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

NCT ID: NCT06741657

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2026-04-08

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: AI versus PFS

Participants will receive SC dose of litifilimab injection via AI or PFS on Day 1 of the study.

Group Type: EXPERIMENTAL

Litifilimab

Intervention Type: DRUG

Administered as specified in the treatment arm.

AI

Intervention Type: DEVICE

Administered as specified in the treatment arm.

PFS

Intervention Type: DEVICE

Administered as specified in the treatment arm.

Part 2: OBI versus PFS

Participants will receive SC dose of litifilimab injection via OBI or PFS on Day 1 of the study.

Group Type: EXPERIMENTAL

Litifilimab

Intervention Type: DRUG

Administered as specified in the treatment arm.

OBI

Intervention Type: DEVICE

Administered as specified in the treatment arm.

PFS

Intervention Type: DEVICE

Administered as specified in the treatment arm.

Interventions

Litifilimab

Administered as specified in the treatment arm.

Intervention Type: DRUG

AI

Administered as specified in the treatment arm.

Intervention Type: DEVICE

OBI

Administered as specified in the treatment arm.

Intervention Type: DEVICE

PFS

Administered as specified in the treatment arm.

Intervention Type: DEVICE

Other Intervention Names

BIIB059

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Las Vegas Clinical Research Unit

Las Vegas, Nevada, United States

Austin Clinical Research Unit

Austin, Texas, United States

Countries

United States

Other Identifiers

230HV102

Identifier Type: -

Identifier Source: org_study_id