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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Litifilimab; Device: AI; Device: PFS; Device: OBI

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.

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Clinical Research Unit
  • Texas
    • Austin, Texas, United States, 78744
      • Austin Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: AI versus PFS; Participants will receive SC dose of litifilimab injection via AI or PFS on Day 1 of the study.	Drug: Litifilimab; Administered as specified in the treatment arm.; Other Names: BIIB059; Device: AI; Administered as specified in the treatment arm.; Device: PFS; Administered as specified in the treatment arm.
Experimental: Part 2: OBI versus PFS; Participants will receive SC dose of litifilimab injection via OBI or PFS on Day 1 of the study.	Drug: Litifilimab; Administered as specified in the treatment arm.; Other Names: BIIB059; Device: PFS; Administered as specified in the treatment arm.; Device: OBI; Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1 and 2: Maximum Observed Concentration (Cmax) of Litifilimab	Pre-dose and at multiple timepoints up to Week 22
Part 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)	Pre-dose and at multiple timepoints up to Week 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		From screening up to Week 22
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)	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'.	Baseline, Day 1
Part 1 and 2: Percentage of Participants With Mild, Moderate, Severe, or no Injection Site Reactions		Up to Week 1
Part 2: Percentage of Participants With Adhesive Contact Skin Reactions as Measured by Dermal Response and Other Effects Scales	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.	Up to Week 1
Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Vital Signs Abnormalities		Baseline, up to Week 22
Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities		Baseline, up to Week 4
Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Laboratory Evaluation Abnormalities		Baseline, up to Week 22
Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Physical Examination Abnormalities		Baseline, up to Week 22
Part 1 and 2: Time to Reach Cmax (Tmax) of Litifilimab		Pre-dose and at multiple timepoints up to Week 22
Part 1 and 2: Terminal Elimination Half-life (t1/2) of Litifilimab		Pre-dose and at multiple timepoints up to Week 22
Part 1 and 2: Apparent Total Clearance (CL/F) of Litifilimab		Pre-dose and at multiple timepoints up to Week 22
Part 1 and 2: Volume of Distribution (Vd/F) of Litifilimab		Pre-dose and at multiple timepoints up to Week 22
Part 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Litifilimab		Pre-dose and at multiple timepoints up to Week 22

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): March 10, 2026

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 230HV102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No