> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-find-out-how-litifilimab-is-processed-in-the-body-8cf31b4c-cb0c-4bdc-af2c-a813de5b2e3e > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) Participants 404 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) Lead sponsor Biogen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) Start date 2025-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Short title** A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Dates **Completion date** 2026-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **First posted** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Registry last updated** 2026-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Primary completion date** 2026-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Start date** 2025-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Size and sites **Actual participants** 404 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Participants** 404 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Lead sponsor** Biogen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Identifiers **Registry ID** NCT06741657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **ClinicalTrials.gov ID** NCT06741657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Outcomes ### Primary outcomes 1. Part 1 and 2: Maximum Observed Concentration (Cmax) of Litifilimab Timeframe: 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) Timeframe: Pre-dose and at multiple timepoints up to Week 22 ### Secondary outcomes 1. Part 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Timeframe: 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) Timeframe: Baseline, Day 1 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'. 3. Part 1 and 2: Percentage of Participants With Mild, Moderate, Severe, or no Injection Site Reactions Timeframe: Up to Week 1 4. Part 2: Percentage of Participants With Adhesive Contact Skin Reactions as Measured by Dermal Response and Other Effects Scales Timeframe: Up to Week 1 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. 5. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Vital Signs Abnormalities Timeframe: 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 Timeframe: Baseline, up to Week 4 7. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Laboratory Evaluation Abnormalities Timeframe: Baseline, up to Week 22 8. Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Physical Examination Abnormalities Timeframe: Baseline, up to Week 22 9. Part 1 and 2: Time to Reach Cmax (Tmax) of Litifilimab Timeframe: Pre-dose and at multiple timepoints up to Week 22 10. Part 1 and 2: Terminal Elimination Half-life (t1/2) of Litifilimab Timeframe: Pre-dose and at multiple timepoints up to Week 22 11. Part 1 and 2: Apparent Total Clearance (CL/F) of Litifilimab Timeframe: Pre-dose and at multiple timepoints up to Week 22 12. Part 1 and 2: Volume of Distribution (Vd/F) of Litifilimab Timeframe: 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 Timeframe: Pre-dose and at multiple timepoints up to Week 22 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Sites - Las Vegas Clinical Research UnitLas Vegas, United States - Austin Clinical Research UnitAustin, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06741657) ## Related records ### Drugs (1) - [Litifilimab](https://trialight.com/data/asset/litifilimab-7b0edbb2-543a-4a80-9535-9455f1432e2a.md) ### Lead sponsors (1) - [Biogen](https://trialight.com/data/company/biogen-f4a36ded-071a-4089-ac47-d219e9d21c44.md) ### Targets (1) - [CLEC4C](https://trialight.com/data/target/clec4c-3a0e0bbf-e22d-5b05-8801-ee683a6db606.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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