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Completed

NCT Number: NCT06741657

A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways

In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin.

In this study, researchers want to learn more about new ways of delivering litifilimab SC using either an autoinjector (AI) or an on-body injector (OBI):

Both devices are designed to deliver litifilimab in an automatic way, especially helping patients who may not be able to use their hands very well, or who may be afraid of needles. While the AI is handheld, the OBI device works by being placed on the skin and can help deliver the highest amount of litifilimab through a single injection. The main objective of this study is to learn how the body processes litifilimab after using the AI device or the OBI device, as compared to using the PFS method.

The main questions researchers want to answer are:

* What is the highest amount of litifilimab found in the blood after dosing? How much total litifilimab is found in the blood throughout the study? Researchers will also learn more about: Any medical problems the participants have during the study * Any injection site pain or reactions the participants may have. Any skin reactions to the OBI device * Any changes in the participants' overall health after receiving litifilimab.

This study will be done as follows:

* Participants will be screened to check if they can join the study. The screening period will be up to 4 weeks, after which selected participants will check into their study research center. * Participants will be randomly assigned to be in Part 1 or Part 2 of the study: * Part 1: Participants will receive SC injection(s) of litifilimab through either the AI device or through PFS. * Part 2: Participants will receive SC injection(s) of litifilimab through the OBI device or through PFS. * Participants will remain at their study research center for the first 8 days. After that, there will be a follow-up period for 17 weeks during which participants return to the center a total of 6 times.

Each participant will be in the study for about 22 weeks.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Las Vegas Clinical Research Unit, Las Vegas, Nevada, United States

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About this study

The primary objective of this study is to assess the pharmacokinetic (PK) comparability of litifilimab administered via SC injection(s) of AI (Test Device 1) or SC injection(s) of OBI (Test Device 2), with SC injections of PFS (Reference) in healthy participants.

The secondary objectives of this study are to evaluate the safety and tolerability following SC dose of litifilimab via AI, OBI, or PFS; to assess additional PK parameters following SC dose of litifilimab via AI, OBI, or PFS in healthy participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • Must have a body mass index between 18.5 and 30 kilograms per square meter (kg/m^2), and a body weight ≥ 50 kg to ≤ 100 kg.
  • Must be in good health as determined by the investigator, based on medical history physical examination, electrocardiogram (ECG), and other screening evaluations.

Key Exclusion Criteria

  • History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator.
  • A positive diagnostic tuberculosis test result within 4 weeks prior to Enrollment (Day 1), defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results.
  • History or positive test result for human immunodeficiency virus (HIV).
  • History of severe herpes infection such as herpetic encephalitis, ophthalmic herpes, or disseminated herpes.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Litifilimab

Drug

Administered as specified in the treatment arm.

Other names: BIIB059

AI

Device

Administered as specified in the treatment arm.

OBI

Device

Administered as specified in the treatment arm.

PFS

Device

Administered as specified in the treatment arm.

Primary outcomes

  1. Part 1 and 2: Maximum Observed Concentration (Cmax) of Litifilimab

    Time frame: Pre-dose and at multiple timepoints up to Week 22

  2. Part 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)

    Time frame: Pre-dose and at multiple timepoints up to Week 22

Secondary outcomes

  1. Part 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From screening up to Week 22

  2. Part 1 and 2: Change From Baseline in the Injection Site Pain as Measured by Patient Reported Outcome (PRO) Using a Pain Intensity Numeric Rating Scale (PI-NRS)

    Time frame: Baseline, Day 1

    A PI-NRS scale will be used to assess overall injection site pain at different time points. The scale ranges from 0 to 10 where '0' indicates 'no pain' and '7-10' indicates 'severe pain'.

  3. Part 1 and 2: Percentage of Participants With Mild, Moderate, Severe, or no Injection Site Reactions

    Time frame: Up to Week 1

  4. Part 2: Percentage of Participants With Adhesive Contact Skin Reactions as Measured by Dermal Response and Other Effects Scales

    Time frame: Up to Week 1

    A dermal response scale will be used to assess the adhesive contact skin reactions. The scale ranges from 0 to 7, where '0' indicates 'no evidence of irritation' and '7' indicates 'strong reaction spreading beyond the application site'. The other effects scale ranges from 'A(0)' to 'H(3)', where a 'A(0)' indicates a slightly glazed appearance and 'H(3)' indicates small petechial erosions and/or scabs.

  5. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Vital Signs Abnormalities

    Time frame: Baseline, up to Week 22

  6. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

    Time frame: Baseline, up to Week 4

  7. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Laboratory Evaluation Abnormalities

    Time frame: Baseline, up to Week 22

  8. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Physical Examination Abnormalities

    Time frame: Baseline, up to Week 22

  9. Part 1 and 2: Time to Reach Cmax (Tmax) of Litifilimab

    Time frame: Pre-dose and at multiple timepoints up to Week 22

  10. Part 1 and 2: Terminal Elimination Half-life (t1/2) of Litifilimab

    Time frame: Pre-dose and at multiple timepoints up to Week 22

  11. Part 1 and 2: Apparent Total Clearance (CL/F) of Litifilimab

    Time frame: Pre-dose and at multiple timepoints up to Week 22

  12. Part 1 and 2: Volume of Distribution (Vd/F) of Litifilimab

    Time frame: Pre-dose and at multiple timepoints up to Week 22

  13. Part 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Litifilimab

    Time frame: Pre-dose and at multiple timepoints up to Week 22

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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