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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05075408
• Collaborator: (none)
• Enrollment: 252
• Locations: 73
• Arms: 3
• Anticipated Duration (Months): 25.1
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of nemolizumab compared to placebo at improving the intensity of pruritus after a 12-week treatment period in adult hemodialysis participants with moderate to severe pruritus.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Associated Moderate to Severe Pruritus	Drug: Nemolizumab; Drug: Nemolizumab; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: This is a double-blind study. The randomization code will remain blinded to all participants, study sites personnel and Sponsor/CRO study team members until completion of the study and after the study database has been locked.
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects With Chronic Kidney Disease With Associated Moderate to Severe Pruritus
• Actual Study Start Date: Dec 29, 2021
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nemolizumab 30 mg	Drug: Nemolizumab; Participants will receive 2 subcutaneous injections for a total dose of 30 milligrams (mg) of nemolizumab every 4 weeks (Q4W), with a loading dose of 60 mg at baseline for a period of 12 weeks with an 8 week follow-up.; Other Names: CD14152
Experimental: Nemolizumab 60 mg	Drug: Nemolizumab; Participants will receive 2 subcutaneous injections of 30 mg of nemolizumab Q4W starting at baseline for a period of 12 weeks with an 8 week follow-up.; Other Names: CD14152
Placebo Comparator: Placebo	Drug: Placebo; Participants will receive 2 subcutaneous injections of 30 mg of placebo-matched to nemolizumab Q4W for a period of 12 weeks with an 8 week follow-up.

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants with an Improvement of >=4 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 12 [Baseline, Week 12]

   The WI NRS is a scale that will be used by the participants to report the intensity of their worst pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Secondary Outcome Measures

1. Proportion of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 12 [Baseline, Week 12]

   The WI NRS is a scale that will be used by the participants to report the intensity of their worst pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

2. Proportion of Participants with an Improvement of >=4 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4 [Baseline, Week 4]

   The WI NRS is a scale that will be used by the participants to report the intensity of their worst pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

3. Proportion of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 12 [Baseline, Week 12]

   The SD NRS is a scale that will be used by the participants to report the degree of their sleep loss related to chronic kidney disease with associated pruritus. Participants will be asked the following question: On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus, how would you rate your sleep last night?'. Higher scores indicate worse outcome.

4. Proportion of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4 [Baseline, Week 4]

   The WI NRS is a scale that will be used by the participants to report the intensity of their worst pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

5. Proportion of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 4 [Baseline, Week 4]

   The SD NRS is a scale that will be used by the participants to report the degree of their sleep loss related to chronic kidney disease with associated pruritus. Participants will be asked the following question: On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus, how would you rate your sleep last night?'. Higher scores indicate worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Has end-stage renal disease (ESRD) and have been on hemodialysis three times per week for at least three months prior to the start of screening.

2. Hemodialysis participants meeting the Kidney Outcome Quality Initiative Guidelines of hemodialysis adequacy within 60 days of screening, two single-pools of: -Kt/V at least 1.2.

3. Pruritus for >= three months (documented pruritus with no etiology identified other than CKD by medical record, previous physician's letter/statement, or a written conversation of site investigators).

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

5. Women of childbearing potential (WOCBP) (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the participant, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study injection.

Adequate and approved methods of contraception applicable for the participant and/or her partner are 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, or transdermal 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 least three months before the study.

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

1. Women are considered to be of non-childbearing potential if they meet one of the following criteria:

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

• Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least three months before screening.

1. Participant willing and able to comply with all time commitments and procedural requirements of the clinical study protocol.

2. Understands and signs an informed consent form (ICF) before any investigational procedure(s) are performed.

Exclusion Criteria:

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

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

3. Localized itch of only the palms of the hands.

4. Pruritus present only during hemodialysis session.

5. Non-compliance with hemodialysis in the opinion of the investigator.

6. New York Heart Association Class IV symptoms or myocardial infarction within three months 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 12 months.

• Reporting asthma that has not been well-controlled (i.e. symptoms occurring on greater than (>) two days per week, nighttime awakenings two or more times per week, or some interference with normal activities) during the preceding three months.

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

1. Cutaneous infection within one week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within two weeks before the baseline visit.

2. Any confirmed or suspected coronavirus disease (COVID-19) infection within two weeks before the screening or baseline visit. Participants may be rescreened after the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods, as described in the protocol.

3. Positive serology results (hepatitis B surface antigen [HbsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for hepatitis C virus [HCV] (e.g., HCV polymerase chain reaction [PRC]), or human immunodeficiency virus [HIV] antibody) at the screening visit.

4. Known active or untreated latent tuberculosis (TB) infection or history of either untreated or inadequately treated active or latent TB according to the local applicable guidelines.

5. Known or suspected immunosuppression beyond that expected due to end-stage kidney disease and its comorbidities or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.

6. History of lymphoproliferative disease or history of malignancy of any organ system within the last five 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 baseline visit, or (2) actinic keratoses that have been treated.

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

8. In the opinion of the investigator the participant has any medical or psychological condition that could pose undue risk to the participant, prevent study completion, or adversely affect the validity or interpretability of the study measurements or interfered with study assessments.

9. Any clinically relevant laboratory abnormalities, such as but not limited to elevated 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 may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study.

10. Planned or expected major surgical procedure during the clinical study, including a scheduled kidney transplant during the study.

11. Has not adhered to the restrictions in the selected medications prior to screening or is not expected to be compliant with restrictions during the study.

12. Requiring rescue therapy for pruritus during the screening period or expected to require rescue therapy within 4 weeks following the Baseline visit.

13. Previous treatment with nemolizumab.

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

15. Currently participating or participated in any other study of an investigational drug or device, within the past four weeks (or five half-lives of the investigational medication, whichever is longer) before the screening visit.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational Site 9993	Hoover	Alabama	United States	35242
2	Galderma Investigational Site 7005	Huntsville	Alabama	United States	35805
3	Galderma Investigational Site 9981	Phoenix	Arizona	United States	85012
4	Galderma Investigational Site 9989	Bakersfield	California	United States	93309
5	Galderma Investigational Site 7013	Fresno	California	United States	93720
6	Galderma Investigational Site 9991	Glendale	California	United States	91205
7	Galderma Investigational Site 7018	Glendale	California	United States	91206
8	Galderma Investigational Site 7015	La Palma	California	United States	90623
9	Galderma Investigational Site 9996	Los Angeles	California	United States	90048
10	Galderma Investigational Site 9978	Lynwood	California	United States	90262
11	Galderma Investigational Site 7017	Riverside	California	United States	92505
12	Galderma Investigational Site 9973	Tarzana	California	United States	91356
13	Galderma Investigational Site 7028	Victorville	California	United States	92392
14	Galderma Investigational Site 9964	Victorville	California	United States	92394-1868
15	Galderma Investigational Site 7003	Whittier	California	United States	90603
16	Galderma Investigational Site 9971	Denver	Colorado	United States	80230
17	Galderma Investigational Site 9988	Bloomfield	Connecticut	United States	06002
18	Galderma Investigational Site 9980	Middlebury	Connecticut	United States	06762
19	Galderma Investigational Site 9970	Boca Raton	Florida	United States	33421
20	Galderma Investigational Site7016	Coral Gables	Florida	United States	33134
21	Galderma Investigational Site 7014	Coral Springs	Florida	United States	32071
22	Galderma Investigational Site 7026	Hollywood	Florida	United States	33021
23	Galderma Investigational Site 9965	Miami	Florida	United States	33125
24	Galderma Investigational Site 7032	Sanford	Florida	United States	32771
25	Galderma Investigational Site 7004	Tampa	Florida	United States	33603
26	Galderma Investigational Site 7025	Tampa	Florida	United States	33603
27	Galderma Investigational Site 7027	Columbus	Georgia	United States	31904
28	Galderma Investigational Site 9984	Nampa	Idaho	United States	83687
29	Galderma Investigational Site 9990	Chicago	Illinois	United States	60643
30	Galderma Investigational Site 9983	Overland Park	Kansas	United States	66210
31	Galderma Investigational Site 9972	Wichita	Kansas	United States	67214
32	Galderma Investigational Site 7029	Springfield	Massachusetts	United States	01107
33	Galderma Investigational Site 9963	Roseville	Michigan	United States	48066
34	Galderma Investigational Site 7020	Edina	Minnesota	United States	55435
35	Galderma Investigational Site 9982	Minneapolis	Minnesota	United States	55404
36	Galderma Investigational Site 9994	Tupelo	Mississippi	United States	38801
37	Galderma Investigational Site 9962	Las Vegas	Nevada	United States	89128
38	Galderma Investigational Site 9995	Bronx	New York	United States	10461
39	Galderma Investigational Site 9998	Great Neck	New York	United States	11021
40	Galderma Investigational Site 7007	Winston-Salem	North Carolina	United States	27103
41	Galderma Investigational Site 9992	Roseburg	Oregon	United States	97471
42	Galderma Investigational Site 9999	Spartanburg	South Carolina	United States	29306
43	Galderma Investigational Site 9967	Chattanooga	Tennessee	United States	37404
44	Galderma Investigational Site 9966	El Paso	Texas	United States	79925
45	Galderma Investigational Site 9977	Greenville	Texas	United States	75402
46	Galderma Investigational Site 7011	Houston	Texas	United States	77054
47	Galderma Investigational Site 7006	McAllen	Texas	United States	78503
48	Galderma Investigational Site 7022	McKinney	Texas	United States	75069
49	Galderma Investigational Site 7010	San Antonio	Texas	United States	78258
50	Galderma Investigational Site 7019	The Woodlands	Texas	United States	77384
51	Galderma Investigational Site 9968	Norfolk	Virginia	United States	23502
52	Galderma Investigational Site 9969	Wauwatosa	Wisconsin	United States	53226
53	Galderma Investigational Site 6301	Budapest		Hungary	1076
54	Galderma Investigational Site 5264	Debrecen		Hungary	4012
55	Galderma Investigational Site 6304	Kecskemét		Hungary	6000
56	Galderma Investigational Site 6305	Miskolc		Hungary	3526
57	Galderma Investigational Site 6310	Szentes		Hungary	6600
58	Galderma Investigational Site 6298	Szombathely		Hungary	9700
59	Galderma Investigational Site 6294	Brodnica		Poland	87-300
60	Galderma Investigational Site 6300	Nakło Nad Notecią		Poland	89-100
61	Galderma Investigational Site 6293	Olkusz		Poland	32-300
62	Galderma Investigational Site 6291	Warszawa		Poland	02-758
63	Galderma Investigational Site 6297	Wrocław		Poland	50-556
64	Galderma Investigational Site 6296	Łódź		Poland	90-153
65	Galderma Investigational Site 6302	Żary		Poland	68-200
66	Galderma Investigational Site 6309	Alcobendas		Spain	28108
67	Galderma Investigational Site 6292	Córdoba		Spain	14004
68	Galderma Investigational Site 5580	L'Hospitalet De Llobregat		Spain	08097
69	Galderma Investigational Site 5171	Madrid		Spain	28040
70	Galderma Investigational Site 6190	Madrid		Spain	28046
71	Galderma Investigational Site 6278	Manises		Spain	46940
72	Galderma Investigational Site 6295	Sevilla		Spain	41009
73	Galderma Investigational Site 6311	Valencia		Spain	46017

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT05075408
• Other Study ID Numbers: RD.06.SPR.204358; 2021-004766-35
• First Posted: Oct 12, 2021
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Galderma R&D: Chronic Kidney Disease; Moderate to Severe Pruritus; Nemolizumab; CD14152
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Pruritus

Study Results

No Results Posted as of Aug 23, 2022