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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:
This study will be done as follows:
Each participant will be in the study for about 22 weeks.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: AI versus PFS | Experimental | Participants will receive SC dose of litifilimab injection via AI or PFS on Day 1 of the study. |
|
| Part 2: OBI versus PFS | Experimental | Participants will receive SC dose of litifilimab injection via OBI or PFS on Day 1 of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litifilimab | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | 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 |
| 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) |
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Key Inclusion Criteria
Key Exclusion Criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Vegas Clinical Research Unit | Las Vegas | Nevada | 89113 | United States | ||
| Austin Clinical Research Unit |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| AI | Device | Administered as specified in the treatment arm. |
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| OBI | Device | Administered as specified in the treatment arm. |
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| PFS | Device | Administered as specified in the treatment arm. |
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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 |
| Austin |
| Texas |
| 78744 |
| United States |