A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Inclusion Criteria:

• Age ≥ 18 years (or any legal adult age within the country if it is older than 18years)

• Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.

• Patient-reported average Daily Itch Score based on electronic daily diary assessmentthe last 7 days prior to and including day 1.

• Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legsand /or arms and /or trunk.

• History of inadequate response to topical therapies of medium or higher potency orfor whom topical treatments are otherwise medically inadvisable (eg, because ofimportant side effects or safety risks).

Exclusion Criteria:

• Skin or systemic morbidities, other than prurigo nodularis, that have been activewithin the last 3 months that interfere with assessment of study outcomes includingbut not limited to atopic dermatitis (signs or symptoms other than dry skin orrequiring treatment is not allowed; use of emollients and/or history of AD isallowed).

• Prurigo nodularis secondary to medications.

• Prurigo nodularis secondary to neurologic or psychiatric medical conditions.

• Treatment with any systemic biologic immunosuppressive or systemic biologicimmunomodulatory therapy for prurigo nodularis or any other autoimmune,inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever islonger, prior to day 1 prerandomization.

• Treatment with live virus including live attenuated vaccination 12 weeks prior today 1 prerandomization.