis

Interventions: Dupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors

Countries: United States, Canada, Chile, France, Hungary, Italy, Portugal, South Korea

Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants 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 participants 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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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) ranging from 0 to 10, participants must have an average worst itch score of \>=7 in the 7 days prior to Day1.
* Participants 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 were 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 atopic dermatitis 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 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 above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (57)
  • Fort Smith, Arkansas, United States
  • Sacramento, California, United States
  • Pembroke Pines, Florida, United States
  • Plainfield, Indiana, United States
  • Baltimore, Maryland, United States
  • East Windsor, New Jersey, United States
  • Sugar Land, Texas, United States
  • Calgary, Alberta, Canada
  • Surrey, British Columbia, Canada
  • Markham, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Toronto, Ontario, Canada
  • Saskatoon, Saskatchewan, Canada
  • Valdivia, Los Ríos Region, Chile
  • Osorno, Reg Metropolitana de Santiago, Chile
  • Santiago, Reg Metropolitana de Santiago, Chile
  • Santiago, Reg Metropolitana de Santiago, Chile
  • Santiago, Reg Metropolitana de Santiago, Chile
  • Santiago, Chile
  • Bordeaux, France
  • Brest, France
  • Le Mans, France
  • Lille, France
  • Lyon, France
  • Paris, France
  • Reims, France
  • Toulouse, France
  • Debrecen, Hungary
  • Orosháza, Hungary
  • Pécs, Hungary
  • + 27 more on CT.gov