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Chronic Kidney Disease Associated Moderate to Severe PruritusPhase 2/3NIKAIA 1NCT05075408

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

A Phase 2/3 study testing Nemolizumab in people with Chronic Kidney Disease Associated Moderate to Severe Pruritus, run by Galderma R&D at 64 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nemolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
64 sitesin 4 countries
Study dates
18 Mar 2022to 4 Jan 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.
  • Women were 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.
  • Note: Bilateral tubal ligation was not accepted as reason for non-childbearing potential.
  • Participant was willing and able to comply with all time commitments and procedural requirements of the clinical study protocol.
  • Understands and signs an informed consent form (ICF) before any investigational procedure(s) were performed.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.
  • In the event of rescreening, the serology tests results (e.g., HBV, HCV, HIV) from the previous screening could be used by the investigator to assess the eligibility of rescreened participants if those tests were performed within six weeks prior to the baseline visit.
  • 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.
  • Note: Participants who had a documented history of completion of an appropriate TB treatment regimen for latent or active TB with no history of re-exposure to TB since their treatment was completed were eligible to participate in the study.
  • 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.
  • 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 had been treated and had no evidence of recurrence in the last 12 weeks before the baseline visit, or (2) actinic keratoses that had been treated.
  • Pregnant women (positive serum pregnancy test result at any visits), breastfeeding women, or women planning a pregnancy during the clinical study.
  • In the opinion of the investigator the participant had 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.
  • 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 might put the participant at significant risk according to the investigator's judgment, if he/she participated in the clinical study.
  • Planned or expected major surgical procedure during the clinical study, including a scheduled kidney transplant during the study.
  • Had not adhered to the restrictions in the selected medications prior to screening or was not expected to be compliant with restrictions during the study.
  • Requiring rescue therapy for pruritus during the screening period or expected to require rescue therapy within 4 weeks following the Baseline visit.
  • Previous treatment with nemolizumab.
  • 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.
  • 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 was longer) before the screening visit.
  • History of alcohol or substance abuse within six months of the screening visit.

Trial locations and contacts

64 sites in 4 countries.

64 sites in 4 countries

United States47 sites

  • Galderma Investigational Site 7039

    Arlington, Texas, 76015

  • Galderma Investigational Site 9989

    Bakersfield, California, 93309

  • Galderma Investigational Site 9988

    Bloomfield, Connecticut, 06002

  • Galderma Investigational Site 9970

    Boca Raton, Florida, 33421

  • Galderma Investigational Site 9967

    Chattanooga, Tennessee, 37404

  • Galderma Investigational Site 7027

    Columbus, Georgia, 31904

  • Galderma Investigational Site 7037

    Coral Gables, Florida, 33134

  • Galderma Investigational Site 7040

    Dallas, Texas, 75231

  • Galderma Investigational Site 9971

    Denver, Colorado, 80230

  • Galderma Investigational Site 7020

    Edina, Minnesota, 55435

  • Galderma Investigational Site 9966

    El Paso, Texas, 79925

  • Galderma Investigational Site 7038

    Fresh Meadows, New York, 11365

  • Galderma Investigational Site 9991

    Glendale, California, 91205

  • Galderma Investigational Site 7018

    Glendale, California, 91206

  • Galderma Investigational Site 9998

    Great Neck, New York, 11021

  • Galderma Investigational Site 9977

    Greenville, Texas, 75402

  • Galderma Investigational Site 7026

    Hollywood, Florida, 33021

  • Galderma Investigational Site 7011

    Houston, Texas, 77054

  • Galderma Investigational Site 7035

    Kansas City, Missouri, 64111

  • Galderma Investigational Site 7015

    La Palma, California, 90623

  • Galderma Investigational Site 9962

    Las Vegas, Nevada, 89128

  • Galderma Investigational Site 9996

    Los Angeles, California, 90048

  • Galderma Investigational Site 9978

    Lynwood, California, 90262

  • Galderma Investigational Site 7022

    McKinney, Texas, 75069

  • Galderma Investigational Site 9965

    Miami, Florida, 33125

  • Galderma Investigational Site7016

    Miami, Florida, 33155

  • Galderma Investigational Site 9980

    Middlebury, Connecticut, 06762

  • Galderma Investigational Site 9982

    Minneapolis, Minnesota, 55404

  • Galderma Investigational Site 9968

    Norfolk, Virginia, 23502

  • Galderma Investigational Site 9983

    Overland Park, Kansas, 66210

  • Galderma Investigational Site 7017

    Riverside, California, 92505

  • Galderma Investigational Site 9992

    Roseburg, Oregon, 97471

  • Galderma Investigational Site 9963

    Roseville, Michigan, 48066

  • Galderma Investigational Site 7010

    San Antonio, Texas, 78258

  • Galderma Investigational Site 7032

    Sanford, Florida, 32771

  • Galderma Investigational Site 9999

    Spartanburg, South Carolina, 29306

  • Galderma Investigational Site 7004

    Tampa, Florida, 33603

  • Galderma Investigational Site 7025

    Tampa, Florida, 33603

  • Galderma Investigational Site 9973

    Tarzana, California, 91356

  • Galderma Investigational Site 9995

    The Bronx, New York, 10461

  • Galderma Investigational Site 7019

    The Woodlands, Texas, 77384

  • Galderma Investigational Site 7028

    Victorville, California, 92392

  • Galderma Investigational Site 9964

    Victorville, California, 92394-1868

  • Galderma Investigational Site 9969

    Wauwatosa, Wisconsin, 53226

  • Galderma Investigational Site 7003

    Whittier, California, 90603

  • Galderma Investigational Site 9972

    Wichita, Kansas, 67214

  • Galderma Investigational Site 7007

    Winston-Salem, North Carolina, 27103

Other trials in United States

Spain8 sites

  • Galderma Investigational Site 6309

    Alcobendas, 28108

  • Galderma Investigational Site 6292

    Córdoba, 14004

  • Galderma Investigational Site 5580

    L'Hospitalet de Llobregat, 08097

  • Galderma Investigational Site 5171

    Madrid, 28040

  • Galderma Investigational Site 6190

    Madrid, 28046

  • Galderma Investigational Site 6278

    Manises, 46940

  • Galderma Investigational Site 6295

    Seville, 41009

  • Galderma Investigational Site 6311

    Valencia, 46017

Other trials in Spain

Hungary5 sites

  • Galderma Investigational Site 6301

    Budapest, 1076

  • Galderma Investigational Site 6304

    Kecskemét, 6000

  • Galderma Investigational Site 6305

    Miskolc, 3526

  • Galderma Investigational Site 6310

    Szentes, 6600

  • Galderma Investigational Site 6298

    Szombathely, 9700

Other trials in Hungary

Poland4 sites

  • Galderma Investigational Site 6294

    Brodnica, 87-300

  • Galderma Investigational Site 6296

    Lodz, 90-153

  • Galderma Investigational Site 6293

    Olkusz, 32-300

  • Galderma Investigational Site 6297

    Wroclaw, 50-556

Other trials in Poland

About this study

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

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.

Being tested
Nemolizumab, Placebo
Keywords
Chronic Kidney Disease, Moderate to Severe Pruritus, Nemolizumab, CD14152
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NemolizumabDrug

    Also called CD14152

    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.

  • NemolizumabDrug

    Also called CD14152

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

  • PlaceboDrug

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

Study groups in NCT05075408
Study groupRoleWhat they receive
Nemolizumab 30 mgExperimentalNot described
Receives: Drug: Nemolizumab
Nemolizumab 60 mgExperimentalNot described
Receives: Drug: Nemolizumab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, Week 12

Secondary outcomes (5)

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

    Responders are defined as participants with an improvement of >= 3 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the 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 >= 3 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).

    Measured: Baseline, Week 12

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

    Responders are defined as participants with an improvement of >= 4 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the 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 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 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).

    Measured: Baseline, Week 4

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

    Responders are participants with an improvement >= 4 in SD NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. SD NRS is a scale used by participants to report degree of their sleep loss related to chronic kidney disease with associated pruritus (CKD-aP ). Participants were asked 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 indicated worse outcome. Percentage of responders with an improvement of SD NRS >= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from 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).

    Measured: Baseline, Week 12

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

    Responders are defined as participants with an improvement of >= 3 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the 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 >= 3 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 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).

    Measured: Baseline, Week 4

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

    Responders are defined as participants with an improvement >= 4 in SD NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The SD NRS is a scale used by participants to report the degree of their sleep loss related to CKD-aP. Participants were 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 indicated worse outcome. Percentage of responders with an improvement of SD NRS >= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 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).

    Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start18 Mar 2022
  3. Primary completion4 Jan 2024
  4. Study completion4 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075408
Sponsor's protocol ID
RD.06.SPR.204358
Other IDs
2021-004766-35
Acronym
NIKAIA 1
Status last verified
Jan 2025
First submitted
30 Sep 2021
Last updated
1 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nemolizumab in people with Chronic Kidney Disease Associated Moderate to Severe Pruritus, run by Galderma R&D at 64 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Spain, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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