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)

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Calcineurin Inhibitors

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) 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.