Litifilimab for Healthy Subjects

Recruiting at 1 trial location

Overseen By US Biogen Clinical Trial Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Disqualifiers: Cardiac, Endocrine, HIV, Herpes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 days

404 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to deliver the medication litifilimab under the skin, using either an autoinjector or an on-body injector. The goal is to understand how these devices affect the body's processing of the medication compared to a standard pre-filled syringe. Researchers will monitor participants for blood levels of litifilimab, any side effects, and overall health changes. Ideal participants are healthy individuals with a body weight between 50 kg and 100 kg and a body mass index (BMI) between 18.5 and 30. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these devices are safe for delivering litifilimab?

Research has shown that litifilimab has generally been well tolerated in previous studies. Most reported side effects were mild or moderate, with common ones including diarrhea and cold-like symptoms, such as a sore throat and runny nose. Some participants also reported falls.

In some cases, more serious side effects like shingles and an eye infection called herpes keratitis occurred. Other possible reactions included upper respiratory infections and viral rashes. Despite these reports, most participants found the treatment manageable.

This study is in its early stages, focusing mainly on assessing the safety of litifilimab and its tolerability. The trial will help researchers learn more about any medical problems or reactions to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about litifilimab because it offers a novel approach by utilizing an innovative delivery method. Unlike traditional treatments that may use standard syringes, litifilimab is being explored with advanced delivery options like an autoinjector (AI) and an on-body injector (OBI). These methods could potentially enhance convenience and adherence for patients, making it easier to administer the medication. Additionally, these delivery methods may improve the precision of dosing, which is crucial for maximizing effectiveness and minimizing side effects.

What evidence suggests that these delivery methods for litifilimab are effective?

Research shows that litifilimab may help treat skin diseases. In earlier studies, participants who took litifilimab experienced better skin health after 16 weeks compared to those who took a placebo. The current trial aims to assess how the body handles litifilimab when using different injection devices. Participants will receive a subcutaneous dose of litifilimab via either an autoinjector (AI) or an on-body injector (OBI). Early results suggest it might help with conditions like lupus. Researchers are testing these devices to make administration easier and more effective. While more information is needed to confirm these benefits, the initial findings are promising. ^{6 7 8 9 10}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

This trial is for healthy individuals with a body mass index (BMI) between 18.5 and 30 kg/m^2, weighing at least 50 kg but not over 100 kg. They must be in good health as determined by medical history, physical exams, ECGs, and other evaluations.

Inclusion Criteria

I am in good health according to my doctor's evaluation.

My BMI is between 18.5 and 30, and my weight is between 50kg and 100kg.

I meet the main requirements to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Treatment

Participants receive SC injection(s) of litifilimab through AI, OBI, or PFS and remain at the research center for 8 days

8 days

Continuous stay at the research center

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetic parameters after treatment

17 weeks

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Litifilimab

Trial Overview Researchers are testing how litifilimab is processed when given under the skin using three methods: an autoinjector (AI), an on-body injector (OBI), or pre-filled syringes (PFS). The study compares the maximum blood levels of litifilimab and total exposure after dosing with each method.

How Is the Trial Designed?

Group I: Part 2: OBI versus PFS Experimental Treatment 3 Interventions

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

Group II: Part 1: AI versus PFS Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06741657

NCT06741657 | A Study to Find Out How Litifilimab is ... 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 ...

2. tipranks.com tipranks.com/news/company-announcements/biogens-innovative-litifilimab-study-a-potential-game-changer-in-drug-delivery

Biogen's Innovative Litifilimab Study: A Potential Game ... The study aims to evaluate how the body processes litifilimab when administered under the skin using three different devices, focusing on ...

3. investors.biogen.com investors.biogen.com/static-files/46900c9d-795d-4963-9431-728f4f846252

September 3, 2025 controlled Phase 3 studies to evaluate the efficacy and safety of litifilimab in patients with SLE receiving non-biologic SoC that are ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BIIB/pressreleases/35739380/biogens-innovative-study-on-litifilimab-delivery-market-implications-and-study-insights/

Biogen's Innovative Study on Litifilimab Delivery The study aims to understand how the body processes litifilimab when delivered subcutaneously through different devices, focusing on ...

5. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2024-a43ce

Litifilimab for Healthy Subjects This Phase 1 medical study run by Biogen is evaluating whether Litifilimab will have tolerable side effects & efficacy for patients with Healthy Subjects.

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2118025

Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus ... Diarrhea, nasopharyngitis, and falls were the adverse events that were reported in 5% or more of the participants in the pooled litifilimab ...

7. investors.biogen.com investors.biogen.com/news-releases/news-release-details/new-england-journal-medicine-publishes-positive-phase-2-data

The New England Journal of Medicine Publishes Positive ... In Part B, litifilimab was generally well tolerated, with most reported adverse events (AEs) rated as mild or moderate. The most common AEs ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36069871/

Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus ... Receipt of litifilimab was associated with adverse events, including two cases of herpes zoster and one case of herpes keratitis.

9. 2minutemedicine.com 2minutemedicine.com/litifilimab-associated-with-reduced-disease-severity-in-patients-with-cutaneous-lupus-erythematosus/

Litifilimab associated with reduced disease severity in ... 2. Litifilimab may increase the risk of adverse reactions including upper respiratory tract infection, influenza, herpes zoster, viral rash, and ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05352919

NCT05352919 | An Extension Study to Learn More About ... The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus ...