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Autoimmune and Chronic Inflammatory DiseasesPhase 1NCT07032272

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

A Phase 1 study testing remibrutinib in people with Autoimmune and Chronic Inflammatory Diseases, run by Novartis Pharmaceuticals at 4 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
remibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
4 sitesUnited States
Study dates
23 Jul 2025to 14 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All participants (Group 1 \& 2)
  • Male and non-childbearing potential female participants 18 to 75 years of age, inclusive, at Screening.
  • Must be a non-smoker or a light smoker who smokes no more than 10 cigarettes (or equivalent, including use of nicotine products) per day, at Screening. Smokers must agree to smoke no more than 5 cigarettes (or equivalent) per day from check-in until after Study Completion evaluations.
  • Participants with severe RI (Group 1)
  • Must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18.0 to 35.0 kg/m2, inclusive, at Screening.
  • Seated vital signs must be within the following ranges at Screening and Baseline:
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  • body temperature, 35.0 to 37.5°C, inclusive.
  • systolic blood pressure, 90 to 159 mmHg, inclusive.
  • diastolic blood pressure, 60 to 99 mmHg, inclusive.
  • pulse rate, 50 to 99 bpm, inclusive.
  • Have impaired renal function as determined by eGFR using the CKD-EPI Creatinine - Cystatin C equation (2021), in the following group at Screening: severe RI; eGFR <30 mL/min, not requiring dialysis.
  • Have stable renal function with no clinically significant change in renal status prior to first dosing of study treatment as determined by the Investigator and is not currently or has not been previously on hemodialysis for at least 1 year. Participants with other stable medical disorders such as controlled diabetes, hyperlipidemia, hypothyroidism, arterial hypertension etc., may be eligible as long as they are considered appropriate for enrollment as determined by the Investigator by past medical history, physical examination, ECG, and clinical laboratory tests at Screening.
  • Healthy control participants (Group 2)
  • Each healthy participant must match the age (± 10 years), body weight (± 20%), race, ethnicity and sex of an individual participant in Group 1.
  • Must weigh at least 50 kg to participate in the study and must have a BMI within the range of 18.0 to 35.0 kg/m2 inclusive, at Screening.
  • Must be in good health as determined by medical history, physical examination, ECG, vital signs and clinical laboratory tests at Screening.
  • Has normal renal function with eGFR greater than or equal to 90 mL/min, determined using the CKD-EPI Creatinine - Cystatin C equation (2021) at Screening. Actual creatinine clearance computed over a 24-hour urine collection may be used in place of or in conjunction with the CKD-EPI Creatinine - Cystatin C equation (2021), at the Investigator's discretion.

Who cannot join

  • All participants (Group 1 \& 2)
  • Use of other investigational drugs within 5 half-lives or 30 days prior to first dosing of study treatment, whichever is longer, as far as known.
  • History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
  • Use of prescription drugs, OTC medications, or herbal supplements (within the last 2 weeks prior to first dosing, or use of cannabis/marijuana, within the last 4 weeks prior to initial dosing.
  • Participants not willing to abstain from food and beverages known to inhibit or induce CYP3A4 from 7 days prior to first dosing and until their respective EoS visit.
  • History or presence of malignancy of any organ system (other than treated localized basal cell or squamous cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years of Screening, regardless of whether there is evidence of local recurrence or metastases.
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  • History or presence of any ongoing, chronic or recurrent infectious disease (including tuberculosis, atypical mycobacterioses, listeriosis, aspergillosis).
  • Participants with a history of bone marrow failure or cytopenia will be excluded from the study.
  • Is on immunosuppressant therapy or immunomodulators therapy less than or equal to 4 weeks prior to first dosing.
  • Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) or alkaline phosphatase (ALP) exceeding 1.2 x upper limit of normal (ULN) or greater than or equal to 1.5 x ULN total bilirubin (TBL) OR any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or TBL.
  • Known or suspected diagnosis of Gilbert's syndrome.
  • Participants with severe RI (Group 1)
  • Clinically significant abnormal findings in physical examination, ECG, or clinical laboratory evaluations, extending over findings related to the known renal disease.
  • Participants having had myocardial infarction < 2 years of Screening are not eligible to participate, participants having had myocardial infarction greater than or equal to 2 years of Screening can be eligible to participate.
  • Clinically significant illness within 2 weeks prior to first dosing that may jeopardize safety of the study participant and/or alter the study results as judged by the Investigator.
  • Participants with end stage renal disease requiring dialysis.
  • Healthy control participants (Group 2)
  • Any clinical laboratory parameters (e.g. hemoglobin, platelets, leukocytes, neutrophils) outside of local laboratory ranges at Screening unless judged not clinically significant by the Investigator.
  • Significant illness which has not resolved within 2 weeks prior to first dosing of study treatment.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Clinical Pharmacology of Miami LLC

    Miami, Florida, 33014-3616

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • Genesis Clinical Research

    Tampa, Florida, 33614

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Severe Renal Impairment Compared to Matched Healthy Participants With Normal Renal Function

The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.

Read the detailed description

This is a Phase 1, open-label, non-randomized study to evaluate the PK after five administrations of remibrutinib in participants with severe RI compared to matched healthy control participants with normal renal function.The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.

Being tested
remibrutinib
Keywords
Remibrutinib (LOU064), Renal impairment, PK, Safety, Tolerability
Medical subject headings
Renal Insufficiency

What participants receive

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

  • remibrutinibDrug

    Tablet with oral route of administration

Study groups in NCT07032272
Study groupRoleWhat they receive
Participants with severe renal impairmentExperimentalParticipants with severe renal impairment will receive remibrutinib
Receives: Drug: remibrutinib
Healthy participantsExperimentalMatched healthy participants will receive remibrutinib
Receives: Drug: remibrutinib

What is being measured

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

  1. Cmax, ss of remibrutinib in blood

    The maximum (peak) observed concentration following multiple-dose administration

    Measured: Up to 72 hours postdose

  2. AUCtau,ss of remibrutinib in blood

    The area under the curve (AUC) from time zero to the end of the dosing interval (tau) following multiple-dose administration

    Measured: Up to 72 hours postdose

  3. Ae0-12h,ss of remibrutinib in urine

    Amount of unchanged drug excreted in the urine collection interval from time zero to 12 hours following multiple-dose administration

    Measured: Up to 12 hours postdose

  4. CLr,ss of remibrutinib in urine

    Renal clearance following multiple-dose administration

    Measured: Up to 12 hours postdose

Secondary outcomes (9)

  1. Number of participants with adverse events and serious adverse events

    Number of participants with adverse events and serious adverse events

    Measured: From Day 1 to end of study (up to 30 days after last administration of study treatment)

  2. Plasma protein binding of remibrutinib (unbound fraction)

    Fraction unbound based on protein binding data

    Measured: 1 hour postdose

  3. Cmax,ss,u of remibrutinib in plasma

    The maximum (peak) observed unbound plasma drug concentration following multiple-dose administration

    Measured: Up to 72 hours post dose

  4. AUCtau,ss,u of remibrutinib in plasma

    The unbound AUC calculated to the end of a dosing interval (tau) following multiple dose administration

    Measured: Up to 72 hours post dose

  5. AUClast,ss,u of remibrutinib in plasma

    The AUC from time zero to the last measurable unbound concentration sampling time (tlast) following multiple-dose administration

    Measured: Up to 72 hours post dose

  6. AUClast,ss of remibrutinib in blood

    The AUC from time zero to the last measurable concentration sampling time

    Measured: Up to 72 hours postdose

  7. Tmax,ss of remibrutinib in blood

    The time to reach maximum (peak) concentration following multiple-dose administration

    Measured: Up to 72 hours postdose

  8. T1/2 of remibrutinib in blood

    The elimination half-life associated with the terminal slope

    Measured: Up to 72 hours postdose

  9. CL/F,ss of remibrutinib in blood

    Oral clearance following multiple-dose administration

    Measured: Up to 72 hours postdose

Timeline

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

  1. First posted22 Jun 2025
  2. Study start23 Jul 2025
  3. Primary completion12 Oct 2025
  4. Study completion14 Oct 2025

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07032272
Sponsor's protocol ID
CLOU064A2105
Status last verified
Mar 2026
First submitted
19 Jun 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing remibrutinib in people with Autoimmune and Chronic Inflammatory Diseases, run by Novartis Pharmaceuticals at 4 sites in United States.

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 17 inclusion and 19 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cmax, ss of remibrutinib in blood (time frame: Up to 72 hours postdose). The study lists 4 primary outcomes in all. 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 NCT07032272.

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 27 Oct 2026.

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