Efgartigimod SC for Myositis

(ALKIVIA+ Trial)

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: argenx

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to check the safety and effectiveness of an injectable medication called efgartigimod PH20 SC in adults with muscle inflammation who participated in an earlier phase. The medication works by reducing harmful proteins that cause muscle problems.

Research Team

Eligibility Criteria

This trial is for adults with active Idiopathic Inflammatory Myopathy (IIM) who completed the ARGX-113-2007 study. Participants must be able to consent, follow the study plan, and use contraception if of childbearing potential. Exclusions include planned major surgery, new medical conditions that risk safety or skew results, known drug hypersensitivity, any cancer except basal cell skin carcinoma, or previous discontinuation from the related trial.

Inclusion Criteria

Has completed trial ARGX-113-2007

Being capable of providing signed informed consent and complying with protocol requirements

Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the investigational medicinal product

Exclusion Criteria

I have not developed any new or recurrent cancer, except for basal cell skin cancer.

Known hypersensitivity reaction to investigational medicinal product or 1 of its excipients

Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit

Treatment Details

Interventions

• Efgartigimod (Monoclonal Antibodies)

Trial Overview The trial tests long-term safety and effectiveness of a subcutaneous injection called efgartigimod PH20 SC in those with IIM. It's for people who've had it before in an earlier phase of research and looks at how well they tolerate it over time as well as its ongoing benefits.

Participant Groups

Group I: EFG PH20 SC Experimental Treatment 1 Intervention

participants receiving efgartigimod PH20 SC on top of background treatment

Efgartigimod is already approved in Canada, Japan for the following indications:

Approved in Canada as Vyvgart for:

• Generalized Myasthenia Gravis (gMG)

Approved in Japan as Vyvgart for:

• Generalized Myasthenia Gravis (gMG)

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