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

NCT05075408 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: RD.06.SPR.2043582021-004766-35
• Study Type: interventional
• Target: 258
• Locations: 4 countries
• Sites: 64

Brief Summary

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

Conditions

Chronic Kidney Disease Associated Moderate to Severe Pruritus

Keywords

Chronic Kidney Disease; Moderate to Severe Pruritus; Nemolizumab; CD14152

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12

  Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or Adverse event(AE)/death related to study drug. The WI NRS is a scale that is used by responders to report intensity of their worst pruritus (itch) during last 24 hours. Participants were asked following question: For worst itch intensity:"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae).

  Baseline, Week 12

Secondary Outcomes (5)

• Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12

  Baseline, Week 12

• Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4

  Baseline, Week 4

• Percentage of Responders With an Improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 From Baseline at Week 12

  Baseline, Week 12

• Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 4

  Baseline, Week 4

• Percentage of Responders With an Improvement of SD NRS >= 4 From Baseline at Week 4

  Baseline, Week 4

Study Arms (3)

Nemolizumab 30 mg

EXPERIMENTAL

Drug: Nemolizumab

Nemolizumab 60 mg

EXPERIMENTAL

Drug: Nemolizumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nemolizumab DRUG

Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 Subcutaneous (SC) injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.

Also known as: CD14152

Nemolizumab 30 mg

Placebo DRUG

Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged \>= 18 years at the screening visit.
• Had end-stage kidney disease (ESKD) and had been on hemodialysis three times per week for at least three months prior to the start of screening.
• Note 1: Participants who required an occasional additional hemodialysis treatment to manage fluid overload might be enrolled as long as it was anticipated that no more than one such treatment would be required in any given week.
• Note 2: Participants had received in-home hemodialysis might participated as long as they had switched to in-center hemodialysis at least two weeks prior to screening and plan to remain on in-center hemodialysis for the duration of the study.
• Hemodialysis participants meeting the Kidney Outcome Quality Initiative Guidelines of hemodialysis adequacy within 60 days of screening, two:
• Single-poolsKt/V measurements of at least 1.2.
• 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 based on the medical history obtained from the participant).
• WI NRS score \>= 5.0 at the screening and baseline visit. Screening WI NRS score would 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 would 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 was not permitted). A minimum of four daily scores out of the seven days immediately preceding baseline was required for this calculation.
• Women of childbearing potential (WOCBP) (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agreed either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this was 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 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, or transdermal hormonal contraception.
• Injectable or implanted hormonal contraception.
• Intrauterine devices or intrauterine hormone releasing system.

You may not qualify if:

• Body weight less than (\<) 30 kg.
• Pruritus caused by a concomitant condition unrelated to ESKD (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).
• Localized itch of only the palms of the hands and/or soles of the feet.
• Pruritus present only during hemodialysis session.
• History of or anticipated non-compliance with hemodialysis (i.e, such that it would adversely affect the conduct of the study or significantly change dialysis adequacy during the study) in the opinion of the investigator.
• New York Heart Association Class IV symptoms or myocardial infarction within three months prior to screening.
• History of stroke or transient ischemic attack within six months prior to screening.
• 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 had not been well-controlled (i.e. symptoms occurring on greater than (\>) two days per week, night time 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).
• 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.
• Any confirmed or suspected coronavirus disease (COVID-19) infection within two weeks before the screening or baseline visit. Participants might be rescreened after the infection had resolved. Resolution of COVID-19 infection could be confirmed by recovery assessment methods, as described in the protocol.
• 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.
• Note: Participants with a positive HbcAb and a negative HbsAg could be included in this clinical study if hepatitis B surface antibody was positive (considered immune after a natural infection or vaccination). Participants who were positive for HCV antibody and negative for HCV RNA might be enrolled.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (64)

Galderma Investigational Site 9989

Bakersfield, California, 93309, United States

Location

Galderma Investigational Site 9991

Glendale, California, 91205, United States

Location

Galderma Investigational Site 7018

Glendale, California, 91206, United States

Location

Galderma Investigational Site 7015

La Palma, California, 90623, United States

Location

Galderma Investigational Site 9996

Los Angeles, California, 90048, United States

Location

Galderma Investigational Site 9978

Lynwood, California, 90262, United States

Location

Galderma Investigational Site 7017

Riverside, California, 92505, United States

Location

Galderma Investigational Site 9973

Tarzana, California, 91356, United States

Location

Galderma Investigational Site 7028

Victorville, California, 92392, United States

Location

Galderma Investigational Site 9964

Victorville, California, 92394-1868, United States

Location

Galderma Investigational Site 7003

Whittier, California, 90603, United States

Location

Galderma Investigational Site 9971

Denver, Colorado, 80230, United States

Location

Galderma Investigational Site 9988

Bloomfield, Connecticut, 06002, United States

Location

Galderma Investigational Site 9980

Middlebury, Connecticut, 06762, United States

Location

Galderma Investigational Site 9970

Boca Raton, Florida, 33421, United States

Location

Galderma Investigational Site 7037

Coral Gables, Florida, 33134, United States

Location

Galderma Investigational Site 7026

Hollywood, Florida, 33021, United States

Location

Galderma Investigational Site 9965

Miami, Florida, 33125, United States

Location

Galderma Investigational Site7016

Miami, Florida, 33155, United States

Location

Galderma Investigational Site 7032

Sanford, Florida, 32771, United States

Location

Galderma Investigational Site 7004

Tampa, Florida, 33603, United States

Location

Galderma Investigational Site 7025

Tampa, Florida, 33603, United States

Location

Galderma Investigational Site 7027

Columbus, Georgia, 31904, United States

Location

Galderma Investigational Site 9983

Overland Park, Kansas, 66210, United States

Location

Galderma Investigational Site 9972

Wichita, Kansas, 67214, United States

Location

Galderma Investigational Site 9963

Roseville, Michigan, 48066, United States

Location

Galderma Investigational Site 7020

Edina, Minnesota, 55435, United States

Location

Galderma Investigational Site 9982

Minneapolis, Minnesota, 55404, United States

Location

Galderma Investigational Site 7035

Kansas City, Missouri, 64111, United States

Location

Galderma Investigational Site 9962

Las Vegas, Nevada, 89128, United States

Location

Galderma Investigational Site 7038

Fresh Meadows, New York, 11365, United States

Location

Galderma Investigational Site 9998

Great Neck, New York, 11021, United States

Location

Galderma Investigational Site 9995

The Bronx, New York, 10461, United States

Location

Galderma Investigational Site 7007

Winston-Salem, North Carolina, 27103, United States

Location

Galderma Investigational Site 9992

Roseburg, Oregon, 97471, United States

Location

Galderma Investigational Site 9999

Spartanburg, South Carolina, 29306, United States

Location

Galderma Investigational Site 9967

Chattanooga, Tennessee, 37404, United States

Location

Galderma Investigational Site 7039

Arlington, Texas, 76015, United States

Location

Galderma Investigational Site 7040

Dallas, Texas, 75231, United States

Location

Galderma Investigational Site 9966

El Paso, Texas, 79925, United States

Location

Galderma Investigational Site 9977

Greenville, Texas, 75402, United States

Location

Galderma Investigational Site 7011

Houston, Texas, 77054, United States

Location

Galderma Investigational Site 7022

McKinney, Texas, 75069, United States

Location

Galderma Investigational Site 7010

San Antonio, Texas, 78258, United States

Location

Galderma Investigational Site 7019

The Woodlands, Texas, 77384, United States

Location

Galderma Investigational Site 9968

Norfolk, Virginia, 23502, United States

Location

Galderma Investigational Site 9969

Wauwatosa, Wisconsin, 53226, United States

Location

Galderma Investigational Site 6301

Budapest, 1076, Hungary

Location

Galderma Investigational Site 6304

Kecskemét, 6000, Hungary

Location

Galderma Investigational Site 6305

Miskolc, 3526, Hungary

Location

Galderma Investigational Site 6310

Szentes, 6600, Hungary

Location

Galderma Investigational Site 6298

Szombathely, 9700, Hungary

Location

Galderma Investigational Site 6294

Brodnica, 87-300, Poland

Location

Galderma Investigational Site 6296

Lodz, 90-153, Poland

Location

Galderma Investigational Site 6293

Olkusz, 32-300, Poland

Location

Galderma Investigational Site 6297

Wroclaw, 50-556, Poland

Location

Galderma Investigational Site 6309

Alcobendas, 28108, Spain

Location

Galderma Investigational Site 6292

Córdoba, 14004, Spain

Location

Galderma Investigational Site 5580

L'Hospitalet de Llobregat, 08097, Spain

Location

Galderma Investigational Site 5171

Madrid, 28040, Spain

Location

Galderma Investigational Site 6190

Madrid, 28046, Spain

Location

Galderma Investigational Site 6278

Manises, 46940, Spain

Location

Galderma Investigational Site 6295

Seville, 41009, Spain

Location

Galderma Investigational Site 6311

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sponsor
• Organization: Galderma Research & Development, LLC

aestheticclinicaltrials@galderma.com

8179615000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This was a double-blind study. The randomization code remained blinded to all participants, study sites personnel and Sponsor/CRO study team members until completion of the study and after the study database had been locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 12, 2021
• Study Start: March 18, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: May 1, 2026
• Results First Posted: February 20, 2025

Record last verified: 2025-01

Locations

ES (8); HU (5); US (47); PL (4)