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

NCT06741657 | Completed Phase 1 FDA Drug

• 1 other identifier: 230HV102
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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)

  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

  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

Study Arms (2)

Part 1: AI versus PFS

EXPERIMENTAL

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

Drug: Litifilimab; Device: AI; Device: PFS

Part 2: OBI versus PFS

EXPERIMENTAL

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

Drug: Litifilimab; Device: OBI; Device: PFS

Interventions

Litifilimab DRUG

Administered as specified in the treatment arm.

Also known as: BIIB059

Part 1: AI versus PFS; Part 2: OBI versus PFS

AI DEVICE

Administered as specified in the treatment arm.

Part 1: AI versus PFS

OBI DEVICE

Administered as specified in the treatment arm.

Part 2: OBI versus PFS

PFS DEVICE

Administered as specified in the treatment arm.

Part 1: AI versus PFS; Part 2: OBI versus PFS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Las Vegas Clinical Research Unit

Las Vegas, Nevada, 89113, United States

Location

Austin Clinical Research Unit

Austin, Texas, 78744, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: January 2, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)