empasiprubart (ARGX-117) / argenx, Broteio - LARVOL DELTA

VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (clinicaltrials.gov) - P2 | N=103 | Active, not recruiting | Sponsor: argenx | Trial completion date: Jul 2026 ➔ May 2030

Trial completion date • Transplantation

embridge: A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome (clinicaltrials.gov) - P2 | N=63 | Not yet recruiting | Sponsor: argenx

New P2 trial

EmpaSound: A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Complement-mediated Rare Disorders

ADAPT Forward2: ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • CNS Disorders • Myasthenia Gravis

Empasiprubart Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMNERGIZE Phase 3 Study Design (CNSF 2026) - P3 | "This phase 3 study will compare the efficacy and safety of empasiprubart versus placebo in patients with CIDP, focusing on functional ability, muscle strength/function, clinical status, gait impairment, and patient-reported outcomes."

Clinical • P3 data • CNS Disorders

Empasiprubart vs Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMVIGORATE Phase 3 Study Design (CNSF 2026) - P3 | "The complement system plays a key role in promoting macrophage-mediated demyelination...This study will compare the efficacy and safety of empasiprubart IV and IVIg in CIDP, focusing on functional ability, muscle strength/function, gait performance, and patient-reported outcomes."

P3 data • CNS Disorders

Long-Term Safety and Efficacy Data of Empasiprubart in Multifocal Motor Neuropathy: Phase 2 ARDA+ Study (ICNMD 2026) - P2 | "In ARDA+, participants receiving EMPA maintained improvements across measured efficacy and safety endpoints, while those who switched from PBO experienced new improvements after EMPA initiation, supporting complement system involvement in MMN pathophysiology."

Clinical • P2 data • Complement-mediated Rare Disorders

Design of Phase 2a Study Evaluating Empasiprubart Add-On Therapy to Efgartigimod in Adults With gMG (ICNMD 2026) - P2 | "Results of this study will provide proof-of-concept data on empasiprubart as an add-on therapy to efgartigimod for adults with AChR-Ab+ gMG."

Clinical • P2a data • CNS Disorders • Myasthenia Gravis

Evaluation of the Effect of Empasiprubart on Nerve Morphology in Multifocal Motor Neuropathy: Study Design (ICNMD 2026) - "This phase 1b, open-label, single treatment group study will evaluate the effect of empasiprubart IV on nerve morphology by ultrasound and changes in clinical outcome measures in adults with MMN."

CNS Disorders • Complement-mediated Rare Disorders • Immunology • Inflammation

Empasiprubart Versus Placebo (EMNERGIZE) or Immunoglobulin (EMVIGORATE) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Study Designs (ICNMD 2026) - P3 | "These two global phase 3 studies will evaluate the efficacy and safety of empasiprubart in participants with CIDP. Similar designs and endpoints with complementary study populations support the potential role of empasiprubart as a reference treatment across patients with CIDP, regardless of treatment status."

Clinical

Patient‑Reported Outcomes and Safety From the Phase 2 ARDA Study of Empasiprubart in Multifocal Motor Neuropathy (EAN 2026) - P2 | "Empasiprubart improved PROs versus placebo, with patients consistently reporting less fatigue and better quality of life."

Clinical • P2 data • Patient reported outcomes • Complement-mediated Rare Disorders

Empasiprubart Versus Placebo (EMNERGIZE) or Immunoglobulin (EMVIGORATE) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Study Designs (EAN 2026) - P3 | "These two global phase 3 studies will evaluate the efficacy and safety of empasiprubart in participants with CIDP. Similar designs and endpoints with complementary study populations support the potential role of empasiprubart as a reference treatment across patients with CIDP, regardless of treatment status. FIGURE 1 EMNERGIZE study design."

Clinical

ADAPT Forward2: ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: argenx

Monotherapy • New P2 trial • CNS Disorders • Myasthenia Gravis

emlight: A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (clinicaltrials.gov) - P2/3 | N=6 | Not yet recruiting | Sponsor: argenx

New P2/3 trial • Pain

A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: argenx

Head-to-Head • New P1 trial

EmpaSound: A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: argenx

New P1 trial • Complement-mediated Rare Disorders • Pain

Empassion: A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P3 | N=154 | Active, not recruiting | Sponsor: argenx | Recruiting ➔ Active, not recruiting | N=115 ➔ 154

Enrollment change • Enrollment closed • Complement-mediated Rare Disorders • Pain

emnergize: A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: argenx

Trial initiation date • Pain

Advancing empasiprubart (GlobeNewswire) - "Topline results from EMPASSION study (MMN) expected in fourth quarter of 2026...Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027...Decision for Phase 2 VARVARA study (Delayed Graft Function) expected mid-year 2026 following completion of 52-week efficacy analysis...ADAPT-Forward combination study ongoing to evaluate empasiprubart as an add on therapy to efgartigimod in gMG."

P2 data • P3 data: top line • Trial status • Antibody-mediated Rejection • Immunology • Inflammation • Myasthenia Gravis

Structure-function analysis of empasiprubart, a calcium- and pH-dependent clinical phase complement C2 blocking antibody. (PubMed, MAbs) - "Our observations indicate that the pH-dependent target release is rooted in a subtle intramolecular complementarity-determining region (CDR) destabilization, rather than direct modulation of the binding interface, and highlight the interplay between framework residues and CDRs. Collectively, our results not only lead to a better understanding of the mode of action of empasiprubart but also demonstrate the pivotal role of framework residues in the orchestration of antibody CDR function for non-trivial target binding."

Journal

Empassion: A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P3 | N=115 | Recruiting | Sponsor: argenx | Active, not recruiting ➔ Recruiting

Enrollment open • Complement-mediated Rare Disorders • Pain

Design of a Phase 2a Study to Evaluate the Safety, Efficacy, and Tolerability of Intravenous Empasiprubart as an Add-On Therapy to Intravenous Efgartigimod in Adult Participants With Generalized Myasthenia Gravis (AAN 2026) - "Participants not meeting partial response criteria during Part A proceed to Part C. Results Primary endpoints will evaluate safety and tolerability during Parts A and B. Secondary endpoints will evaluate efficacy, including MG-ADL. Conclusions Results of this study will provide proof-of-concept data on empasiprubart as an add-on therapy to efgartigimod for adults with AChR-Ab+ gMG."

Clinical • P2a data • CNS Disorders • Myasthenia Gravis

Empasiprubart vs Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMVIGORATE Phase Three Study Design (AAN 2026) - "The complement system plays a key role in promoting macrophage-mediated demyelination...Secondary endpoints (Week 24) include changes from baseline in Inflammatory Rasch-Built Overall Disability Scale score, Medical Research Council sum score, dominant hand grip strength and Timed Up and Go, time to decrease of ≥1 point in aINCAT score, and Patient Global Impression of Change actual values. Conclusions This Phase 3 study will compare the efficacy and safety of empasiprubart IV and IVIg in CIDP, focusing on functional ability, muscle strength/function, gait performance, and patient-reported outcomes."

Pain

Empasiprubart Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMNERGIZE Phase Three Study Design (AAN 2026) - "Key secondary endpoints include changes from baseline at Week 24 in Inflammatory Rasch-Built Overall Disability Scale score, Medical Research Council Sum score, dominant hand grip strength, and Timed Up and Go, and time to reduction of ≥1 point versus baseline in aINCAT score. Conclusions This Phase 3 study will compare the efficacy and safety of empasiprubart versus placebo in patients with CIDP, focusing on functional ability, muscle strength/function, clinical status, gait impairment, and patient-reported outcomes."

Clinical • Immunology • Pain

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: argenx | N=52 ➔ 70

Enrollment change • Trial initiation date • CNS Disorders • Myasthenia Gravis