Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)

Inclusion Criteria:

• Participant must be 18 (or the legal age of consent in the jurisdiction in which thestudy is taking place) to 90 years of age inclusive, at the time of signing theinformed consent.

• Participants with chronic pruritus for at least 6 months before the screening visit.

• Chronic pruritus considered of unknown origin as assessed by the investigator atbaseline (excluding chronic pruritus secondary to dermatological or systemicconditions, of neuropathic or psychogenic origin or secondary to drugs).

• Chronic pruritus must affect at least 2 of the following body areas: legs, arms, ortrunk.

• History of insufficient control of the chronic pruritus with prior treatment.

• Participants should receive optimal treatment for concomitant conditions that couldimpact pruritus (eg, diabetes, iron deficiency).

• Participants must have a history of severe itch and a worst itch score of ≥7 atscreening on the WI-NRS (score scale ranges from 0 to 10; higher score indicatesworse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening.

• Participants must have an average worst itch score of ≥7 in the 7 days prior torun-in visit and in the 7 days prior to Day 1 on the WI-NRS.

• Participants scored "severe" in the PGIS of pruritus on Day 1.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Severe concomitant illness(es) that, in the Investigator's judgment, would adverselyaffect the patient's participation in the study.

• Patients with active tuberculosis or non-tuberculous mycobacterial infection, or ahistory of incompletely treated tuberculosis, unless it is well documented by aspecialist that the participant has been adequately treated and can now starttreatment with a biologic agent.

• Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or useof antiparasitic drug within 2 weeks before the screening visit.

• HIV infection.

• Severe renal failure (dialysis).

• Active chronic or acute infection requiring treatment with systemic antibiotics,antivirals, or antifungals within 2 weeks before the run-in visit.

• 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 and completely treated andresolved non metastatic squamous or basal cell carcinoma of the skin.

• History of hypersensitivity or intolerance to non-sedative antihistamines.

• Participation in prior dupilumab clinical study or have been treated withcommercially available dupilumab.

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