A long-term study to assess the safety and efficacy of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)

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• Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study (individuals re-entering from the phase 3b durability study RD.06.SPR.203890 meeting any of the following criteria at the re-entry Week R0 visit are ineligible): 1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject; 2. Body weight < 30 kg; 3. Having received any of the treatments listed in Table 7 in the protocol within the specified timeframe before the baseline or re-entry Week R0 visit; 4. Pregnant women (positive pregnancy test result at screening, baseline or re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during the clinical study; 5. Any medical or psychological condition that may put the subject at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (eg, poor venous access or needle-phobia); 6. Planning or expected to have a major surgical procedure during the clinical study; 7. Subjects unwilling to refrain from using prohibited medications during the clinical study; 8. History of alcohol or substance abuse within 6 months of the screening or re-entry Week R0 visit.
• For subjects who do not rollover within 28 days from a prior nemolizumab study or who completed study visits but prematurely discontinued study drug, the following exclusion criteria also apply: 9. Subjects with a history of asthma meeting 1 or more of the following criteria: a. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months; b. Reporting asthma that has not been well-controlled (ie, symptoms occurring on >2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months; c. Asthma Control Test (ACT) ≤19 (only for subjects with a history of asthma) at screening and baseline; d. Peak expiratory flow (PEF) <80% of the predicted value. 10. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis; 11. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods, as described in Section 8.4.2 of the protocol. 12. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at screening. 13. Chronic pruritus resulting from another active condition than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (eg, primary biliary cirrhosis), or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care; 14. History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis); 15. Subjects with active atopic dermatitis (signs and symptoms other than dry skin) in the last 3 months; 16. Neuropathic and psychogenic pruritus, such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis; 17. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for: (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the screening visit, or (2) actinic keratoses that have been treated; 18. History of hypersensitivity (including anaphylaxis) to an immunoglobulin (plasma-derived or recombinant) product (eg, monoclonal antibody) or to any of the study drug excipients; 19. Current active or latent tuberculosis (TB) infection or history of either untreated or inadequately treated active or latent TB according to the local applicable guidelines.