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)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Neurodermatitis

Treatments: Drug: Topical calcineurin inhibitors; Drug: Low to medium potent topical corticosteroids; Drug: Moisturizers; Drug: Dupilumab SAR231893; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04202679

EFC16460

2019-003801-90

U1111-1241-8174 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.

Treatment:

Drug: Placebo

Drug: Topical calcineurin inhibitors

Drug: Low to medium potent topical corticosteroids

Drug: Moisturizers

Dupilumab 300 mg Q2W

Experimental group

Description:

Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.

Treatment:

Drug: Dupilumab SAR231893

Drug: Topical calcineurin inhibitors

Drug: Low to medium potent topical corticosteroids

Drug: Moisturizers