Recruiting
Phase 1

Empasiprubart

Sponsor:

argenx

Code:

NCT07612020

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

empasiprubart SC AI

empasiprubart IV

Study Details

Brief summary:

This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe.

The study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV.

Participants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.

Conditions

Healthy Volunteers

Study ID

NCT07612020

Start date

Mar 16, 2026

Status verified date

May, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
  • Has a body weight between 50 and 120 kg and a BMI between 18 and 35 kg/m2, inclusive.

Exclusion Criteria:

  • Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
  • Clinical diagnosis of SLE. For participants with an antinuclear antibody titer of ≥1:80 and a positive anti-double-stranded DNA and/or positive anti-Smith result at screening, an SLE diagnosis must be ruled out before the first IMP administration.
  • Previously participated in an empasiprubart clinical study and received at least 1 dose of IMP.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label treatment period (part A): empasiprubart SC AI (via abdomen)

Participants randomized to receive empasiprubart SC AI via abdomen.

experimental: Open-label treatment period (part A): empasiprubart SC AI (via thigh)

Participants randomized to receive empasiprubart SC AI via thigh.

experimental: Open-label treatment period (part A): empasiprubart IV

Participants randomized to receive empasiprubart IV.

experimental: Open-label treatment period (part B): empasiprubart SC AI

Participants randomized to receive empasiprubart IV and empasiprubart SC AI.

experimental: Open-label treatment period (part B): empasiprubart IV

Participants randomized to receive empasiprubart IV.

Interventions

empasiprubart SC AI

Subcutaneous injection of empasiprubart via Autoinjector (AI).

empasiprubart IV

Intravenous infusion of empasiprubart

Primary outcome measure

  • aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV [ Time Frame: Up to 33 weeks ]
  • aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV [ Time Frame: Up to 33 weeks ]
  • Ctrough at week 8 [ Time Frame: Up to 8 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Altasciences

Recruiting

Mount Royal, Quebec, Canada, H3P 3P1

Contacts

Gaetano Morelli, MD

+1 857-350-4834clinicaltrials@argenx.com

More Information

Sponsor

argenx

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by argenx on 2026-05-28.