ARGX-119 for ALS

(ReALiSe Trial)

Recruiting at 8 trial locations

Overseen By Sabine s Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: argenx

Disqualifiers: Ventilation, Gene therapies, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 48 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the purpose of this trial?

This study aims to evaluate the safety of ARGX-119 in adults with ALS. The study will also assess the impact of ARGX-119 on ALS disease outcomes, including muscle function. The study consists of 2 periods: a treatment period when participants will receive one of three ARGX-119 doses or placebo and an extension period when all participants will receive the same dose of ARGX-119. Participation in the study will last up to approximately 100 weeks.

Eligibility Criteria

This trial is for adults aged 18 to 80 with ALS, who have a specific risk profile and at least 60% normal lung function. It's open to those with familial or sporadic ALS as per Gold Coast criteria.

Inclusion Criteria

I have been diagnosed with ALS.

My ALS risk profile score is between -6.0 and -2.0.

My lung function test shows at least 60% of what is expected for someone my age and size.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three ARGX-119 doses or placebo intravenously during the double-blinded treatment period

Approximately 48 weeks

Extension

All participants receive the same dose of ARGX-119 in the active treatment extension period

Approximately 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARGX-119

Trial Overview The study tests ARGX-119's safety and its effect on muscle function in ALS patients. Participants will receive either ARGX-119 or a placebo during the treatment period, followed by an extension where all get ARGX-119.

Participant Groups

Group I: ARGX-119 - Dose 3 Experimental Treatment 1 Intervention

Participants will receive third dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period

Group II: ARGX-119 - Dose 2 Experimental Treatment 1 Intervention

Participants will receive second dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period

Group III: ARGX-119 - Dose 1 Experimental Treatment 1 Intervention

Participants will receive first dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period

Group IV: Placebo Placebo Group 2 Interventions

Participants will receive placebo intravenously during the double-blinded treatment period followed by ARGX-119 in active treatment extension period

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University