To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

Inclusion Criteria:

1. Participants aged >= 18 years at the screening visit.

2. Had end-stage kidney disease (ESKD) and had been on hemodialysis three times perweek for at least three months prior to the start of screening. Note 1: Participants who required an occasional additional hemodialysis treatment tomanage fluid overload might be enrolled as long as it was anticipated that no morethan one such treatment would be required in any given week. Note 2: Participants had received in-home hemodialysis might participated as long asthey had switched to in-center hemodialysis at least two weeks prior to screeningand plan to remain on in-center hemodialysis for the duration of the study.

3. Hemodialysis participants meeting the Kidney Outcome Quality Initiative Guidelinesof hemodialysis adequacy within 60 days of screening, two:

•Single-poolsKt/V measurements of at least 1.2.

4. Pruritus for >= three months (documented pruritus with no etiology identified otherthan CKD by medical record, previous physician's letter/statement, or a writtenconversation of site investigators based on the medical history obtained from theparticipant).

5. WI NRS score >= 5.0 at the screening and baseline visit. Screening WI NRS scorewould be determined by a single WI NRS assessment (score ranging from 0 to 10) forthe 24-hour period immediately preceding the screening visit. Baseline WI NRS scorewould be determined based on the weekly average of daily WI NRS scores (scoreranging from 0 to 10) during the seven days immediately preceding baseline (roundingwas not permitted). A minimum of four daily scores out of the seven days immediatelypreceding baseline was required for this calculation.

6. Women of childbearing potential (WOCBP) (i.e., fertile, following menarche and untilbecoming post-menopausal unless permanently sterile) must agreed either to commit totrue abstinence throughout the study and for 12 weeks after the last study druginjection, when this was in line with the preferred and usual lifestyle of theparticipant, or to use an adequate and approved method of contraception throughoutthe study and for 12 weeks after the last study injection. Adequate and approved methods of contraception applicable for the participant and/orher partner were defined below:

• Progestogen-only oral hormonal contraception.

• Combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods).

• Combined (estrogen- and progestogen-containing) oral, intravaginal, ortransdermal hormonal contraception.

• Injectable or implanted hormonal contraception.

• Intrauterine devices or intrauterine hormone releasing system.

• Bilateral tubal ligation or tube insert (such as the Essure system) at leastthree months before the study.

• Bilateral vasectomy of partner at least three months before the study.

7. Women were considered to be of non-childbearing potential if they meet one of thefollowing criteria:

• Absence of menstrual bleeding for one year prior to screening without any othermedical reason, confirmed with follicle stimulating hormone (FSH) level in thepostmenopausal range.

• Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy atleast three months before screening. Note: Bilateral tubal ligation was not accepted as reason for non-childbearingpotential.

8. Participant was willing and able to comply with all time commitments and proceduralrequirements of the clinical study protocol.

9. Understands and signs an informed consent form (ICF) before any investigationalprocedure(s) were performed.

Exclusion Criteria:

1. Body weight less than (<) 30 kg.

2. Pruritus caused by a concomitant condition unrelated to ESKD (e.g., dermatologic orsystemic disorders such as, but not limited to atopic dermatitis (AD), psoriasis,prurigo nodularis (PN), Chronic T- cell Lymphoma, Leukemia or cholestatic liverdisease).

3. Localized itch of only the palms of the hands and/or soles of the feet.

4. Pruritus present only during hemodialysis session.

5. History of or anticipated non-compliance with hemodialysis (i.e, such that it wouldadversely affect the conduct of the study or significantly change dialysis adequacyduring the study) in the opinion of the investigator.

6. New York Heart Association Class IV symptoms or myocardial infarction within threemonths prior to screening.

7. History of stroke or transient ischemic attack within six months prior to screening.

8. Participants meeting one or more of the following criteria at screening or baseline:

• Had an exacerbation of asthma requiring hospitalization in the preceding 12months.

• Reporting asthma that had not been well-controlled (i.e. symptoms occurring ongreater than (>) two days per week, night time awakenings two or more times perweek, or some interference with normal activities) during the preceding threemonths.

• Asthma Control Test (ACT) <= 19 (only for participants with a history ofasthma).

9. Cutaneous infection within one week before the baseline visit, any infectionrequiring treatment with oral or parenteral antibiotics, antivirals, antiparasiticsor antifungals within two weeks before the baseline visit.

10. Any confirmed or suspected coronavirus disease (COVID-19) infection within two weeksbefore the screening or baseline visit. Participants might be rescreened after theinfection had resolved. Resolution of COVID-19 infection could be confirmed byrecovery assessment methods, as described in the protocol.

11. Positive serology results (hepatitis B surface antigen [HbsAg] or hepatitis B coreantibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test forhepatitis C virus [HCV] (e.g., HCV polymerase chain reaction [PRC]), or humanimmunodeficiency virus [HIV] antibody) at the screening visit. Note: Participants with a positive HbcAb and a negative HbsAg could be included inthis clinical study if hepatitis B surface antibody was positive (considered immuneafter a natural infection or vaccination). Participants who were positive for HCVantibody and negative for HCV RNA might be enrolled. In the event of rescreening, the serology tests results (e.g., HBV, HCV, HIV) fromthe previous screening could be used by the investigator to assess the eligibilityof rescreened participants if those tests were performed within six weeks prior tothe baseline visit.

12. Known active or untreated latent tuberculosis (TB) infection or history of eitheruntreated or inadequately treated active or latent TB according to the localapplicable guidelines. Note: Participants who had a documented history of completion of an appropriate TBtreatment regimen for latent or active TB with no history of re-exposure to TB sincetheir treatment was completed were eligible to participate in the study.

13. Known or suspected immunosuppression beyond that expected due to end-stage kidneydisease and its comorbidities or unusually frequent, recurrent, severe, or prolongedinfections as per investigator judgment.

14. History of lymphoproliferative disease or history of malignancy of any organ systemwithin the last five years, except for (1) basal cell carcinoma, squamous cellcarcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that hadbeen treated and had no evidence of recurrence in the last 12 weeks before thebaseline visit, or (2) actinic keratoses that had been treated.

15. Pregnant women (positive serum pregnancy test result at any visits), breastfeedingwomen, or women planning a pregnancy during the clinical study.

16. In the opinion of the investigator the participant had any medical or psychologicalcondition that could pose undue risk to the participant, prevent study completion,or adversely affect the validity or interpretability of the study measurements orinterfered with study assessments.

17. Any clinically relevant laboratory abnormalities, such as but not limited toelevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (>3 *upper limit of normal [ULN]) in combination with elevated bilirubin (>2 * ULN),during the screening period that might put the participant at significant riskaccording to the investigator's judgment, if he/she participated in the clinicalstudy.

18. Planned or expected major surgical procedure during the clinical study, including ascheduled kidney transplant during the study.

19. Had not adhered to the restrictions in the selected medications prior to screeningor was not expected to be compliant with restrictions during the study.

20. Requiring rescue therapy for pruritus during the screening period or expected torequire rescue therapy within 4 weeks following the Baseline visit.

21. Previous treatment with nemolizumab.

22. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g. monoclonal antibody) or to any of the studydrug excipients.

23. Currently participating or participated in any other study of an investigationaldrug or device, within the past four weeks (or five half-lives of theinvestigational medication, whichever was longer) before the screening visit.

24. History of alcohol or substance abuse within six months of the screening visit.