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Healthy VolunteerPhase 1NCT06741657

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 Phase 1 study testing Litifilimab, AI and OBI in people with Healthy Volunteer, run by Biogen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Litifilimab, AI and OBI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
2 sitesUnited States
Study dates
2 Jan 2025to 10 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Austin Clinical Research Unit

    Austin, Texas, 78744

  • Las Vegas Clinical Research Unit

    Las Vegas, Nevada, 89113

Other trials in United States

About this study

Official 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

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):

Read more

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.

Read the 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.

Being tested
Litifilimab, AI, OBI, PFS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LitifilimabDrug

    Also called BIIB059

    Administered as specified in the treatment arm.

  • AIDevice

    Administered as specified in the treatment arm.

  • OBIDevice

    Administered as specified in the treatment arm.

  • PFSDevice

    Administered as specified in the treatment arm.

Study groups in NCT06741657
Study groupRoleWhat they receive
Part 1: AI versus PFSExperimentalParticipants will receive SC dose of litifilimab injection via AI or PFS on Day 1 of the study.
Receives: Drug: Litifilimab; Device: AI; Device: PFS
Part 2: OBI versus PFSExperimentalParticipants will receive SC dose of litifilimab injection via OBI or PFS on Day 1 of the study.
Receives: Drug: Litifilimab; Device: OBI; Device: PFS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

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

Secondary outcomes (13)

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

    Measured: 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)

    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'.

    Measured: Baseline, Day 1

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

    Measured: Up to Week 1

  4. 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.

    Measured: Up to Week 1

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

    Measured: 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

    Measured: Baseline, up to Week 4

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

    Measured: Baseline, up to Week 22

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

    Measured: Baseline, up to Week 22

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

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

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

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

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

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

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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start2 Jan 2025
  3. Primary completion10 Mar 2026
  4. Study completion10 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741657
Sponsor's protocol ID
230HV102
Status last verified
May 2026
First submitted
15 Dec 2024
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Litifilimab, AI and OBI in people with Healthy Volunteer, run by Biogen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and 2: Maximum Observed Concentration (Cmax) of Litifilimab (time frame: Pre-dose and at multiple timepoints up to Week 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06741657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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